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The coronavirus struck the world globally very unexpectedly and with it spreading extremely fast scientists are quickly trying to find a cure(or are they? that's a conspiracy for another day). While there is no cure doctors are currently using an antiviral called "Remdesivir" as a testing to see if it could help cure COVID-19. This antiviral was once used to help cure the Ebola virus and even though it didn't help that much with the Ebola they wanted to give it a try with COVID-19. They are using this antiviral on adults who have been diagnosed with the coronavirus and as of right now there are no updates on how it's working, but they are trying.

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While no specific treatment for coronavirus disease 2019 (COVID-19) is currently available, several therapies are being investigated globally.*

ENU200: An orally delivered antiviral compound previously approved to treat other infections. In-silico modeling conducted by Ennaid has revealed that ENU200 delivers specific antiviral activity against 2 SARS-CoV-2 proteins, S glycoprotein and Mpro. The Company believes it can quickly bring ENU200 to market by treating patients with COVID-19 in a phase 3 in-home, self-dosing clinical trial of patients with asymptomatic, mild to moderate coronavirus infections.

Lopinavir/ritonavir: AbbVie is collaborating with select health authorities and institutions to determine the antiviral activity of the HIV drug against COVID-19. Recent trial results published in the New England Journal of Medicine showed that the combination therapy was not associated with clinical improvement in patients with confirmed COVID-19.

Remdesivir: The broad-spectrum antiviral agent, developed by Gilead, is being investigated in a double-blinded, placebo-controlled study sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). In addition, The Company is initiating two phase 3 trials to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19, following a rapid review and acceptance by the Food and Drug Administration (FDA) of the investigational new drug filing for the novel antiviral.

Oxypurinol: XORTX Therapeutics is exploring the use of a new formulation of oxypurinol as a novel treatment for acute kidney and lung injury accompanying COVID-19 infection.

Immunotherapies and Other Investigational Therapies

ACE-MAB: Sorrento Therapeutics is developing a bi-specific fusion protein that binds to the spike protein of coronaviruses, which is expected to block SARS-CoV-2 from binding and infecting respiratory epithelial cells or ACE2-expressing cells.

Inhaled nitric oxide: The FDA has granted emergency expanded access for use of the INOpulse® system (Bellerophon Therapeutics) and the Genosyl DS tankless system (VERO Biotech) for treatment of COVID-19. In a clinical study of patients infected with SARS-CoV, nitric oxide demonstrated improvements in arterial oxygenation.

LEAPS peptides: CEL-SCI is developing an immunotherapy using a patented T cell modulation peptide epitope delivery technology, to stimulate protective cell-mediated T cell responses and reduce viral load.

Mavrilimumab: Kiniksa is investigating a fully-human monoclonal antibody designed to antagonize granulocyte macrophage colony stimulating factor (GM-CSF) signaling by binding to the alpha subunit of the GM-CSF receptor (GM-CSFRα). In a prospective, interventional, single-active-arm, single-center pilot study, patients with severe pulmonary involvement of COVID-19, acute respiratory distress, fever, and clinical and biological markers of systemic hyperinflammation status​ were treated with a single intravenous dose of mavrilimumab. To date, 6 patients have been treated; patients showed early resolution of fever and improvement in oxygenation within 1-3 days.

Sargramostim: A yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) being assessed in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Sargramostim is marketed under the brand name Leukine ( Partner Therapeutics) in the US.

Siltuximab: A study has been initiated at the Papa Giovanni XXIII Hospital, Bergamo Italy, to investigate the use of the interleukin (IL)-6 targeted monoclonal antibody for the treatment of patients with COVID-19 who have developed serious respiratory complications (Siltuximab In Serious COVID-19; SISCO study). Interim data from the first 21 patients show that 7 patients experienced clinical improvement with a reduced need for oxygen support and 9 patients had no clinically relevant changes; worsening was seen in 3 patients and 1 patient died. In the US, siltuximab ( Sylvant; EUSA Pharma) is currently approved for multicentric Castleman disease in adults who are HIV negative and human herpesvirus-8 (HHV-8) negative.

ST266: A cell-free platform biologic containing hundreds of anti-inflammatory proteins. According to Noveome Biotherapeutics, its lead product candidate has the potential to treat severe inflammatory cytokine storm observed in COVID-19 patients. Human clinical trials are expected by the fourth quarter 2020.

TAK-888: An anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) being developed by Takeda for high-risk individuals with COVID-19. Pathogen-specific antibodies from plasma will be collected from recovered patients (or vaccinated donors in the future) and will be transferred to sick patients to improve the immune response to the infection and increase the chance of recovery.

Tradipitant: A neurokinin-1 receptor antagonist being evaluated by Vanda Pharmaceuticals for the treatment and prevention of pneumonia associated with COVID-19. The phase 3 ODYSSEY study will include 300 patients with severe infection.

TZLS-501: The investigational therapy, being developed by Tiziana, has been shown to rapidly deplete circulating levels of IL-6 in the blood, a key driver of chronic inflammation. Excessive production of IL-6 is believed to be associated with severe lung damage observed with COVID-19 infections.

Altimmune Inc: Developing a single-dose, intranasal vaccine against COVID-19 using its proprietary NasoVAX technology. The vaccine is moving toward animal testing.

Applied DNA Sciences: Collaborating with Takis Biotech to develop a DNA vaccine candidate using PCR-based DNA ("LinearDNA") manufacturing systems; preclinical testing in animals is expected to begin in the second quarter of 2020.

Codagenix Inc: Co-developing a live-attenuated vaccine with the Serum Institute of India using viral deoptimization.

GlaxoSmithKline: Collaborating with Clover Biopharmaceuticals to develop a protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) using Clover's proprietary technology (Timer-Tag©) and combining it with GSK's pandemic adjuvant system.

Inovio Pharmaceuticals: Developing a DNA vaccine (INO-4800) to address COVID-19; human trials to begin in the US in April.

Johnson & Johnson: Partnering with the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine using Janssen's AdVac® and PER.C6® technology, which provide the ability to rapidly upscale production of an optimal vaccine candidate.

Moderna Inc: Vials of the Company's mRNA vaccine (mRNA-1273) have been shipped to the National Institute of Allergy and Infectious Diseases to be used in a phase 1 study in the US. The Company is actively preparing for a potential phase 2 trial based on the outcomes of the NIH study.

Novavax: Currently evaluating multiple recombinant nanoparticle vaccine candidates in animal models; initiation of phase 1 testing is expected in late spring of 2020. The COVID-19 vaccine candidates will likely include the saponin-based Matrix-M™ adjuvant to enhance immune responses.

Pfizer and BioNTech: Co-developing a potential first-in-class COVID-19 mRNA-based vaccine candidate (BNT162), which is expected to enter clinical testing by the end of April 2020.

Sanofi: Collaborating with BARDA to develop a vaccine using Sanofi's recombinant DNA platform. The DNA sequence encoding the antigen will be combined into the DNA of the baculovirus expression platform and used to produce large quantities of the coronavirus antigen which will be formulated to stimulate the immune system to protect against the virus.

Sorrento Therapeutics: Developing STI-6991, an I-Cell TM COVID-19 cellular vaccine made of replication-deficient human erythroleukemia K562 cells expressing membrane-bound S1 protein of the SARS-CoV-2 virus. The I-Cell vaccine is expected to elicit both T cell and B cell immunities against SARS-CoV-2.

* Not an inclusive list. Updates will be made as more information becomes available.

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Pipeline: Investigational Therapies for COVID-19 - MPR

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While no specific treatment for coronavirus disease 2019 (COVID-19) is currently available, several therapies are being investigated globally.* ENU200: An orally delivered antiviral compound previously approved to treat other infections. In-silico modeling conducted by Ennaid has revealed that ENU200 delivers specific antiviral activity against 2 SARS-CoV-2 proteins, S glycoprotein and Mpro.

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The coronavirus has quickly spread across the world within the past month. As a response to this increasing global health issue, certain therapies have began to be used, such as the new drug  "Remdesivir."  The drug was previously used to treat the Ebola virus in the DR Congo. While first being tested with the Ebola virus, the drug showed little to no effect.

However, when tested on coronaviruses that cause SARS or MERS, the drug had been known to inhibit spread of such viruses. It had also been recently tested on a man who had tested positive of COVID-19 in the United States. After his initial critically ill condition, his symptoms dramatically improved. However, experts say that the drug isn't necessary for much of the patients who aren't diagnosed - even the ones with apparent symptoms.

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A drug combo already used against HIV. A malaria treatment first tested during World War II. A new antiviral whose promise against Ebola fizzled last year.

Could any of these drugs hold the key to saving coronavirus disease 2019 (COVID-19) patients from serious harm or death? On Friday, the World Health Organization (WHO) announced a large global trial, called SOLIDARITY, to find out whether any can treat infections with the new coronavirus for the dangerous respiratory disease. It's an unprecedented effort-an all-out, coordinated push to collect robust scientific data rapidly during a pandemic. The study, which could include many thousands of patients in dozens of countries, has been designed to be as simple as possible so that even hospitals overwhelmed by an onslaught of COVID-19 patients can participate.

With about 15% of COVID-19 patients suffering from severe disease and hospitals being overwhelmed, treatments are desperately needed. So rather than coming up with compounds from scratch that may take years to develop and test, researchers and public health agencies are looking to repurpose drugs already approved for other diseases and known to be largely safe. They're also looking at unapproved drugs that have performed well in animal studies with the other two deadly coronaviruses, which cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

Drugs that slow or kill the novel coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), could save the lives of severely ill patients, but might also be given prophylactically to protect health care workers and others at high risk of infection. Treatments may also reduce the time patients spend in intensive care units, freeing critical hospital beds.

Scientists have suggested dozens of existing compounds for testing, but WHO is focusing on what it says are the four most promising therapies: an experimental antiviral compound called remdesivir; the malaria medications chloroquine and hydroxychloroquine; a combination of two HIV drugs, lopinavir and ritonavir; and that same combination plus interferon-beta, an immune system messenger that can help cripple viruses. Some data on their use in COVID-19 patients have already emerged-the HIV combo failed in a small study in China-but WHO believes a large trial with a greater variety of patients is warranted.

Enrolling subjects in SOLIDARITY will be easy. When a person with a confirmed case of COVID-19 is deemed eligible, the physician can enter the patient's data into a WHO website, including any underlying condition that could change the course of the disease, such as diabetes or HIV infection. The participant has to sign an informed consent form that is scanned and sent to WHO electronically. After the physician states which drugs are available at his or her hospital, the website will randomize the patient to one of the drugs available or to the local standard care for COVID-19.

"After that, no more measurements or documentation are required," says Ana Maria Henao-Restrepo, a medical officer at WHO's Department of Immunization Vaccines and Biologicals. Physicians will record the day the patient left the hospital or died, the duration of the hospital stay, and whether the patient required oxygen or ventilation, she says. "That's all."

The design is not double-blind, the gold standard in medical research, so there could be placebo effects from patients knowing they received a candidate drug. But WHO says it had to balance scientific rigor against speed. The idea for SOLIDARITY came up less than 2 weeks ago, Henao-Restrepo says, and the agency hopes to have supporting documentation and data management centers set up next week. "We are doing this in record time," she says.

It will be important to get answers quickly, to try to find out what works and what doesn't work. We think that randomized evidence is the best way to do that.

Ana Maria Henao-Restrepo, World Health Organization

Arthur Caplan, a bioethicist at New York University Langone Medical Center, says he likes the study's design. "No one wants to tax the frontline caregiver who's overwhelmed and taking risks anyway," Caplan says. Hospitals that aren't overburdened might be able to record more data on disease progression, for instance by following the level of virus in the body, Caplan suggests. But for public health, the simple outcomes WHO seeks to measure are the only relevant ones for now, says virologist Christian Drosten of the Charité University Hospital in Berlin: "We don't really know enough about this disease to be sure what it means when the viral load decreases in the throat, for instance."

On Sunday, INSERM, the French biomedical research agency, announced it will coordinate an add-on trial in Europe, named Discovery, that will follow WHO's example and will include 3200 patients from at least seven countries, including 800 from France. That trial will test the same drugs, with the exception of chloroquine. Other countries or groups of hospitals could organize add-on studies as well, Heneo-Restrepo says. They are free to do additional measurements or observations, for instance on virology, blood gases, chemistry, and lung imaging. "While well-organized additional research studies of the natural history of the disease or of the effects of the trial treatments could well be valuable, they are not core requirements," she says.

The list of drugs to test was first put together for WHO by a panel of scientists who have been assessing the evidence for candidate therapies since January, Heneo-Restrepo says. The group of selected drugs that had the highest likelihood of working, had the most safety data from previous use, and are likely to be available in supplies sufficient to treat substantial numbers of patients if the trial shows they work.

Here are the treatments that SOLIDARITY will test:

Remdesivir

The new coronavirus is giving this compound a second chance to shine. Originally developed by Gilead Sciences to combat Ebola and related viruses, remdesivir shuts down viral replication by inhibiting a key viral enzyme, the RNA-dependent RNA polymerase.

Researchers tested remdesivir last year during the Ebola outbreak in the Democratic Republic of the Congo, along with three other treatments. It did not show any effect. (Two others did.) But the enzyme it targets is similar in other viruses, and in 2017 researchers at the University of North Carolina, Chapel Hill, showed in test tube and animal studies that the drug can inhibit the coronaviruses that cause SARS and MERS.

The first COVID-19 patient diagnosed in the United States-a young man in Snohomish county in Washington-was given remdesivir when his condition worsened; he improved the next day, according to a case report in The New England Journal of Medicine (NEJM). A Californian patient who received remdesivir-and who doctors thought might not survive- recovered as well.

Such evidence from individual cases doesn't prove a drug is safe and effective. Still, from the drugs in the SOLIDARITY trial, "remdesivir has the best potential to be used in clinics" says Jiang Shibo of Fudan University, who has long worked on coronavirus therapeutics. Jiang particularly likes that high doses of the drug can likely be given without causing toxicities.

However, it may be much more potent if given early in an infection, like most other drugs, says Stanley Perlman, a coronavirus researcher at the University of Iowa. "What you really want to do is give a drug like that to people who walk in with mild symptoms," he says. "And you can't do that because it's an [intravenous] drug, it's expensive and 85 out of 100 people don't need it."

Chloroquine and hydroxychloroquine

At a press conference on Friday, President Donald Trump called chloroquine and hydroxychloroquine a "game changer." "I feel good about it," Trump said. His remarks have led to a rush in demand for the decades-old antimalarials. ("It reminds me a little bit of the toilet paper phenomenon and everybody's running to the store," Caplan says.)

The WHO scientific panel designing SOLIDARITY had originally decided to leave the duo out of the trial, but had a change of heart at a meeting in Geneva on 13 March, because the drugs "received significant attention" in many countries, according to the report of a WHO working group that looked into the drugs' potential. The widespread interested prompted "the need to examine emerging evidence to inform a decision on its potential role."

The available data are thin. The drugs work by decreasing the acidity in endosomes, compartments inside cells that they use to ingest outside material and that some viruses can coopt to enter a cell. But the main entryway for SARS-CoV-2 is a different one, using its so-called spike protein to attach to a receptor on the surface of human cells. Studies in cell culture have suggested chloroquines have some activity against SARS-CoV-2, but the doses needed are usually high-and could cause serious toxicities.

Encouraging cell study results with chloroquines against two other viral diseases, dengue and chikungunya, didn't pan out in people in randomized clinical trials. And nonhuman primates infected with chikungunya did worse when given chloroquine. "Researchers have tried this drug on virus after virus, and it never works out in humans. The dose needed is just too high," says Susanne Herold, an expert on pulmonary infections at the University of Giessen.

Results from COVID-19 patients are murky. Chinese researchers who report treating more than 100 patients with chloroquine touted its benefits in a letter in BioScience, but the data underlying the claim have not been published. All in all, more than 20 COVID-19 studies in China used chloroquine or hydroxychloroquine, WHO notes, but their results have been hard to come by. "WHO is engaging with Chinese colleagues at the mission in Geneva and have received assurances of improved collaboration; however, no data has been shared regarding the chloroquine studies."

Researchers in France have published a study in which they treated 20 COVID-19 patients with hydroxychloroquine. They concluded that the drug significantly reduced viral load in nasal swabs. But it was not a randomized controlled trial and it didn't report clinical outcomes such as deaths. In guidance published on Friday, the U.S. Society of Critical Care Medicine said "there is insufficient evidence to issue a recommendation on the use of chloroquine or hydroxychloroquine in critically ill adults with COVID-19."

Hydroxychloroquine, in particular, might do more harm than good. The drug has a variety of side effects and can in rare cases harm the heart. Because people with heart conditions are at higher risk of severe COVID-19, that is a concern, says David Smith, an infectious disease physician at the University of California, San Diego. "This is a warning signal, but we still need to do the trial," he says. What's more, a rush to use the drug for COVID-19 might make it harder for the people who need it to treat their rheumatoid arthritis or malaria.

Ritonavir/lopinavir

This combination drug, sold under the brand name Kaletra, was approved in the United States in 2000 to treat HIV infections. Abbott Laboratories developed lopinavir specifically to inhibit the protease of HIV, an important enzyme that cleaves a long protein chain into peptides during the assembly of new viruses. Because lopinavir is quickly broken down in the human body by our own proteases, it is given with low levels of ritonavir, another protease inhibitor, that lets lopinavir persist longer.

The combination can inhibit the protease of other viruses as well, specifically coronaviruses. It has shown efficacy in marmosets infected with the MERS virus, and has also been tested in SARS and MERS patients, though results from those trials are ambiguous.

The first trial with COVD-19 was not encouraging, however. Doctors in Wuhan, China, gave 199 patients two pills of lopinavir/ritonavir twice a day plus standard care, or standard care alone. There was no significant difference between the groups, they reported in NEJM on 15 March. But the authors caution that patients were very ill-more than one-fifth of them died-and so the treatment may have been given too late to help. Although the drug is generally safe it may interact with drugs usually given to severely ill patients, and doctors have warned it could cause significant liver damage.

Ritonavir/lopinavir and interferon-beta

SOLIDARITY will also have an arm that combines the two antivirals with interferon-beta, a molecule involved in regulating inflammation in the body that has also shown an effect in marmosets infected with MERS. A combination of the three drugs is now being tested in MERS patients in Saudi Arabia in the first randomized controlled trial for that disease.

But the use of interferon-beta on patients with severe COVID-19 might be risky, Herold says. "If it is given late in the disease it could easily lead to worse tissue damage instead of helping patients," she cautions.

Thousands of patients

The design of the SOLIDARITY trial can change at any time. A global data safety monitoring board will look at interim results at regular intervals and decide whether any member of the quartet has a clear effect, or whether one can be dropped because it clearly does not. Several other drugs, including the influenza drug favipiravir, produced by Japan's Toyama Chemical, may be added to the trial.

To get robust results from the study, several thousands of patients will likely have to be recruited, Henao-Restrepo says. Argentina, Iran, South Africa, and several other non-European countries have already signed up. WHO is also hoping to do a prevention trial to test drugs that might protect health care workers from infection, using the same basic protocol, Henao-Restrepo says.

The trial's European counterpart, Discovery, will recruit patients from France, Spain, the United Kingdom, Germany, and the Benelux countries, according to an INSERM press release today. The trial will be led Florence Ader, an infectious diseases researcher at the University Hospital Center in Lyon.

Doing rigorous clinical research during an outbreak is always a challenge, Henao-Restrepo says, but it's the best way to make headway against the virus: "It will be important to get answers quickly, to try to find out what works and what doesn't work. We think that randomized evidence is the best way to do that."

doi:10.1126/science.abb8497

Kai is a contributing correspondent for Science magazine based in Berlin, Germany. He is writing a book about the color blue, to be published this autumn.

Jon is a staff writer for Science.

More from News

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WHO launches global megatrial of the four most promising coronavirus treatments

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A drug combo already used against HIV. A malaria treatment first tested during World War II. A new antiviral whose promise against Ebola fizzled last year. Could any of these drugs hold the key to saving coronavirus disease 2019 (COVID-19) patients from serious harm or death?

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As the rapid spread of COVID-19 progresses, there is a race to find a cure. The FDA recently authorized the usage of the anti-malarial drug, hydroxychloroquine to treat patients who have contracted the virus. 6,227 physicians out of 30 countries have rated hydroxychloroquine the most effective drug in treating the virus. However, as of today there still is no evidence that any form of medicine is the cure to COVID-19 according to the World Health Organization.

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An international poll of thousands of doctors rated the Trump-touted anti-malarial drug hydroxychloroquine as the best treatment for the novel coronavirus.

Of the 6,227 physicians surveyed in 30 countries, 37 percent rated hydroxychloroquine as the "most effective therapy" for combating the potentially deadly illness, according to the results released Thursday.

The survey, conducted by the global health care polling company Sermo, also found that 23 percent of medical professionals had prescribed the drug in the US - far less than other countries.

"Outside the US, hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the US it was most commonly used for high risk diagnosed patients," the survey found.

The medicine was most widely used in Spain, where 72 percent of physicians said they had prescribed it.

A debate about hydroxychloroquine was sparked two weeks ago after President Trump touted the drug as a possible "game-changer" in the fight against the COVID-19 pandemic, prompting critics to accuse him of peddling unproven, untested remedies.

To date, "there is no evidence" that any medicine "can prevent or cure the disease," according to the World Health Organization.

But Sermo CEO Peter Kirk called the polling results a "treasure trove of global insights for policymakers."

"Physicians should have more of a voice in how we deal with this pandemic and be able to quickly share information with one another and the world," he said in a press release.

The 30 countries where doctors were surveyed included ones in Europe, South America, and Australia - and no incentives were provided to participate, the company said.

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Hydroxychloroquine rated 'most effective' coronavirus treatment, poll of doctors finds

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An international poll of thousands of doctors rated the Trump-touted anti-malarial drug hydroxychloroquine as the best treatment for the novel coronavirus. Of the 6,227 physicians surveyed in 30 countries, 37 percent rated hydroxychloroquine as the "most effective therapy" for combating the potentially deadly illness, according to the results released Thursday.

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Due to how recent this virus had started from, the FDA has not approved any cures or treatments for COVID-19. However, many clinical trials have been started to find out possible treatments for the virus, for example, Chloroquine, which is actually the drug that fights malaria. The alternative, hydroxychloroquine, has been shown to treat autoimmune diseases, and a way to stop the disease is by having a strong immune system to fight it. Dr. William Schaffner, an infectious disease expert at Vanderbilt University, stated that they have already begun using hydroxychloroquine, so we will have to see the results of the trials and hope that it gets us one step closer to solving this problem.

Source: https://www.nytimes.com/2020/03/22/science/coronavirus-drugs-chloroquine.html

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There is no cure for COVID-19 at the moment since it is a new strand that emerged. Nonetheless, the FDA has done a lot in response to the pandemic. As of now, the FDA is facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary. The FDA continues to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate.

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The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

As part of those efforts, President Trump has directed the FDA to continue its work with the public and private sector to ensure the availability of potentially safe and effective life-saving drugs to patients who are in desperate need, including those infected with COVID-19.

The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.

"President Trump's aggressive response and bold actions to keep Americans safe from COVID-19 bought us precious time to advance therapeutics and other necessary tools," said HHS Secretary Alex Azar. "Today's actions show that HHS and the United States are leading the world in these efforts. Disseminating information about promising off-label uses of drugs we already have, investigating their effectiveness, and pursuing other therapeutics will help give American healthcare providers the tools they need to save lives. As we have always seen when America has faced a serious threat, American industry, academic institutions and government are coming together to deliver us what we need to win."

The FDA wants to assure the American public that the agency continues to work with partners across the U.S. government and regulated industry to expedite the development and availability of critical medical products to prevent and treat this novel virus, including repurposing existing therapies that may help treat patients with COVID-19.

"As is true for most medical situations, the great American innovators in academia and industry have engaged with us about treatment options. We are extremely encouraged by the interest and promise in the development of the COVID-19-related therapies. We understand and recognize the urgency with which we are all seeking prevention and treatment options for COVID-19. FDA staff are working expeditiously on that front" said FDA Commissioner Stephen Hahn, M.D. "We also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments. At the same time, we will engage with domestic manufacturers to ramp up production of this product to mitigate any potential supply chain pressures. If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it. We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus."

While there are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19, there are several FDA-approved treatments that may help ease the symptoms from a supportive care perspective.

The FDA is working closely with innovators in their work to expedite these efforts, including leveraging scientific information about the virus and trials currently being conducted in other countries such as China, Japan, South Korea and Italy as well as in the U.S.

Quickly after the emergence of this virus, the FDA began working directly with partners and innovators to foster the development of medical countermeasures against COVID-19, and we are continuing to provide regulatory flexibility, advice, guidance, and technical assistance. The FDA continues to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate. The FDA is able to, and has been, turning around requests very quickly to assist in initiating clinical trials.

For example, last month, the National Institutes of Health (NIH) began a randomized controlled trial for the treatment of COVID-19 patients with the investigational antiviral drug remdesivir. The FDA has been working with the drug sponsor, Gilead Sciences Inc., to find multiple pathways to both study the drug under the FDA's investigational new drug requirements, and thus collect helpful data about the efficacy of the drug, as well as provide the drug to patients under emergency use. The FDA is committed to continuing to make use of its expanded access program to allow the emergency use of this product for those patients, when appropriate. To date, the agency has already granted about 250 patients access to this product. The data collected from the expanded access program may contribute to the agency's understanding of the drug, but controlled clinical trials are needed to determine if it safe and effective for the treatment of COVID-19 infection.

The FDA's efforts to facilitate the development of these therapies are squarely focused on ensuring these medical countermeasures meet the agency's world-respected gold standard, relying on data from adequate and well-controlled trials to most efficiently determine if an experimental treatment can safely and effectively benefit patients.

Innovators are looking at products in a variety of areas, including the assessment of antiviral drugs that might treat the specific virus, as well as host targets, such as interleukin-6 (IL-6) receptor inhibitors that may be helpful in reducing lung inflammation and improving lung function in COVID-19 patients, thereby potentially slowing the progression of severe respiratory symptoms. Regeneron Pharmaceuticals Inc. has announced the initiation of a randomized controlled clinical trial of sarilumab, an antibody to the IL-6 receptor, to assess whether the modification of the inflammatory response by this treatment provides benefit to COVID-19 patients.

There's also interest in evaluating whether therapies, such as convalescent plasma and hyperimmune globulin, antibody-rich blood products that are taken from blood donated by people who have recovered from the virus, could shorten the length, or lessen the severity, of the illness. The FDA is taking the lead on an urgent cross-government approach to facilitate the development of all of these products. Facilitating the ultimate widespread use and availability of safe and effective medical countermeasures is critical for a number of reasons, including that reducing the severity and duration of respiratory or other symptoms through medical treatments could help lessen the burden on medical personnel, equipment, and facilities.

At the same time, the FDA will continue work to facilitate the development of treatment options in the near-term, the agency is also working with interagency partners, product developers, and international public health organizations to expedite the development of vaccines to the greatest extent possible. In fact, earlier this week, NIH announced the start of a Phase 1 clinical trial in Seattle in 45 healthy adult volunteers to test the safety of an investigational vaccine designed to protect against COVID-19 infection. The FDA intends to use all of the regulatory flexibility granted to it by Congress to ensure the most efficient and timely development of vaccines to fight COVID-19.

As agency staff work around the clock to facilitate prevention and treatment options, it's extremely important for everyone to know that people may try to make claims about products that are not approved - and don't have data supporting efficacy - in preventing, treating or diagnosing COVID-19. The FDA is closely monitoring the market to combat these products with fraudulent claims. It is unacceptable that anyone would take advantage of Americans during this public health crisis, and the FDA wants to make sure everyone knows what legitimate products are being developed.

The FDA remains steadfast in helping to foster the development of safe and effective medical countermeasures and ensuring they are available as quickly as possible to protect public health and safeguarding Americans from fraudulent products claiming to prevent, treat, or diagnose COVID-19 as part of the agency's around-the-clock response to this outbreak.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments

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The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

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Currenty there are no treatments for covid-19 but there are several drugs that are being tested to see if they are against the covid 19. It is hard to develop a tratment because there are certain drugs that just attack a part of the virus. Something that can help if you have the virus is resting, staying hydrated and taking acetamino

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Treatments for COVID-19 - Harvard Health

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What helps, what doesn't, and what's in the pipeline Most people who become ill with COVID-19 will be able to recover at home. Some of the same things you do to feel better if you have the flu - getting enough rest, staying well hydrated, and taking medications ...

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COVD-19 is an emerging and rapidly evolving situation, thus there are several clinical trials that have been conducted as an experimental treatment to COVD-19. One such clinical trial, that began February 25, 2020 went underway at the University of Nebraska Medical Center (UNMC) in Omaha. Sponsored by the National Institute of Allergy and Infectious Diseases (NAID), part of the National Institute of Health (NIH), was the first clinical trial in the United States to evaluate an experimental treatment to COVD-19. The first person to participate in the trial is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan and volunteered to participate in the study. Though there are no specific therapeutics approved by the Food and Drug Administration (FDA) to treat people with COVID-19, the antiviral treatment, Remdesivir seems to be a promising candidate in the experimental treatment of COVD-19. Remdesivir, developed by Gilead Sciences Inc., was previously tested humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome, otherwise known as (MERS) as well as the Severe Acute Respiratory Syndrome (SARS), which are caused by other coronaviruses. Clinical trials of remdesivir are also ongoing in China, the U.K and other places around the world. “There’s only one drug right now that we think may have real efficacy,” Bruce Aylward of the World Health Organization said last month. “And that’s remdesivir." If this is indeed, true, then we may see this antiviral treatment manufactured and distributed around the world.

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Most people who become ill with COVID-19 will be able to recover at home. No specific treatments for COVID-19 exist right now. But some of the same things you do to feel better if you have the flu — getting enough rest, staying well hydrated, and taking medications to relieve fever and aches and pains — also help with COVID-19.

In the meantime, scientists are working hard to develop effective treatments. Therapies that are under investigation include drugs that have been used to treat malaria and autoimmune diseases; antiviral drugs that were developed for other viruses, and antibodies from people who have recovered from COVID-19.
Currently there is no specific antiviral treatment for COVID-19. However, similar to treatment of any viral infection, these measures can help:

While you don't need to stay in bed, you should get plenty of rest.

Stay well hydrated.

To reduce fever and ease aches and pains, take acetaminophen. Be sure to follow directions. If you are taking any combination cold or flu medicine, keep track of all the ingredients and the doses. For acetaminophen, the total daily dose from all products should not exceed 3,000 milligrams.

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Treatments for COVID-19 - Harvard Health

# data[].attributes.attachment_link.description
What helps, what doesn't, and what's in the pipeline Most people who become ill with COVID-19 will be able to recover at home. Some of the same things you do to feel better if you have the flu - getting enough rest, staying well hydrated, and taking medications ...

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There are no FDA-approved drugs for treating patients with corona virus. However there are drugs approved to treat other diseases that might help corona virus patients. Researchers are constantly studying them in many clinical trials around the globe. Currently the only two drugs that are being tested to fight the corona virus are chloroquine and hydroxychloroquine. Many are concerned that the virus will become worse but researchers are still fighting to find a cure.

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According to the Centers for Disease Control and Prevention, there are currently no FDA-approved drugs for treating patients with COVID-19. There are, however, drugs approved to treat other diseases that might help coronavirus patients. Researchers are studying them in hundreds of clinical trials around the globe.

But hospitals are faced with a tough decision right now: when a patient has COVID-19, which unproven drugs fall into the "might help, won't hurt" category?

"It's a very difficult position to be in, because we want to be judicious in how we treat patients with COVID-19," says Daniel Kuritzkes, chief of the division of infectious diseases at Brigham and Women's hospital. "We don't want to be throwing the kitchen sink at folks without any basis."

Gyongyi Szabo, chief academic officer at Beth Israel Deaconess Medical Center, also said it well: "The last thing we want to do is expose patients who have COVID-19 to interventions that could make them worse."

Here are five things to know:
1. The "Malaria D rug" - Hydroxychloroquine
Hydroxychloroquine is related to a nearly-century-old malaria drug called chloroquine, which President Trump recently touted.

Hydroxychloroquine may have some anti-viral effects and is known to reduce inflammation. This is good, because it appears that an over-zealous inflammatory response is what causes so much damage to the lungs of COVID-19 patients. The FDA has approved the drug for treating lupus and rheumatoid arthritis, but - though clinical trials are underway - there's no rigorous, scientific data showing that hydroxychloroquine is effective against the coronavirus.

Despite this, there's been a run on the drug across the country, including in Massachusetts. And some local hospitals - including Massachusetts General Hospital (MGH), Tufts Medical Center, Brigham and Women's and Boston Medical Center - are using it on some patients with COVID-19.

"There was some anecdotal clinical data at places that had already had a fair number of COVID cases. It was a drug we could get access to, and although no drug is completely safe, it's a relatively safe drug," said Tamar Barlam, chief of the infectious disease section at Boston Medical Center. "This is very anecdotal data, but this is what we have, unfortunately, right now."

Barlam said doctors at BMC are reserving the drug for patients hospitalized with COVID-19, whose oxygen levels are starting to dip. The drug can have side effects, like retina damage and irregular heartbeat, as well as dangerous interactions with other medications. And mistakes can be fatal: an Arizona man recently died from taking non-pharmaceutical chloroquine phosphate, a version of the drug used to treat diseases in aquarium fish. So doctors ask that you leave the dosing to them.
2. An Arthritis Drug That Might Help: Sarilumab
"The vast majority of people who get COVID-19 are going to do fine. Self-medicating is a big mistake," said Brigham and Women's Kuritzkes. "If they become sick enough to need hospitalization, then they can be treated in a much more supervised manner."

Sarilumab, also known by its brand name Kevzara, is an antibody that may help suppress the runaway immune response that causes so much damage in patients with COVID-19. The FDA approved Sarilumab for treating rheumatoid arthritis in 2017. Again, there's no proof that the drug works against this coronavirus, but researchers recently launched clinical trials - including one at Tufts Medical Center - to see if it might help patients with COVID-19 (For updates on trials in Boston, check the National Institutes of Health's searchable database of all ongoing clinical trials).

The Tufts study will be open to adult patients who have "documented SARS-CoV-2 infection, pneumonia and need for additional oxygen," said Andreas Klein, associate chief of Hematology and Oncology at Tufts Medical Center and director of the Sarilumab trial. SARS-CoV-2 is the scientific name for the novel coronavirus.
3. An Anti-Viral Drug Made For Ebola: Remdesivir
Some patients in the study will receive a placebo, or dummy pill, which allows researchers to measure whether the experimental drug is more effective than no treatment at all. "It is critical to include a placebo at this time because we don't really know that this strategy is helping and it could be making people worse," said Klein. "The study is very carefully monitored for both safety and effectiveness."

Scientists at GileadSciences, Inc. developed Remdesivir during the 2014-2016 Ebola outbreak, but other drugs outperformed it. However, animal studies showed that the drug could be effective against other coronavirus infections, like SARS and MERS.

Remdesivir interferes with how the viruses replicate inside cells, so it may be able to slow or stop the spread of SARS-CoV-2 in the body. The key word here is "maybe," because there is no scientific proof that the drug works against this coronavirus.

Researchers are testing the drug in clinical trials all over the world, including trials at Beth Israel, Brigham and Women's and MGH. Scientists probably won't have final results for a couple months at least, but the study's "monitoring board" looks at data as it comes in. If Remdesivir appears to be really effective - or really dangerous - the monitoring board can stop the trials.

Gileadwas also providing "compassionate use" doses of Remdesivir for patients very sick with COVID-19. But demand got so high that the companysharply curtailed that program in mid-March. There is still some Remdesivir available for compassionate use, but now the primary way to get it is through a clinical trial.
4. New Drugs On The (Distant) Horizon
One important thing to remember: Remdesivir is an antivirial medication - if it works, it slows down or stops the spread of the virus in the body. That may turn out to be less helpful for patients who are already very sick, because the virus has already spread and triggered runaway inflammation.

There are companies all over the world rushing to find new treatments for COVID-19, including Massachusetts biotech firms like Biogen. But new drugs will have to go through safety testing, and that means it will take months or years before they get to patients.
5. Other Treatments You May Have Heard About
Doctors at local hospitals don't have that kind of time. That's why they're looking through the antivirial and anti-inflammatory drugs that they already have to see what might work. There's also been some talk about using antibodies from the blood of patients who have recovered from COVID-19 - the so-called "convalescent serum" - but that research is in its early stages, and none of the Boston hospitals contacted are currently trying this.

Some physicians are considering the use of the cholesterol-lowering drugs called statins, since they also have an anti-inflammatory effect. Again, there's no proof that they work for COVID-19, and statins can have serious side effects and drug interactions.

You may also have heard about Azithromycin, an antibiotic that may help reduce inflammation. In one small study, patients who were given the antibiotic in combination with hydroxychloroquine had less detectable virus in their upper respiratory tract. However, the side effects of the two drugs together -- dangerous irregular heartbeats-- are so severe that doctors are reluctant to use them.

"It's pretty controversial," said DebraPoutsiaka, an infectious disease physician at Tufts. "The data is very thin, and there are real safety concerns."

Some other stuff that doesn't work: the anti-HIV drugs lopinavir and ritonavir. Doctors in China tested them in a recent clinical trial on COVID-19 patients with pneumonia and found no benefit.

Corticosteroids: also not so helpful. While they can help reduce inflammation, they "inactivate large swaths of the immune response, ultimately compromising the entire fight," said Tufts' Andreas Klein.

The best medicine, said Poutsiaka, may be "NPI," or non-pharmacological interventions.

"The best way to beat this virus is what everybody's talking about - social distancing, wash your hands, don't touch your face, don't go to work or be around people who are ill, and if you see somebody who's sick, stay away from them," she said.

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With No Proven Drug Therapies For COVID-19, Here's What Boston Hospitals Are Trying

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According to the Centers for Disease Control and Prevention, there are currently no FDA-approved drugs for treating patients with COVID-19. There are, however, drugs approved to treat other diseases that might help coronavirus patients. Researchers are studying them in hundreds of clinical trials around the globe.

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Several in vitro studies report antiviral activity of chloroquine and hydroxychloroquine against SARS-CoV-2. In vivo data, although promising, is currently limited to one study with considerable limitations. On the basis of the weak evidence available to date, treatment guidelines have already incorporated the usage of chloroquine/hydroxychloroquine for certain patients with COVID-19.
Chloroquine (CQ) was first used as prophylaxis and treatment for malaria. Hydroxychloroquine (HCQ) is a more soluble and less toxic metabolite of chloroquine, which causes less side effects and is, therefore, safer. The empirical evidence for the effectiveness of CQ/HCQ in COVID-19 is currently very limited. First clinical results were reported in a news briefing by the Chinese government in February 2020, revealing that the treatment of over 100 patients with chloroquine phosphate in China had resulted in significant improvements of pneumonia and lung imaging, with reductions in the duration of illness. Source: https://www.cebm.net/covid-19/chloroquine-and-hydroxychloroquine-current-evidence-for-their-effectiveness-in-treating-covid-19/

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UPDATE: A Covid-19 case correlation between malarial and non-malarial countries has been plotted by Dr. Roy Spencer, and the results are stunning - see below.

Encouraging news: three new medical studies show a commonly available anti-malaria drug known as chloroquine aka chloroquine phosphate is showing strong results against COVID-19 infections in both China and South Korea. Excerpts from three studies, including one published in Nature are below.

quinine word in a dictionary. quinine concept.

An Effective Treatment for Coronavirus (COVID-19)
Presented by: James M. Todaro, MD and Gregory J. Rigano, Esq.
In consultation with Stanford University School of Medicine, UAB School of Medicine and National Academy of Sciences researchers. SPANISH: https://docs.google.com/document/d/e/2PACX-1vR1adodKPhWalV9djnerI2x_v1LGgGyhZZxpl0O5r-ZNyDdagqFq1rTCxXBqaeicfxgvypDOqKCZVyV/pub
Translation by: Celia Martínez-Aceves ( Yale B.S. Candidate 2021), Martín Martínez ( MIT B.S. 2017)
Summary
Recent guidelines from South Korea and China report that chloroquine is an effective antiviral therapeutic treatment against Coronavirus Disease 2019. Use of chloroquine (tablets) is showing favorable outcomes in humans infected with Coronavirus including faster time to recovery and shorter hospital stay. US CDC research shows that chloroquine also has strong potential as a prophylactic (preventative) measure against coronavirus in the lab, while we wait for a vaccine to be developed. Chloroquine is an inexpensive, globally available drug that has been in widespread human use since 1945 against malaria, autoimmune and various other conditions.

Chloroquine: C₁₈H₂₆ClN₃ Background
The U.S. CDC and World Health Organization have not published treatment measures against Coronavirus disease 2019 ("COVID-19"). Medical centers are starting to have issues with traditional protocols. Treatments, and ideally a preventative measure, are needed. South Korea and China have had significantly more exposure and time to analyze diagnostic, treatment and preventative options. The U.S., Europe and the rest of the world can learn from their experience. According to former FDA commissioner, board member of Pfizer and Illumina, Scott Gotlieb MD, the world can learn the most about COVID-19 by paying closest attention to the response of countries that have had significant exposure to COVID-19 before the U.S. and Europe.

As per the U.S. CDC, "Chloroquine (also known as chloroquine phosphate) is an antimalarial medicine... Chloroquine is available in the United States by prescription only... Chloroquine can be prescribed for either prevention or treatment of malaria. Chloroquine can be prescribed to adults and children of all ages. It can also be safely taken by pregnant women and nursing mothers."

CDC research also shows that "chloroquine can affect virus infection in many ways, and the antiviral effect depends in part on the extent to which the virus utilizes endosomes for entry. Chloroquine has been widely used to treat human diseases, such as malaria, amoebiosis, HIV, and autoimmune diseases, without significant detrimental side effects."

The treatment guidelines of both South Korea and China against COVID-19 are generally consistent, outlining chloroquine as an effective treatment.

Specifically, according to the Korea Biomedical Review, in February 2020 in South Korea, the COVID-19 Central Clinical Task Force, composed of physicians and experts treating patients agreed upon treatment principles for patients with COVID-19. In China, the General Office of the National Health Commission, General Office of the State Administration of Traditional Chinese Medicine as well as a Multi-Center Collaborative Group of Guangdong Provincial Department of Science and Technology and Guangdong Provincial Health Comp and the China National Center for Biotechnology Development have established effective treatment measures based on human studies.

According to their research (reported in Clinical Trials Arena),

"Data from the drug's [chloroquine] studies showed 'certain curative effect' with 'fairly good efficacy' ... patients treated with chloroquine demonstrated a better drop in fever, improvement of lung CT images, and required a shorter time to recover compared to parallel groups. The percentage of patients with negative viral nucleic acid tests was also higher with the anti-malarial drug... Chloroquine has so far shown no obvious serious adverse reactions in more than 100 participants in the trials... Chloroquine was selected after several screening rounds of thousands of existing drugs. Chloroquine is undergoing further trials in more than ten hospitals in Beijing, Guangdong province and Hunnan province."

...
Chloroquine as a prophylactic (preventative) measure against COVID-19
According to research by the US CDC, chloroquine has strong antiviral effects on SARS coronavirus, both prophylactically and therapeutically. SARS coronavirus has significant similarities to COVID-19. Specifically, the CDC research was completed in primate cells using chloroquine's well known function of elevating endosomal pH. The results show that "We have identified chloroquine as an effective antiviral agent for SARS-CoV in cell culture conditions, as evidenced by its inhibitory effect when the drug was added prior to infection or after the initiation and establishment of infection. The fact that chloroquine exerts an antiviral effect during pre- and post-infection conditions suggest that it is likely to have both prophylactic and therapeutic advantages."

The study shows that chloroquine is effective in preventing SARS-CoV infection in cell culture if the drug is added to the cells 24 h prior to infection.

FIGURE 1

Prophylactic effect of chloroquine. Vero E6 cells pre-treated with chloroquine for 20 hrs. Chloroquine-containing media were removed and the cells were washed with phosphate buffered saline before they were infected with SARS-CoV (0.5 multiplicity of infection) for 1 h in the absence of chloroquine. Virus was then removed and the cells were maintained in Opti-MEM (Invitrogen) for 16-18 h in the absence of chloroquine. SARS-CoV antigens were stained with virus-specific HMAF, followed by FITC-conjugated secondary antibodies. (A) The concentration of chloroquine used is indicated on the top of each panel. (B) SARS-CoV antigen-positive cells at three random locations were captured by using a digital camera, the number of antigen-positive cells was determined, and the average inhibition was calculated. Percent inhibition was obtained by considering the untreated control as 0% inhibition. The vertical bars represent the range of SEM.

...

In addition, the study also shows that chloroquine was very effective even when the drug was added 3-5 h after infection, suggesting an antiviral effect even after the establishment of infection.

...
The UK has banned the export of Chloroquine
As of February 26, 2020, the UK government has added chloroquine to the list of medicines that cannot be parallel exported from the UK. Chloroquine was never on this list before. This likely happened because of the growing body of evidence of chloroquine's effectiveness against coronavirus.
China prioritizes internal use of Active Pharmaceutical Ingredients (APIs) including Chloroquine
In early February, Chongqing Kangle Pharmaceutical was requested by the Ministry of Industry and Information Technology, Consumption Division to promptly increase the manufacturing and production of the active pharmaceutical ingredients chloroquine phosphate despite slowed production during the Chinese New Year.

...
Conclusion
Chloroquine can both both prevent and treat malaria. Chloroquine can prevent and treat coronavirus in primate cells (Figure 1 and Figure 2). According to South Korean and China human treatment guidelines, chloroquine is effective in treating COVID-19. Given chloroquine's human safety profile and existence, it can be implemented today in the U.S., Europe and the rest of the world. Medical doctors may be reluctant to prescribe chloroquine to treat COVID-19 since it is not FDA approved for this use. The United States of America and other countries should immediately authorize and indemnify medical doctors for prescribing chloroquine to treat COVID-19. We must explore whether chloroquine can safely serve as a preventative measure prior to infection of COVID-19 to stop further spread of this highly contagious virus.

Full study available here

Then there's this second study:

Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies Jianjun Gao, Zhenxue Tian, Xu Yang

Abstract

The coronavirus disease 2019 (COVID-19) virus is spreading rapidly, and scientists are endeavoring to discover drugs for its efficacious treatment in China. Chloroquine phosphate, an old drug for treatment of malaria, is shown to have apparent efficacy and acceptable safety against COVID-19 associated pneumonia in multicenter clinical trials conducted in China. The drug is recommended to be included in the next version of the Guidelines for the Prevention, Diagnosis, and Treatment of Pneumonia Caused by COVID-19 issued by the National Health Commission of the People's Republic of China for treatment of COVID-19 infection in larger populations in the future.
https://www.jstage.jst.go.jp/article/bst/14/1/14_2020.01047/_article
Finally, there's a new study in the prestigious journal Nature:

Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro

Excerpt:

Chloroquine, a widely-used anti-malarial and autoimmune disease drug, has recently been reported as a potential broad-spectrum antiviral drug. Chloroquine is known to block virus infection by increasing endosomal pH required for virus/cell fusion, as well as interfering with the glycosylation of cellular receptors of SARS-CoV. Our time-of-addition assay demonstrated that chloroquine functioned at both entry, and at post-entry stages of the 2019-nCoV infection in Vero E6 cells (Fig. 1c, d). Besides its antiviral activity, chloroquine has an immune-modulating activity, which may synergistically enhance its antiviral effect in vivo. Chloroquine is widely distributed in the whole body, including lung, after oral administration. The EC ₉₀ value of chloroquine against the 2019-nCoV in Vero E6 cells was 6.90 μM, which can be clinically achievable as demonstrated in the plasma of rheumatoid arthritis patients who received 500 mg administration. Chloroquine is a cheap and a safe drug that has been used for more than 70 years and, therefore, it is potentially clinically applicable against the 2019-nCoV.

Our findings reveal that remdesivir and chloroquine are highly effective in the control of 2019-nCoV infection in vitro. Since these compounds have been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease.

Study: https://www.nature.com/articles/s41422-020-0282-0?fbclid=IwAR2JbbZU_Hl7uLjuOTDhrNnmczzyEFvnIhY8QHv9ghY5fYBvX0IsmnhD07w

A commonly available over-the-counter quinine source exists in Margosa Tree Bark and Cinchona succirubra, Peruvian Bark

Tablets of bark extract are widely available in tablet form, from many sources, including Amazon.com .

There's also quinine in Tonic Water, which is available just about anywhere at any grocery or liquor store and also at Amazon:

Tonic water is a soft drink containing quinine, which gives it a bitter taste. Quinine is a common treatment for malaria. Quinine comes from the bark of the cinchona tree.
UPDATE: From Facebook, Dr. Roy Spencer adds this new information.- Anthony
On the subject of using antimalarial drugs for COVID-19 treatment, I've compared COVID-19 cases versus malaria incidence by country....

This is amazing. I downloaded all of the data for 234 countries, incidence of total COVID-19 cases (as of 3/17/2020) versus the incidence of malaria in those countries (various sources, kinda messy matching everything up in Excel).

RESULTS, Multi-country average malaria cases per thousand, COVID-19 cases per million, in three classes of countries based on malaria incidence:

Top 40 Malaria countries: 212 malaria = 0.2 COVID-19;

Next 40 Malaria countries: 7.3 malaria = 10.1 COVID-19

Remaining (81-234) countries: 0.00 malaria = 68.7 COVID-19

Again, the units are Malaria cases per thousand "population at risk", and COVID-19 cases per million total population.

In all my years of data analysis I have never seen such a stark and strong relationship: Countries with malaria basically have no COVID-19 cases (at least not yet).

Additional support for antimalarial drugs for COVID-19 treatment comes from this investigation linked below.

The map says it all: COVID-19 is where Malaria is not.

https://docs.google.com/document/d/12YDytbAsZaruGlhFO7eTTgxSH_BuxJtwFmbhqpkPPSk/mobilebasic?fbclid=IwAR2wXhG5woobpV5DAuHxnf7YOxalQiCkPMX-rUL2z6SIa0AJGovbJ9ATq7A

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An effective treatment for #Coronavirus #COVID-19 has been found in a common anti-malarial drug

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UPDATE: A Covid-19 case correlation between malarial and non-malarial countries has been plotted by Dr. Roy Spencer, and the results are stunning - see below. Encouraging news: three new medical studies show a commonly available anti-malaria drug known as chloroquine aka chloroquine phosphate is showing strong results against COVID-19 infections in both China and South Korea.

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As of now, chloroquine and hydroxychloroquine are just two drugs being tested for their effectiveness in fighting COVID-19 (coronavirus). Chloroquine is known as treatment for malaria (a disease caused by parasite bites), and hydroxychloroquine is the safer version of chloroquine being that it is less toxic. Both drugs have been used as treatment for various conditions/diseases such as HIV/AIDS, rheumatoid arthritis, and forms of lupus. Because of its success in treating other diseases, it is being used in clinical trials to determine whether it can be used to fight the ongoing COVID-19 pandemic. According to cebm.net, as of now, the effect of the drugs is limited.

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March 25, 2020
Kerstin Frie and Kome Gbinigie
Oxford COVID-19 Evidence Service Team
Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences
University of Oxford
Correspondence to oghenekome.gbinigie@phc.ox.ac.uk
Lay Summary by Mandy Payne, Health Watch

VERDICT
Several in vitro studies report antiviral activity of chloroquine and hydroxychloroquine against SARS-CoV-2. In vivo data, although promising, is currently limited to one study with considerable limitations. On the basis of the weak evidence available to date, treatment guidelines have already incorporated the usage of chloroquine/hydroxychloroquine for certain patients with COVID-19.

Further research should address the optimal dose and duration of treatment, and explore side effects and long-term outcomes.

There is a higher risk of side effects in the presence of renal and liver impairment, and there have been isolated reports of COVID-19 disease-causing renal and hepatic injury.

Over twenty in vivo clinical trials have already been registered to test the use of chloroquine and hydroxychloroquine for the treatment of COVID-19.

Contraindications for the use of these drugs must be checked for each individual before treatment. Empirical evidence suggests that hydroxychloroquine has a better safety profile, and it might therefore be preferable to focus research efforts on this less toxic metabolite.

BACKGROUND
Chloroquine (CQ) was first used as prophylaxis and treatment for malaria. Hydroxychloroquine (HCQ) is a more soluble and less toxic metabolite of chloroquine, which causes less side effects and is, therefore, safer (1-3).
More recently, CQ/HCQ has been used to manage conditions such as systemic lupus erythematosus and rheumatoid arthritis. CQ/HCQ has been used in the treatment of HIV with mixed results (4). The ability of CQ/HCQ to inhibit certain coronaviruses, such as SARS-CoV-1, has been explored with promising results (5, 6). Both drugs are affordable and widely available internationally. With decades of experience administering these drugs, their safety profiles are well-established. It is likely to take many months for novel, specific treatments of COVID-19 to become available. As a result, there has been growing interest in the use of CQ and HCQ as potential treatments in the interim.
Results from In Vitro and In Vivo Research In Vitro Studies
There is preliminary in vitro evidence of the ability of CQ and HCQ to inhibit SARS-CoV-2 activity. Liu et al (7) found a similar 50% cytotoxic concentration (CC50 - the concentration which results in 50% cell death) for the two drugs, however, the 50% maximal effective concentration (EC50 - the concentration at which viral RNA increase is inhibited by 50%) was lower for CQ than HCQ, irrespective of the multiplicity of infection (MOI - the ratio of virions to host cells) (7).

By contrast, Yao et al (1) found that HCQ was more potent against SARS-CoV-2 than CQ in vitro (EC50 of 0.72 μM and 5.47 μM, respectively. MOI = 0.01). Wang et al reported in vitro antiviral activity of CQ, with an EC50 of 1.13μM and CC50 >100μM at an MOI of 0.05, and with high selectivity for SARS-CoV-2 rather than host cells (8).
In Vivo Clinical Trials
The empirical evidence for the effectiveness of CQ/HCQ in COVID-19 is currently very limited. First clinical results were reported in a news briefing by the Chinese government in February 2020, revealing that the treatment of over 100 patients with chloroquine phosphate in China had resulted in significant improvements of pneumonia and lung imaging, with reductions in the duration of illness (9). No adverse events were reported. It appears that these findings were a result of combining data from several ongoing trials using a variety of study designs. No empirical data supporting these findings have been published so far.

On the 17th of March 2020, the first clinical trial data were published by Gautret and colleagues in France (2). The researchers conducted an open-label non-randomised controlled trial with 36 patients diagnosed with SARS-CoV-2. Six of these patients were asymptomatic, 22 had upper respiratory tract infection symptoms and eight had lower respiratory tract infection symptoms. Twenty patients were assigned to the treatment group, and received HCQ 200mg three times a day for ten days. The control group received usual care. Six of the patients in the treatment group were also prescribed azithromycin to prevent bacterial superinfection.

The main outcome of the trial was SARS-CoV-2 carriage at Day 6, tested using PCR of SARS-CoV-2 RNA from nasopharyngeal swabs. The results showed that patients in the treatment group were significantly more likely to test negative for the virus on Day 6 than patients in the control group (70% vs 12.5% virologically cured, p<0.001). Moreover, all of the six patients who were treated with a combination of HCQ and azithromycin tested negative on Day 6. The authors argue that this finding speaks to the effectiveness of HCQ and a potential synergistic effect of its combined treatment with azithromycin.

Following the promising results of these first clinical trials, official guidelines recommending the treatment of COVID-19 using CQ/HCQ were published. The National Health Commission of the People's Republic of China published their recommendation mid-February, suggesting to treat patients with 500mg chloroquine phosphate (300mg for CQ) twice per day, for a maximum of 10 days (10). In Italy, the L. Spallanzani National Institute for the Infectious Disease published their recommendations for treatment on the 17th of March, which included the provision of 400mg of HCQ per day or 500mg CQ per day, in combination with another antiviral agent (11).
While the results of these clinical trials sound promising, there are several limitations.
No data from the Chinese research have been published as yet and the results and conclusions can therefore not be peer-reviewed. The trial by Gautret and colleagues also has some limitations. The authors state that an additional six patients were recruited to the trial, but were lost to follow-up for various reasons. The authors excluded these six patients and did not perform intention-to-treat analysis, which may have introduced bias (12). Moreover, the researchers did not recruit the 48 patients necessary to achieve 85% power, as per their own calculations. With a sample size of 36 the trial was therefore underpowered, which may cause exaggeration of effect sizes and false-positive results (13). With viral PCR status at Day 6 as the primary outcome, the trial lacks medium and long-term follow-up data. The authors report that one patient tested negative for the virus on Day 6, but subsequently tested positive on Day 8. Such recurrences of positive test results demonstrate that long-term data is necessary to properly assess whether CQ/HCQ are effective treatments. Finally, the trial did not randomise patients to the control and treatment group, thus potentially introducing allocation bias. Given these considerable limitations of the current evidence, further clinical trials are urgently needed so that we can better understand the effectiveness of CQ and HCQ for the treatment of COVID-19. Fortunately, more than twenty clinical trials are already registered to this purpose (14). The trials employ a variety of study designs (including open-label randomised, open-label non-randomised, and single-blinded randomised), exclusion criteria, and treatment approaches (only CQ/only HCQ/either in combination with another drug) (15). It remains to see whether the results of these trials support further usage of CQ/HCQ for the treatment of COVID-19.
Biological Mechanism of Chloroquine
A number of potential mechanisms of action of CQ/HCQ against SARS-CoV-2 have been postulated. The virus is believed to enter cells by binding to a cell surface enzyme called angiotensin-converting enzyme 2 (ACE2) (16). ACE2 expression is also believed to be upregulated by infection with SARS-CoV-2 (17). Chloroquine may reduce glycosylation of ACE2, thereby preventing COVID-19 from effectively binding to host cells (18). Furthermore, Savarino et al (19) hypothesise that CQ might block the production of pro-inflammatory cytokines (such as interleukin-6), thereby blocking the pathway that subsequently leads to acute respiratory distress syndrome (ARDS). Some viruses enter host cells through endocytosis; the virus is transported within the host cell in a cell-membrane derived vesicle called an endosome, within which the virus can replicate (19). When the endosome fuses with the acidic intracellular lysosome, this leads to rupture of the endosome with the release of the viral contents (19). Chloroquine has been found to accumulate in lysosomes, interfering with this process (20). Chloroquine is also believed to raise the pH level of the endosome, which may interfere with virus entry and/or exit from host cells (6).
Side Effects of Chloroquine
Both CQ and HCQ have been in clinical use for several years, thus their safety profile is well established (18). Gastrointestinal upset has been reported with HCQ intake (21). Retinal toxicity has been described with long-term use of CQ and HCQ (22, 23), and may also be related to over-dosage of these medications (23, 24). Isolated reports of cardiomyopathy (25) and heart rhythm disturbances (26) caused by treatment with CQ have been reported. Chloroquine should be avoided in patients with porphyria (27). Both CQ and HCQ are metabolised in the liver with renal excretion of some metabolites, hence they should be prescribed with care in people with liver or renal failure (27, 28). In a letter to the editor, Risambaf et al (27) raise concerns about reports of COVID-19 causing liver and renal impairment, which may increase the risk of toxicity of CQ/HCQ when it is used to treat COVID-19.

Disclaimer: the article has not been peer-reviewed; it should not replace individual clinical judgement and the sources cited should be checked. The views expressed in this commentary represent the views of the authors and not necessarily those of the host institution, the NHS, the NIHR, or the Department of Health and Social Care. The views are not a substitute for professional medical advice.

Kerstin Frie* is a postdoctoral researcher in the Health Behaviours team of the Nuffield Department of Primary Care Health Sciences, University of Oxford

Kome Gbinigie* is a General Practitioner and doctoral researcher based at the Nuffield Department of Primary Care Health Sciences, University of Oxford

*Co-first authors

SEARCH STRATEGY
We searched Pubmed and Google Scholar on 21st March 2020 using the search terms *chloroquine, coronavirus, SARS-Cov-2, 2019-NCov, and COVID-19. We screened titles and abstracts and included in vitro and in vivo studies of CQ/HCQ for the treatment of SARS-CoV-2. In addition, we included reviews of the existing literature on this topic. We provide a narrative summary of the current literature.
REFERENCES
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2) Gautret, P., Lagier, J.C., Parola, P., Meddeb, L., Mailhe, M., Doudier, B., Courjon, J., Giordanengo, V., Vieira, V.E., Dupont, H.T. and Honoré, S., 2020. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents, p.105949.
3) Sahraei, Z., Shabani, M., Shokouhi, S. and Saffaei, A., 2020. Aminoquinolines Against Coronavirus Disease 2019 (COVID-19): Chloroquine or Hydroxychloroquine. International Journal of Antimicrobial Agents, p.105945.
4) Chauhan, A. and Tikoo, A., 2015. The enigma of the clandestine association between chloroquine and HIV‐1 infection. HIV medicine, 16(10), pp.585-590.
5) Keyaerts, E., Li, S., Vijgen, L., Rysman, E., Verbeeck, J., Van Ranst, M. and Maes, P., 2009. Antiviral activity of chloroquine against human coronavirus OC43 infection in newborn mice. Antimicrobial agents and chemotherapy, 53(8), pp.3416-3421.
6) Vincent, M.J., Bergeron, E., Benjannet, S., Erickson, B.R., Rollin, P.E., Ksiazek, T.G., Seidah, N.G. and Nichol, S.T., 2005. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virology journal, 2(1), p.69.
7) Liu, J., Cao, R., Xu, M., Wang, X., Zhang, H., Hu, H., Li, Y., Hu, Z., Zhong, W. and Wang, M., 2020. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discovery, 6(1), pp.1-4.
8) Wang, M., Cao, R., Zhang, L., Yang, X., Liu, J., Xu, M., Shi, Z., Hu, Z., Zhong, W. and Xiao, G., 2020. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell research, 30(3), pp.269-271.
9) Gao, J., Tian, Z. and Yang, X., 2020. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. BioScience Trends.
10) Dong, L., Hu, S. and Gao, J., 2020. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discoveries & Therapeutics, 14(1), pp.58-60.
11) Nicastri, E., Petrosillo, N., Ippolito, G., D'Offizi, G., Marchioni, L., Bartoli, T.A., Lepore, L., Mondi, A., Murachelli, S. and Antinori, A., 2020. National Institute for the Infectious Diseases "L. Spallanzani" IRCCS. Recommendations for COVID-19 Clinical Management. Infectious Disease Reports, 12(1).
12) Ranganathan, P., Pramesh, C.S. and Aggarwal, R., 2016. Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis. Perspectives in clinical research, 7(3), p.144.
13) Dumas-Mallet, E., Button, K.S., Boraud, T., Gonon, F. and Munafò, M.R., 2017. Low statistical power in biomedical science: a review of three human research domains. Royal Society open science, 4(2), p.160254.
14) Aronson, J., Ferner, R., DeVito, N., Heneghan, C., 2020. COVID-19 trials registered up to 8 March 2020-an analysis of 382 studies. Retrieved from: https://www.cebm.net/oxford-covid-19/covid-19-registered-trials-and-analysis/
15) Chinese Clinical Trial Registry. https://tinyurl.com/tugmtze (accessed March 23, 2020).
16) Zhou, P., Yang, X.L., Wang, X.G., Hu, B., Zhang, L., Zhang, W., Si, H.R., Zhu, Y., Li, B., Huang, C.L. and Chen, H.D., 2020. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature, pp.1-4.
17) Wang, P.H., 2020. Increasing Host Cellular Receptor-Angiotensin-Converting Enzyme 2 (ACE2) Expression by Coronavirus may Facilitate 2019-nCoV Infection. bioRxiv.
18) Devaux, C.A., Rolain, J.M., Colson, P. and Raoult, D., 2020. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19?. International Journal of Antimicrobial Agents, p.105938.
19) Savarino, A., Boelaert, J.R., Cassone, A., Majori, G. and Cauda, R., 2003. Effects of chloroquine on viral infections: an old drug against today's diseases. The Lancet infectious diseases, 3(11), pp.722-727.
20) Golden EB, Cho HY, Hofman FM, Louie SG, Schonthal AH, Chen TC. Quinoline-based antimalarial drugs: a novel class of autophagy inhibitors. Neurosurg Focus. 2015;38(3):E12.
21) Srinivasa, A., Tosounidou, S. and Gordon, C., 2017. Increased incidence of gastrointestinal side effects in patients taking hydroxychloroquine: a brand-related issue?. The Journal of rheumatology, 44(3), pp.398-398.
22) Mavrikakis, M., Papazoglou, S., Sfikakis, P.P., Vaiopoulos, G. and Rougas, K., 1996. Retinal toxicity in long term hydroxychloroquine treatment. Annals of the rheumatic diseases, 55(3), pp.187-189.
23) Easterbrook, M., 1993, October. The ocular safety of hydroxychloroquine. In Seminars in arthritis and rheumatism (Vol. 23, No. 2, pp. 62-67). WB Saunders.
24) Browning, D.J., 2002. Hydroxychloroquine and chloroquine retinopathy: screening for drug toxicity. American journal of ophthalmology, 133(5), pp.649-656.
25) Cubero, G.I., Reguero, J.R. and Ortega, J.R., 1993. Restrictive cardiomyopathy caused by chloroquine. Heart, 69(5), pp.451-452.
26) Costedoat-Chalumeau, N., Hulot, J.S., Amoura, Z., Leroux, G., Lechat, P., Funck-Brentano, C. and Piette, J.C., 2007. Heart conduction disorders related to antimalarials toxicity: an analysis of electrocardiograms in 85 patients treated with hydroxychloroquine for connective tissue diseases. Rheumatology, 46(5), pp.808-810.
27) Rismanbaf, A. and Zarei, S., 2020. Liver and Kidney Injuries in COVID-19 and Their Effects on Drug Therapy; a Letter to Editor. Archives of Academic Emergency Medicine, 8(1), p.17.
28) Wang, Y. and Zhu, L.Q., 2020. Pharmaceutical care recommendations for antiviral treatments in children with coronavirus disease 2019. World Journal of Pediatrics, pp.1-4.

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Chloroquine and hydroxychloroquine: Current evidence for their effectiveness in treating COVID-19 - CEBM

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March 25, 2020 Kerstin Frie and Kome Gbinigie Oxford COVID-19 Evidence Service Team Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences University of Oxford Correspondence to oghenekome.gbinigie@phc.ox.ac.uk Lay Summary by Mandy Payne, Health Watch VERDICT Several in vitro studies report antiviral activity of chloroquine and hydroxychloroquine against SARS-CoV-2.

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Although there is not yet a cure to COVID-19, there have been many attempts to find one. Treatment guidelines have already incorporated the usage of chloroquine (CQ)/hydroxychloroquine (HCQ). However, the exact dosage, duration of the treatment, and side effects of these drugs have not yet been studied. CQ and HCQ have been chosen as ideal candidates for the treatment for many particular reason. CQ was first used as prophylaxis and as treatment for malaria. HCQ, on the other hand, is a more soluble and less toxic metabolite of CQ, which, therefore, causes less side effects and is overall safer. More recently, CQ/HCQ has been used to treat/manage conditisions such as rheumatoid arthritis and has been used in the treatment of HIV (with mixed results). Unfortunately, it is likely to take months for specific treatments of COVID-19 become available, which explains the growing interest in the use of CQ and HCQ as potential treatments.

Sources: https://www.cebm.net/covid-19/chloroquine-and-hydroxychloroquine-current-evidence-for-their-effectiveness-in-treating-covid-19/

https://www.medicalnewstoday.com/articles/who-launch-trial-testing-4-potential-covid-19-treatments

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There has been several researches supporting that an effective cure for the coronavirus has been found in  a common anti-malarial drug. For example, "The coronavirus disease 2019 (COVID-19) virus is spreading rapidly, and scientists are endeavoring to discover drugs for its efficacious treatment in China. Chloroquine phosphate, an old drug for treatment of malaria, is shown to have apparent efficacy and acceptable safety against COVID-19 associated pneumonia in multicenter clinical trials conducted in China. The drug is recommended to be included in the next version of the Guidelines for the Prevention, Diagnosis, and Treatment of Pneumonia Caused by COVID-19 issued by the National Health Commission of the People’s Republic of China for treatment of COVID-19 infection in larger populations in the future."
https://wattsupwiththat.com/2020/03/17/an-effective-treatment-for-coronavirus-covid-19-has-been-found-in-a-common-anti-malarial-drug/

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The coronavirus disease 2019 (COVID-19) virus is spreading rapidly, and scientists are endeavoring to discover drugs for its efficacious treatment in China. Chloroquine phosphate, an old drug for treatment of malaria, is shown to have apparent efficacy and acceptable safety against COVID-19 associated pneumonia in multicenter clinical trials conducted in China. The drug is recommended to be included in the next version of the Guidelines for the Prevention, Diagnosis, and Treatment of Pneumonia Caused by COVID-19 issued by the National Health Commission of the People's Republic of China for treatment of COVID-19 infection in larger populations in the future.

Information related to the author

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Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies

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The coronavirus disease 2019 (COVID-19) virus is spreading rapidly, and scientists are endeavoring to discover drugs for its efficacious treatment in China. Chloroquine phosphate, an old drug for treatment of malaria, is shown to have apparent efficacy and acceptable safety against COVID-19 associated pneumonia in multicenter clinical trials conducted in China.

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Although there are no treatments specific to COVID-19, there are some agents are being used under clinical trial such as, Chloroquine, Hydroxychloroquine, Lopinavir; Ritonavir,  Remdesivir and some immunomodulating agents (alfa-interferon, sarilumab, etc.). There has yet to be a treatment or drug therapy with the intended or desired result for the disease. However, the FDA continues to investigate the use of NSAIDs in patients with COVID-19 symptoms in an attempt to find an effctive therapy for COVID-19. There are concerns for potential worsening of COVID-19 symptoms have been suggested, but confirmatory clinical data is lacking.

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WHO has begun their research to try to put an end to the virus by trial testing 4 potential treatments.  The first trial deals with repurposing an experimental drug that was unsuccessful in treating ebola. They found that the drug relies on a mechanism that appears to be effective against other viruses, specifically the coronavirus. The second treatment includes looking into antimalarial medication. Different countries have been giving this attention because it has potential to be a preventative and curative agent. The third includes antiretroviral drugs. The drug may be able to fight it by targeting a specialized molecule that allows coronaviruses to replicate. However, it was found to be no difference in outcome between patients that received standard care. The fourth is a combination of antiretroviral drugs and interferon-beta.To boost the potential effectiveness of antiretroviral drugs, a trial of combining them with interferon-beta, a compound doctors use as first-line therapy in the treatment of multiple sclerosis is taking place.

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The World Health Organization (WHO) have launched SOLIDARITY, a giant trial, testing the potential of therapies, old and new, to beat the coronavirus that is causing the current pandemic.

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The WHO have launched SOLIDARITY, a trial to test the four most promising treatments for COVID-19.

In a press briefing last Friday, WHO director-general, Dr. Tedros Adhanom Ghebreyesus, announced the launch of SOLIDARITY, a giant multinational trial for testing therapies that researchers have suggested may be effective against COVID-19.

"That's why WHO [have] launched the SOLIDARITY trial, to generate robust, high quality evidence as fast as possible," Dr. Ghebreyesus said.

"I'm glad that many countries have joined the SOLIDARITY trial that will help us to move with speed and volume. The more countries that sign up to the SOLIDARITY trial and other large studies, the faster we will get results on which drugs work, and the more lives we will be able to save."

- Dr. Tedros Adhanom Ghebreyesus

SOLIDARITY includes research looking at four possible therapeutics: remdesivir; chloroquine and hydroxychloroquine; lopinavir plus ritonavir; and lopinavir plus ritonavir and interferon-beta.

Scientists originally developed remdesivir as a drug to treat Ebola. However, clinical trials later indicated that the compound was insufficiently effective against the virus that causes that disease.

The drug relies on a mechanism that appears to be effective against other viruses, specifically coronaviruses, however.

Research, appearing in Science Translational Medicine in 2017, suggested that remdesivir may be able to fight SARS and MERS.

So, more recently, investigators have started experimenting with the drug to fight SARS-CoV-2, the virus that causes COVID-19.

In one case study from earlier this month, doctors reported that a 35-year-old male from the United States, who received remdesivir after contracting the new coronavirus, started to recover soon after he began the drug. There have since been other reports of people recovering from COVID-19 thanks to this drug.
Remdesivir works by inhibiting a specific enzyme, RNA polymerase, which normally allows the virus to replicate. Without that enzyme, the virus becomes less able to maintain its hold on the body.
Commenting on a preliminary in vitro study, suggesting that remdesivir may be effective against SARS-CoV-2, Dr. Andrew Preston, from the University of Bath in the United Kingdom, explains that the drug "mimics one of the building blocks of the viral genome, but is nonfunctional, causing premature termination of virus genome replication."

Doctors have used chloroquine and hydroxychloroquine as antimalarial drugs for decades, but researchers have recently started arguing that they could repurpose these compounds to fight SARS-CoV-2.
A WHO report from March 13 indicates that "chloroquine has received significant attention in [different] countries as a potentially useful prophylactic [preventive] and curative agent, prompting the need to examine emerging evidence to inform a decision on its potential role."
The report weighed the results of different preliminary studies that tested the potential of chloroquine and hydroxychloroquine in the treatment of COVID-19, and it paved the way for larger trials due to verify the effectiveness of these drugs against the new disease.

In his independent comment, Dr. Preston notes that "[t]he anti-viral effects of chloroquine are thought to derive from two distinct functions."

"In one," he explains, "chloroquine blocks the synthesis of parts of the virus receptors on cells, by inhibiting the addition of certain sugar groups to the cell surface that are recognized by the virus."

"In the second mechanism, following attachment of the virus to the cell surface, it is internalized within a membrane-enclosed compartment," which may ultimately inhibit the virus's replication.

The commentator further observes: "The virus escapes from this to reach the internal environment of the cell in a process that is triggered by a reduction in pH (making more acidic) of this compartment. Chloroquine can increase the intracellular pH (make it more alkaline), and this inhibits the escape of the virus into the cell where it replicates."

Ritonavir and lopinavir are two compounds that doctors administer together as antiretroviral therapy - the therapy that treats HIV infections.
Research from The Lancet in January has suggested that this drug combo may be able to fight SARS-CoV-2 by targeting a specialized molecule that allows both HIV and coronaviruses, such as SARS-CoV and MERS-CoV, to replicate.
However, a trial whose results appeared in The New England Journal of Medicine earlier this month, cast a shadow of doubt upon this drug combo's effectiveness.

In this trial, the researchers found that there was virtually no difference in outcome between patients with COVID-19 who received standard care, and those who received ritonavir and lopinavir.

However, the patients who agreed to join the trial had severe symptoms, which may mean that they received the intervention too late for it to be helpful.

To boost the potential effectiveness of ritonavir and lopinavir, one trial is testing a combination of those two drugs and interferon-beta, a compound doctors use as first-line therapy in the treatment of multiple sclerosis.
The trial - called MIRACLE - is currently testing this experimental treatment with the consent of MERS patients.
Yet another upcoming trial - supported by a U.K.-based pharmaceutical company and not part of the WHO effort - aims to use a specific formulation of interferon-beta on its own in the treatment of COVID-19.

"The idea behind the trial is that, by giving more of this molecule to the lung, this could help reduce the severity of infection with COVID-19, especially in those people who have reduced immune responses to the virus," explains Prof. Ian Hall from the University of Nottingham in the U.K. Prof Hall is not associated with the upcoming trial.

The multinational WHO endeavor, as well as unrelated studies and trials taking place around the world, are all part of international efforts to bring SARS-CoV-2 definitively under control.

"We [...] recognize that there is a desperate need for effective therapeutics. There is, currently, no treatment that has been proven to be effective against COVID-19," emphasized Dr. Ghebreyesus in his press briefing.

Yet, he went on to add, "[i]t's great to see the level of energy now being directed to research against COVID-19."
For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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WHO launch trial testing 4 potential treatments for COVID-19

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The World Health Organization (WHO) have launched SOLIDARITY, a giant trial, testing the potential of therapies, old and new, to beat the coronavirus that is causing the current pandemic. In a press briefing last Friday, WHO director-general, Dr. Tedros Adhanom Ghebreyesus, announced the launch of SOLIDARITY, a giant multinational trial for testing therapies that researchers have suggested may be effective against COVID-19.

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During these unprecedented times scientist are working hard to find the cure and how to prevent COVID-19. A new study will test if Hydroxychloroquine can prevent COVID-19. Hydroxychloroquine (HCQ) is an oral prescription drug that has been given to patients who have tested positive for COVID-19 to help treat the many symptoms because of its high in-vitro activity against SARS-CoV-2.   For this study researchers in New York plan to enroll 2000 participants who have been in contact with those who have confirmed or pending diagnoses.

https://www.livescience.com/hydroxychloroquine-prevent-covid-19-study.html

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Chloroquine was first used to help treat malaria. Hydroxychloroquine (HCQ) is a more soluble and less toxic metabolite of chloroquine, which causes less side effects and is, therefore, safer (1-3).More recently, CQ/HCQ has been used to manage conditions such as systemic lupus erythematosus and rheumatoid arthritis.  CQ/HCQ has been used in the treatment of HIV with mixed results (4).  The ability of  CQ/HCQ to inhibit certain coronaviruses, such as SARS-CoV-1, has been explored with promising results (5, 6). Both drugs are affordable and widely available internationally. With decades of experience administering these drugs, their safety profiles are well-established. It is likely to take many months for novel, specific treatments of COVID-19 to become available. As a result, there has been growing interest in the use of CQ and HCQ as potential treatments in the interim.

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March 25, 2020
Kerstin Frie and Kome Gbinigie
Oxford COVID-19 Evidence Service Team
Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences
University of Oxford
Correspondence to oghenekome.gbinigie@phc.ox.ac.uk
Lay Summary by Mandy Payne, Health Watch

VERDICT
Several in vitro studies report antiviral activity of chloroquine and hydroxychloroquine against SARS-CoV-2. In vivo data, although promising, is currently limited to one study with considerable limitations. On the basis of the weak evidence available to date, treatment guidelines have already incorporated the usage of chloroquine/hydroxychloroquine for certain patients with COVID-19.

Further research should address the optimal dose and duration of treatment, and explore side effects and long-term outcomes.

There is a higher risk of side effects in the presence of renal and liver impairment, and there have been isolated reports of COVID-19 disease-causing renal and hepatic injury.

Over twenty in vivo clinical trials have already been registered to test the use of chloroquine and hydroxychloroquine for the treatment of COVID-19.

Contraindications for the use of these drugs must be checked for each individual before treatment. Empirical evidence suggests that hydroxychloroquine has a better safety profile, and it might therefore be preferable to focus research efforts on this less toxic metabolite.

BACKGROUND
Chloroquine (CQ) was first used as prophylaxis and treatment for malaria. Hydroxychloroquine (HCQ) is a more soluble and less toxic metabolite of chloroquine, which causes less side effects and is, therefore, safer (1-3).
More recently, CQ/HCQ has been used to manage conditions such as systemic lupus erythematosus and rheumatoid arthritis. CQ/HCQ has been used in the treatment of HIV with mixed results (4). The ability of CQ/HCQ to inhibit certain coronaviruses, such as SARS-CoV-1, has been explored with promising results (5, 6). Both drugs are affordable and widely available internationally. With decades of experience administering these drugs, their safety profiles are well-established. It is likely to take many months for novel, specific treatments of COVID-19 to become available. As a result, there has been growing interest in the use of CQ and HCQ as potential treatments in the interim.
Results from In Vitro and In Vivo Research In Vitro Studies
There is preliminary in vitro evidence of the ability of CQ and HCQ to inhibit SARS-CoV-2 activity. Liu et al (7) found a similar 50% cytotoxic concentration (CC50 - the concentration which results in 50% cell death) for the two drugs, however, the 50% maximal effective concentration (EC50 - the concentration at which viral RNA increase is inhibited by 50%) was lower for CQ than HCQ, irrespective of the multiplicity of infection (MOI - the ratio of virions to host cells) (7).

By contrast, Yao et al (1) found that HCQ was more potent against SARS-CoV-2 than CQ in vitro (EC50 of 0.72 μM and 5.47 μM, respectively. MOI = 0.01). Wang et al reported in vitro antiviral activity of CQ, with an EC50 of 1.13μM and CC50 >100μM at an MOI of 0.05, and with high selectivity for SARS-CoV-2 rather than host cells (8).
In Vivo Clinical Trials
The empirical evidence for the effectiveness of CQ/HCQ in COVID-19 is currently very limited. First clinical results were reported in a news briefing by the Chinese government in February 2020, revealing that the treatment of over 100 patients with chloroquine phosphate in China had resulted in significant improvements of pneumonia and lung imaging, with reductions in the duration of illness (9). No adverse events were reported. It appears that these findings were a result of combining data from several ongoing trials using a variety of study designs. No empirical data supporting these findings have been published so far.

On the 17th of March 2020, the first clinical trial data were published by Gautret and colleagues in France (2). The researchers conducted an open-label non-randomised controlled trial with 36 patients diagnosed with SARS-CoV-2. Six of these patients were asymptomatic, 22 had upper respiratory tract infection symptoms and eight had lower respiratory tract infection symptoms. Twenty patients were assigned to the treatment group, and received HCQ 200mg three times a day for ten days. The control group received usual care. Six of the patients in the treatment group were also prescribed azithromycin to prevent bacterial superinfection.

The main outcome of the trial was SARS-CoV-2 carriage at Day 6, tested using PCR of SARS-CoV-2 RNA from nasopharyngeal swabs. The results showed that patients in the treatment group were significantly more likely to test negative for the virus on Day 6 than patients in the control group (70% vs 12.5% virologically cured, p<0.001). Moreover, all of the six patients who were treated with a combination of HCQ and azithromycin tested negative on Day 6. The authors argue that this finding speaks to the effectiveness of HCQ and a potential synergistic effect of its combined treatment with azithromycin.

Following the promising results of these first clinical trials, official guidelines recommending the treatment of COVID-19 using CQ/HCQ were published. The National Health Commission of the People's Republic of China published their recommendation mid-February, suggesting to treat patients with 500mg chloroquine phosphate (300mg for CQ) twice per day, for a maximum of 10 days (10). In Italy, the L. Spallanzani National Institute for the Infectious Disease published their recommendations for treatment on the 17th of March, which included the provision of 400mg of HCQ per day or 500mg CQ per day, in combination with another antiviral agent (11).
While the results of these clinical trials sound promising, there are several limitations.
No data from the Chinese research have been published as yet and the results and conclusions can therefore not be peer-reviewed. The trial by Gautret and colleagues also has some limitations. The authors state that an additional six patients were recruited to the trial, but were lost to follow-up for various reasons. The authors excluded these six patients and did not perform intention-to-treat analysis, which may have introduced bias (12). Moreover, the researchers did not recruit the 48 patients necessary to achieve 85% power, as per their own calculations. With a sample size of 36 the trial was therefore underpowered, which may cause exaggeration of effect sizes and false-positive results (13). With viral PCR status at Day 6 as the primary outcome, the trial lacks medium and long-term follow-up data. The authors report that one patient tested negative for the virus on Day 6, but subsequently tested positive on Day 8. Such recurrences of positive test results demonstrate that long-term data is necessary to properly assess whether CQ/HCQ are effective treatments. Finally, the trial did not randomise patients to the control and treatment group, thus potentially introducing allocation bias. Given these considerable limitations of the current evidence, further clinical trials are urgently needed so that we can better understand the effectiveness of CQ and HCQ for the treatment of COVID-19. Fortunately, more than twenty clinical trials are already registered to this purpose (14). The trials employ a variety of study designs (including open-label randomised, open-label non-randomised, and single-blinded randomised), exclusion criteria, and treatment approaches (only CQ/only HCQ/either in combination with another drug) (15). It remains to see whether the results of these trials support further usage of CQ/HCQ for the treatment of COVID-19.
Biological Mechanism of Chloroquine
A number of potential mechanisms of action of CQ/HCQ against SARS-CoV-2 have been postulated. The virus is believed to enter cells by binding to a cell surface enzyme called angiotensin-converting enzyme 2 (ACE2) (16). ACE2 expression is also believed to be upregulated by infection with SARS-CoV-2 (17). Chloroquine may reduce glycosylation of ACE2, thereby preventing COVID-19 from effectively binding to host cells (18). Furthermore, Savarino et al (19) hypothesise that CQ might block the production of pro-inflammatory cytokines (such as interleukin-6), thereby blocking the pathway that subsequently leads to acute respiratory distress syndrome (ARDS). Some viruses enter host cells through endocytosis; the virus is transported within the host cell in a cell-membrane derived vesicle called an endosome, within which the virus can replicate (19). When the endosome fuses with the acidic intracellular lysosome, this leads to rupture of the endosome with the release of the viral contents (19). Chloroquine has been found to accumulate in lysosomes, interfering with this process (20). Chloroquine is also believed to raise the pH level of the endosome, which may interfere with virus entry and/or exit from host cells (6).
Side Effects of Chloroquine
Both CQ and HCQ have been in clinical use for several years, thus their safety profile is well established (18). Gastrointestinal upset has been reported with HCQ intake (21). Retinal toxicity has been described with long-term use of CQ and HCQ (22, 23), and may also be related to over-dosage of these medications (23, 24). Isolated reports of cardiomyopathy (25) and heart rhythm disturbances (26) caused by treatment with CQ have been reported. Chloroquine should be avoided in patients with porphyria (27). Both CQ and HCQ are metabolised in the liver with renal excretion of some metabolites, hence they should be prescribed with care in people with liver or renal failure (27, 28). In a letter to the editor, Risambaf et al (27) raise concerns about reports of COVID-19 causing liver and renal impairment, which may increase the risk of toxicity of CQ/HCQ when it is used to treat COVID-19.

Disclaimer: the article has not been peer-reviewed; it should not replace individual clinical judgement and the sources cited should be checked. The views expressed in this commentary represent the views of the authors and not necessarily those of the host institution, the NHS, the NIHR, or the Department of Health and Social Care. The views are not a substitute for professional medical advice.

Kerstin Frie* is a postdoctoral researcher in the Health Behaviours team of the Nuffield Department of Primary Care Health Sciences, University of Oxford

Kome Gbinigie* is a General Practitioner and doctoral researcher based at the Nuffield Department of Primary Care Health Sciences, University of Oxford

*Co-first authors

SEARCH STRATEGY
We searched Pubmed and Google Scholar on 21st March 2020 using the search terms *chloroquine, coronavirus, SARS-Cov-2, 2019-NCov, and COVID-19. We screened titles and abstracts and included in vitro and in vivo studies of CQ/HCQ for the treatment of SARS-CoV-2. In addition, we included reviews of the existing literature on this topic. We provide a narrative summary of the current literature.
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8) Wang, M., Cao, R., Zhang, L., Yang, X., Liu, J., Xu, M., Shi, Z., Hu, Z., Zhong, W. and Xiao, G., 2020. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell research, 30(3), pp.269-271.
9) Gao, J., Tian, Z. and Yang, X., 2020. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. BioScience Trends.
10) Dong, L., Hu, S. and Gao, J., 2020. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discoveries & Therapeutics, 14(1), pp.58-60.
11) Nicastri, E., Petrosillo, N., Ippolito, G., D'Offizi, G., Marchioni, L., Bartoli, T.A., Lepore, L., Mondi, A., Murachelli, S. and Antinori, A., 2020. National Institute for the Infectious Diseases "L. Spallanzani" IRCCS. Recommendations for COVID-19 Clinical Management. Infectious Disease Reports, 12(1).
12) Ranganathan, P., Pramesh, C.S. and Aggarwal, R., 2016. Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis. Perspectives in clinical research, 7(3), p.144.
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18) Devaux, C.A., Rolain, J.M., Colson, P. and Raoult, D., 2020. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19?. International Journal of Antimicrobial Agents, p.105938.
19) Savarino, A., Boelaert, J.R., Cassone, A., Majori, G. and Cauda, R., 2003. Effects of chloroquine on viral infections: an old drug against today's diseases. The Lancet infectious diseases, 3(11), pp.722-727.
20) Golden EB, Cho HY, Hofman FM, Louie SG, Schonthal AH, Chen TC. Quinoline-based antimalarial drugs: a novel class of autophagy inhibitors. Neurosurg Focus. 2015;38(3):E12.
21) Srinivasa, A., Tosounidou, S. and Gordon, C., 2017. Increased incidence of gastrointestinal side effects in patients taking hydroxychloroquine: a brand-related issue?. The Journal of rheumatology, 44(3), pp.398-398.
22) Mavrikakis, M., Papazoglou, S., Sfikakis, P.P., Vaiopoulos, G. and Rougas, K., 1996. Retinal toxicity in long term hydroxychloroquine treatment. Annals of the rheumatic diseases, 55(3), pp.187-189.
23) Easterbrook, M., 1993, October. The ocular safety of hydroxychloroquine. In Seminars in arthritis and rheumatism (Vol. 23, No. 2, pp. 62-67). WB Saunders.
24) Browning, D.J., 2002. Hydroxychloroquine and chloroquine retinopathy: screening for drug toxicity. American journal of ophthalmology, 133(5), pp.649-656.
25) Cubero, G.I., Reguero, J.R. and Ortega, J.R., 1993. Restrictive cardiomyopathy caused by chloroquine. Heart, 69(5), pp.451-452.
26) Costedoat-Chalumeau, N., Hulot, J.S., Amoura, Z., Leroux, G., Lechat, P., Funck-Brentano, C. and Piette, J.C., 2007. Heart conduction disorders related to antimalarials toxicity: an analysis of electrocardiograms in 85 patients treated with hydroxychloroquine for connective tissue diseases. Rheumatology, 46(5), pp.808-810.
27) Rismanbaf, A. and Zarei, S., 2020. Liver and Kidney Injuries in COVID-19 and Their Effects on Drug Therapy; a Letter to Editor. Archives of Academic Emergency Medicine, 8(1), p.17.
28) Wang, Y. and Zhu, L.Q., 2020. Pharmaceutical care recommendations for antiviral treatments in children with coronavirus disease 2019. World Journal of Pediatrics, pp.1-4.

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Chloroquine and hydroxychloroquine: Current evidence for their effectiveness in treating COVID-19 - CEBM

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March 25, 2020 Kerstin Frie and Kome Gbinigie Oxford COVID-19 Evidence Service Team Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences University of Oxford Correspondence to oghenekome.gbinigie@phc.ox.ac.uk Lay Summary by Mandy Payne, Health Watch VERDICT Several in vitro studies report antiviral activity of chloroquine and hydroxychloroquine against SARS-CoV-2.

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Big Pharmaceutical companies and biotechs are looking to come up with an effective treatment for the Covid-19 coronavirus. However it a new virus that we do not know about. Scientists are still understanding what makes this virus different from others, how it affects different patients who are already ill or perfectly healthy before being caught by the virus. There are no known fully affective treatments as of today, however there are possible treatments and testable therapies. Vaccination is the priority with defeating the spread of the virus, because it cannot be treated like an infection which is exaughsted by using antibiotics.

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Countries affected by the coronavirus

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Coronavirus (2019-nCoV) outbreak in Wuhan

Coronavirus: timeline of events and latest updates

The mysterious coronavirus outbreak in the Chinese city Wuhan, now termed as COVID-19, and its fast spread to many other countries, endangers thousands of lives. The pandemic has catalysed the development of novel coronavirus vaccines across the biotech industry, both by pharmaceutical companies and research organisations such as the National Institutes of Health (NIH), US.

The first COVID-19 vaccine in China is expected to be ready for clinical trials by the end of April, according to Xu Nanping, China's vice-minister of science and technology. Inovio Pharmaceuticals plans to begin clinical trials on a coronavirus vaccine in April this year.

Health officials from WHO have noted that Gilead's remdesivir has demonstrated efficacy in treating the coronavirus infection.

Chloroquine approved for emergency use by US FDA

The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19.

The President of the United States, Donald Trump, had announced on 19 March that chloroquine and hydroxychloroquine/Plaquenil, used to treat malaria and arthritis, were approved by the FDA to be tested as a treatment for COVID-19.

Chloroquine is being tested in various clinical trials conducted by government agencies and academic institutions. Other antivirals drugs are also planned to be fast-tracked for testing for coronavirus.

Favilavir, the first approved coronavirus drug in China

The National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, as a treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province.

Pharmaceutical companies involved in developing coronavirus drugs/vaccines

Here is a list of the major coronavirus drugs that pharmaceutical companies across the world are developing that have the potential to become major coronavirus vaccines or antivirals for treating the contagious coronavirus infection.

Novel coronavirus vaccines

Listed below are the coronavirus vaccines in various stages of development, across the world.

Fusogenix DNA vaccine by Entos Pharmaceuticals

Entos Pharmaceuticals is developing Fusogenix DNA vaccine developed using the Fusogenix drug delivery platform to prevent COVID-19 infections. Fusogenix drug delivery platform is a proteo-lipid vehicle that introduces genetic payload directly into the cells.

Entos is working on developing an optimised payload containing multiple protein epitopes derived from SARS-COV-2 proteins, which will stimulate an immune response in the body to prevent COVID-19 infection.

ChAdOx1 nCoV-19 by University of Oxford

The University of Oxford's ChAdOx1 nCoV-19 is an adenovirus vaccine vector developed by the university's Jenner Institute. The university is testing the vaccine in a clinical trial planned to be conducted in the Thames Valley Region.

Approximately 510 volunteers aged between 18 years and 55 years will be enrolled for the study.

Gimsilumab by Roivant Sciences

Roivant Sciences is advancing the development of Gimsilumab a clinical-stage, human monoclonal antibody. The drug targets granulocyte-macrophage colony stimulating factor (GM-CSF), which is a pro-inflammatory cytokine found in high levels in the serum of COVID-19 patients.

Targeting GM-CSF is expected to reduce lung damage and reduce mortality rate in COVID-19 patients.

AdCOVID by Altimmune

Altimmune has collaborated with the University of Alabama at Birmingham (UAB) to develop a single dose intranasal vaccine for COVID-19 named AdCOVID. The company is currently carrying out immunogenicity studies after, which phase one clinical trial material will be developed.

Altimmune and UAB will work with researchers to conduct preclinical animal studies and phase one clinical trial in the third quarter of 2020.

I-Mab Biopharma is developed TJM2, a neutralising antibody, as a treatment for cytokine storm in patients suffering from a severe case of coronavirus infection. The drug targets the human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is responsible for acute and chronic inflammation.

The company will commence development after receiving approval for the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA).

Coronavirus vaccine by Medicago

Medicago is developing drug candidates against COVID-19 after having produced Virus-Like Particles (VLP) of the coronavirus. The company has formed a collaboration with Laval University's Infectious Disease Research Centre to develop antibodies against SARS-CoV-2.

The company's research activities are being partly funded by the Canadian Institutes for Health Research (CIHR).

AT-100 by Airway Therapeutics

Airway Therapeutics is exploring its novel human recombinant protein named AT-100 (rhSP-D) as a treatment for coronavirus. The company has announced a filing with the Respiratory Diseases Branch of the National Institutes of Health to evaluate the drug.

AT-100 has shown efficacy in preclinical studies in reducing inflammation and infection in the lungs, while also generating an immune response against various respiratory diseases.

TZLS-501 by Tiziana Life Sciences

Tiziana Life Sciences is developing its monoclonal antibody named TZLS-501 for the treatment of COVID-19. TZLS-501 is a human anti-interleukin-6 receptor (IL-6R), which helps in preventing lung damage and elevated levels of IL-6.

The drug works by binding to IL-6R and depleting the amount of IL-6 circulating in the body thereby reducing chronic lung inflammation.

OYA1 by OyaGen

OyaGen's OYA1 has shown strong antiviral efficacy against coronavirus in laboratory essays. It was found to be more effective than chlorpromazine HCl in inhibiting SARS-CoV-2 from replicating in cell culture.

OYA1 was earlier approved as an investigational new drug for treating cancer but abandoned due to lack of efficacy. OyaGen plans to conduct further research on the drug to determine the efficacy in treating coronavirus.

BPI-002 by BeyondSpring

BeyondSpring's BPI-002 is a small molecule agent indicated for treating various infections including COVID-19. It has the ability to activate CD4+ helper T cells and CD8+ cytotoxic T cells and generating an immune response in the body.

If combined with another COVID-19 vaccine, the drug has the ability to generate long-term protection against viral infections. BeyondSpring has filed US patent protection for the drug for treating viral infections.

Altimmune's intranasal coronavirus vaccine

An intranasal Covid-19 vaccine is being developed by US-based clinical-stage biopharmaceutical company, Altimmune.

Design and synthesis of the single-dose vaccine have been completed, while animal testing will follow.

The coronavirus vaccine is being developed based on a vaccine technology platform that is similar to NasoVAX, an influenza vaccine developed by Altimmune.

INO-4800 by Inovio Pharmaceuticals and Beijing Advaccine Biotechnology

Inovio Pharmaceuticals has collaborated with Beijing Advaccine Biotechnology Company to advance the development of the former's vaccine, INO-4800, as a novel coronavirus vaccine. The company has started pre-clinical testing for clinical product manufacturing.

The vaccine development is supported by a $9m grant from the Coalition for Epidemic Preparedness Innovations (CEPI).

Inovio announced an accelerated timeline for the development of the vaccine on 03 March. Preclinical trials are ongoing and the design for human clinical trials have been completed. The company has also prepared 3,000 doses for human clinical trials planned to be conducted across the US, China, and South Korea. Plans for large-scale manufacturing have also been developed.

Human clinical trials in 30 healthy volunteers are expected to commence in April 2020 in the US, followed by China, and South Korea. A phase one clinical trial is planned to be conducted in parallel in China, by Beijing Advaccine. Results from the clinical trials are expected to be available in September 2020.

Inovio aims to produce one million doses of the vaccine by the end of 2020 to perform additional clinical trials or emergency use.

NP-120 (Ifenprodil) by Algernon Pharmaceuticals

Algernon Pharmaceuticals has announced that it is exploring its NP-120 (Ifenprodil) as a potential treatment COVID-19. Ifenprodil is an N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist sold under the brand name Cerocal. It has demonstrated efficacy in improving survivability in mice infected with H5N1.

APN01 by University of British Columbia and APEIRON Biologics

A drug candidate developed by APEIRON Biologics named APN01 is being tested in China in a phase one pilot trial as a treatment for COVID-19. APN01 is based on research conducted by a professor at the University of British Columbia for treating SARS. The research revealed that the ACE2 protein was the main receptor for the SARS virus.

The clinical trial will test the drug's efficacy in reducing the viral load in patients. Data from the trial will be used to determine if additional clinical trials are required to be conducted in larger number of patients.

mRNA-1273 vaccine by Moderna and Vaccine Research Center

Moderna and the Vaccine Research Center, a unit of the National Institute of Allergy and Infectious Diseases (NIAID), have collaborated to develop a vaccine for coronavirus. The vaccine targets the Spike (S) protein of the coronavirus.

The first vials of the vaccine have been manufactured at Moderna's Massachusetts manufacturing plant and shipped to NIAID for phase one human clinical trial. The trial began on 16 March at the Kaiser Permanente Washington Health Research Institute in Seattle, Washington. A total of 45 males and females aged between 18 and 45 have been enrolled for the trial.

The participants will be divided into three cohorts who will be administered 25 microgram (mcg), 100mcg or 250mcg dose 28 days apart.

Avian Coronavirus Infectious Bronchitis Virus (IBV) vaccine by MIGAL Research Institute

The MIGAL Research Institute in Israel announced that an Infectious Bronchitis Virus (IBV) vaccine developed to treat avian coronavirus has been modified to treat COVID-19. The vaccine has demonstrated efficacy in pre-clinical trials conducted by the Volcani Institute.

The IBV vaccine was developed after four years of research and has high genetic similarity to the human coronavirus. The institute has genetically modified the vaccine to treat COVID-19 and will be available in the oral form.

The institute is currently exploring potential partners for producing the vaccine in the next eight to ten weeks and obtaining the necessary safety approvals for in-vivo testing.

TNX-1800 by Tonix Pharmaceuticals

Tonix Pharmaceuticals has partnered with Southern Research, a non-profit research organisation, to develop a vaccine for coronavirus named TNX-1800. The vaccine is a modified horsepox virus developed using Tonix's proprietary horsepox vaccine platform.

TNX-1800 is designed to express a protein derived from the virus that causes the coronavirus infection. Southern Research will be responsible for evaluating the efficacy of the vaccine, under the partnership.

Brilacidin by Innovation Pharmaceuticals

Innovation Pharmaceuticals announced that it is evaluating Brilacidin, a defensin mimetic drug candidate, as a potential treatment for coronavirus. Brilacidin has shown antibacterial, anti-inflammatory and immunomodulatory properties in several clinical trials.

The company is planning to explore research collaborations and seek federal grants to develop the coronavirus drug. It is already investigating the drug for inflammatory bowel disease and oral mucositis in cancer patients.

Innovation has signed two material transfer agreements with a university in the US and 12 biocontainment labs in the US for evaluation of Brilacidin as a treatment for COVID-19. One of the biocontainment labs is scheduled to commence testing of the drug in the third week of March.

Recombinant subunit vaccine by Clover Biopharmaceuticals

Clover Biopharmaceuticals is developing a recombinant subunit vaccine using its patented Trimer-Tag © technology. The company is developing the vaccine based on the trimeric S protein (S-Trimer) of the COVID-19 coronavirus, which is responsible for binding with the host cell and causing a viral infection.

Using Trimer-Tag © technology, Clover successfully produced the subunit vaccine in a mammalian cell-culture based expression system on 10 February. The company also identified antigen-specific antibody in the serum of fully recovered patients who were previously infected by the virus.

A highly purified form of the S-Trimer vaccine is expected to be available in six to eight weeks for performing pre-clinical studies. The company is equipped with in-house cGMP biomanufacturing capabilities to scale-up production if the vaccine is proven to be successful.

Clover is also collaborating with GSK to develop a vaccine using the latter's pandemic adjuvant system.

Vaxart's coronavirus vaccine

Vaxart is developing an oral recombinant vaccine in tablet formulation using its proprietary oral vaccine platform, VAAST.

The company plans to develop vaccines based on the published genome of 2019-nCOV to be tested in pre-clinical models for mucosal and systemic immune responses.

CytoDyn-leronlimab

CytoDyn is examining leronlimab (PRO 140), a CCR5 antagonist, as a potential coronavirus drug.

The drug is already being investigated in phase two clinical trials as a treatment for HIV and has been awarded fast-track approval status by the United States Food and Drug Administration.

Linear DNA Vaccine by Applied DNA Sciences and Takis Biotech

Applied DNA Sciences' subsidiary LineaRx and Takis Biotech formed a joint venture on 07 February to develop a linear DNA vaccine as a treatment for coronavirus. The JV will use Polymerase Chain Reaction (PCR)-based DNA manufacturing technology to develop the vaccine.

The PCR technology offers several advantages including high purity, increased production speed, and absence of antibiotics and bacterial contaminants. Further, the vaccine gene developed through this technology can be effective without being inserted into the patient's genome.

The design for four DNA vaccine candidates is expected to be produced using the PCR technology for carrying out animal testing. The design of one of the vaccine candidates is based on the entire spike gene of the coronavirus, while the remaining are designed based on the antigenic portions of the protein.

BXT-25 by BIOXYTRAN to treat late-stage acute respiratory distress syndrome (ARDS)

BIOXYTRAN announced that it is exploring partners to develop its lead drug candidate, BX-25, as a treatment for Acute Respiratory Distress Syndrome (ARDS) in late-stage patients infected with the coronavirus. The diffusion of oxygen to the blood is comprised in patients suffering from ARDS leading to fluid build-up in the lungs.

BX-25 is designed to be 5,000 times smaller than blood cells and efficiently transport oxygen through the body for a period of nine hours before being processed by the liver. The drug can help in supplying oxygen to the vital organs and enable the patient to recover and survive.

MERS CoV vaccines for coronavirus

Novavax's MERS coronavirus vaccine candidate

Novavax developed a novel Middle East Respiratory Syndrome (MERS) coronavirus vaccine candidate in 2013, post the identification of the first MERS coronavirus ((MERS-CoV) in Saudi Arabia in 2012. It is a crucial target for vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI) and is a priority disease for the World Health Organisation (WHO).

The candidate is designed to primarily bind to the major surface S-protein and developed using the company's recombinant nanoparticle vaccine technology. Tested along with the Novavax's proprietary adjuvant Matrix-M ™, it inhibited infection by inducing immune responses in the laboratory studies.

Novavax has received $4m in funding from CEPI to advance the development of the vaccine. The company has produced several nanoparticle vaccine candidates for testing in animal models and aims to carry out human trials in 2020.

The MERS coronavirus is related to the severe acute respiratory syndrome (SARS) coronavirus, for which the company had previously developed a recombinant nanoparticle vaccine candidate.

Inovio Pharma's INO-4700

The investigational DNA immunotherapy, INO-4700 (GLS-5300) is being developed by Inovio in partnership with GeneOne Life Science. It is delivered as vaccine intramuscularly, using the Cellectra ® delivery device.

The company has received a $5m grant from the Bill and Mellinda Gates foundation to accelerate the development of the Cellectra ® delivery device.

The vaccine was well-tolerated and demonstrated high immune responses against the MERS-CoV in 94% of patients in the early-stage clinical trial in July 2019.

It also generated broad-based T cell responses in 88% of the subjects.

"Research organisations such as the National Institutes of Health (NIH), US are also developing a vaccine for the coronavirus."

Coronavirus drugs

The novel coronavirus drugs in various stages of development globally are listed below.

Remdesivir (GS-5734) by Gilead Sciences

An ebola drug developed by Gilead Sciences that was found to be ineffective is now being tested in two phase III randomised clinical trials in Asian countries.

The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan, the epicentre of the novel coronavirus outbreak. The results from the trials are expected to be available over the next few weeks.

According to a report by The New England Journal of Medicine (NEJM), remdesivir, when administered to a coronavirus patient in the US, appeared to have improved the clinical condition.

The University of Nebraska Medical Center is also carrying out clinical trials to test the safety and efficacy of the drug. The first patient to be administered the drug is an evacuee from the Diamond Princess cruise ship.

Actemra by Roche to treat coronavirus-related complications

China approved the use of Roche's Actemra for the treatment of severe complications related to coronavirus. Drugs like Actemra have the ability to prevent cytokine storms or overreaction of the immune system, which is considered as the main reason behind organ failure leading to death in some coronavirus patients.

Actemra is also being evaluated in a clinical trial in China, which is expected to enroll 188 coronavirus patients. The clinical trial is expected to be conducted until May 10.

Biocryst Pharma's Galidesivir, a potential antiviral for coronavirus treatment

The antiviral drug Galidesivir (BCX4430) has shown broad-spectrum activity against a wide range of pathogens including coronavirus. It is a nucleoside RNA polymerase inhibitor that disrupts the process of viral replication.

The drug has already shown survival benefits in patients against deadly viruses such as Ebola, Zika, Marburg, and Yellow fever.

Galidesivir is currently in advanced development stage under the Animal Rule to combat multiple potential viral threats including coronaviruses, flaviviruses filoviruses, paramyxoviruses, togaviruses, bunyaviruses, and arenaviruses.

Regeneron's REGN3048-3051 and Kevzara

Discovered by Regeneron, the combination of neutralising monoclonal antibodies REGN3048 and REGN3051 is being studied against coronavirus infection in a first-in-human clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The safety and tolerability of the drug will be studied in 48 patients.

Both the antibodies bind to S-protein of MERS coronavirus. The intravenous administration of the drug in the mouse model of MERS resulted in the high-level neutralisation of the MERS coronavirus in circulating blood with reduced viral loads in the lungs.

Regeneron has partnered with Sanofi to evaluated Kevzara, a fully-human monoclonal antibody, in a phase two/three clinical trial in patients with severe COVID-19 infection. Kevzara is approved for the treatment of rheumatoid arthritis and is known to block the interleukin-6 (IL-6) pathway, which causes an overactive inflammatory response in the lungs of COVID-19 patients.

SNG001 by Synairgen Research

Synairgen Research's SNG001, an inhaled drug, is planned to be tested by the University of Southampton to treat asthma, chronic obstructive pulmonary disease and lower respiratory tract illnesses caused by coronavirus.

SNG001 is a formulation of naturally occurring Interferon-β, which is administered through a nebuliser and is delivered directly to the lungs to reduce the severity of the infection caused by coronavirus.

AmnioBoost by Lattice Biologics

Lattice Biologics is exploring the efficacy of its amniotic fluid concentrate, AmnioBoost, in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients. AmnioBoost was developed for chronic adult inflammatory conditions such as osteoarthritis.

The drug has shown efficacy in reducing the inflammatory conditions caused by several diseases including coronavirus. It reduces the production of pro-inflammatory cytokines while boosting the production of anti-inflammatory cytokines.

Other companies developing coronavirus vaccines/drugs

Companies such as Inovio Pharmaceuticals, Moderna, and Novavax have been reported to be developing vaccines. A total of 30 therapies are being tested, including few traditional medicines for coronavirus treatment by Chinese scientists. Chloroquine phosphate has shown efficacy in treating symptoms of the disease, among the 30 therapies. Patients administered with the drug achieved a better drop in fever and shorter recovery time in clinical trials being conducted in hospitals in the Guangdong province and Hunan province.

Enanta Pharmaceuticals

Enanta Pharmaceuticals has announced its plans to develop antiviral drug candidates to treat COVID-19 patients. The company is testing compounds from its existing antiviral compound library for potential efficacy in treating COVID-19. It has also launched a drug discovery programme to develop direct-acting drug candidates to treat COVID-19.

Predictive Oncology

Predictive Oncology has launched an AI Platform for the discovery and development of vaccines against coronavirus. The company has signed an agreement with InventaBioTech to acquire Soluble Therapeutics, which provides it with access to the HSC TM Technology.

Predictive will use the HSC TM Technology along with its predictive modeling platform to deploy an AI discovery platform that can screen the ideal combination of additives and excipients for protein formulations.

Emergent BioSolutions

Emergent BioSolutions is developing two plasma-derived product candidates or hyperimmunes using its hyperimmune platforms for the treatment of coronavirus. The hyperimmune platforms have been used previously for the development of several approved products including vaccines for smallpox, botulism, and anthrax.

The hyperimmunes are polyclonal antibodies derived from plasma, which are capable of generating an immune response and protecting against infection. Product candidate derived from human plasma is named COVID-HIG, while COVID-EIG is derived from equine plasma. Both will be explored for the treatment of patients with a severe case of infection.

Integral Molecular

Integral Molecular has launched a vaccine programme using its two technology platforms including Shotgun Mutagenesis Epitope Mapping and the Membrane Proteome Array. The technologies will help in understanding the human immune response to the coronavirus and isolate the cellular receptors that enable the virus to spread quickly.

The Shotgun technology helps in identifying more than 1,000 binding sites for antibodies, while the Membrane Proteome Array technology is capable of identifying the receptors through which viruses infect cells.

CEL-SCI

CEL-SCI is developing immunotherapy against COVID-19 using its proprietary LEAPS peptide technology, which utilises conserved areas of the coronavirus proteins to generate T-cell responses and reduce viral load. The technology can also be used to develop immunotherapeutic peptides with both antiviral and anti-inflammatory properties.

The peptides developed using this technology can help in reducing tissue damage from inflammation caused due to lung infection, which is a major cause of mortality in elderly patients.

AJ Vaccines

AJ Vaccines has launched the development of a vaccine against COVID-19. The company will use the latest technology to develop antigens that can mimic the native structures of the virus. The vaccine will be capable of inducing a strong immune response in the body thereby protecting against the infection.

Takeda Pharmaceutical Company

Takeda Pharmaceutical Company has announced plans to develop a plasma-derived therapy against coronavirus. The anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) therapy will be designed to treat high-risk patients. The H-IG therapy includes concentrated pathogen-specific antibodies derived from plasma of recovered patients. These antibodies have the potential to generate an immune response when injected into a new patient.

Heat Biologics

Heat Biologics has announced plans to develop a vaccine to treat or prevent coronavirus infection using its proprietary gp96 vaccine platform. The technology is capable of reprogramming live cells to produce antigens that can bind to the gp96 protein and generate an immune response against those antigens.

Pfizer

Pfizer announced that it has identified certain under development antiviral compounds that may be effective in treating coronavirus. The company is planning to partner with a third party to screen and identify potential compounds by the end of March and begin testing in April.

Mateon Therapeutics

Mateon Therapeutics has launched an antiviral response programme to develop coronavirus treatments using its therapeutic and artificial intelligence (AI) platforms. It has also established a division, which will adopt a multi-modal approach to developing COVID-19 treatments as well as other future zootonic outbreaks.

Hong Kong University of Science and Technology

The Hong Kong University of Science and Technology has identified several vaccine targets, which can be developed as a treatment for coronavirus. Researchers at the university have identified B-cell and T-cell epitopes, which are capable of generating an immune response against the SARS virus and a similar response against the coronavirus.

Some of the epitopes identified may be capable of generating an immune response specifically against COVID-19.

Vaccine by Generex

Generex has announced that it is developing a COVID-19 vaccine following a contract from a Chinese consortium comprising of China Technology Exchange, Beijing Zhonghua Investment Fund Management, Biology Institute of Shandong Academy of Sciences and Sinotek-Advocates International Industry Development.

The company will utilise its Ii-Key immune system activation technology to produce a COVID-19 peptide for human clinical trials.

Generex will receive an upfront payment of $1m to commence the groundwork for the vaccine development and $5m licensing fee for its Ii-Key technology. It is also eligible to receive a 20% royalty on every dose of vaccine produced under the contract.

Coronavirus drugs by Columbia University

Researchers at Columbia University have been awarded a $2.1m grant by the Jack Ma Foundation to develop a coronavirus cure. Four different teams at the university will adopt various approaches towards the development of a vaccine against coronavirus.

Vaccine by Tulane University

Tulane University has launched a research programme to identify a potential coronavirus medicine in the form of a vaccine. The university will utilise a grant from the Brown Foundation to carry out the research activities.

Coronavirus vaccine by ImmunoPrecise Antibodies

ImmunoPrecise Antibodies has launched a vaccine and therapeutic antibody programme to develop a vaccine as well as antibodies against COVID-19. The company will use its B Cell Select™ and DeepDisplay™ discovery platforms to therapeutic compounds against the coronavirus.

The company has updated its research efforts and noted that it will be using the PolyTope mAb Therapy TM and EVQLV's artificial intelligence platforms develop a COVID-19 therapy.

Serum Institute of India

Serum Institute of India (SII) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a cure for coronavirus using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022.

Southwest Research Institute

Southwest Research Institute is using its virtual screening called Rhodium to identify potential drug candidates for treating coronavirus from more than two million drug compounds. The most promising compounds will be identified for further development.

Zydus Cadila

Zydus Cadila announced the launch of an accelerated research programme to develop a vaccine for COVID-19 using two novel approaches. The first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach. The rMV-based vaccine works by inducing specific neutralising antibodies, which will provide protection from the coronavirus infection.

NanoViricides

NanoViricides, a clinical-stage company, is working on developing a treatment for nCoV-2019 using its nanoviricide ® technology. The company's technology is used to develop ligands that can bind to the virus in the same way as a cognate receptor and attack various points of the virus.

Vir Biotechnology

Vir Biotechnology, a clinical-stage immunology company, announced on 12 February that it has identified two monoclonal antibodies that can bind to the virus that causes COVID-19. The antibodies target the spike (S) protein of the virus by entering through the cellular receptor ACE2.

The company has formed a partnership with WuXi Biologics on 25 February to commercialise the antibodies identified to treat coronavirus. If approved, Wuxi will have the rights to market the therapies in China, while Vir will retain the marketing rights in other countries.

Vir has also partnered with Alnylam Pharmaceuticals to identify siRNA candidates targeting SARS-CoV-2. It has formed another partnership with Biogen for cell line and process development and manufacturing of the antibodies.

HIV drugs for coronavirus treatment

Abbvie's HIV protease inhibitor, lopinavir is being studied along with ritonavir for the treatment of MERS and SARS coronaviruses. The repurposed drug is already approved for the treatment of HIV infection under the trade name Kaletra ®.

The combination is listed in the WHO list of essential medicines. Lopinavir is believed to act on the intracellular processes of coronavirus replication and demonstrated reduced mortality in the non-human primates (NHP) model of the MERS.

Lopinavir/ritonavir in combination with ribavirin showed reduced fatality rate and milder disease course during an open clinical trial in patients in the 2003 SARS outbreak.

Cipla is also reportedly planning to repurpose its HIV drug LOPIMUNE, which is a combination of protease inhibitors Lopinavir and Ritonavir, for the treatment of coronavirus.

A licensed generic of Kaletra ®, LOPIMUNE is currently available in packs of 60 tablets each, containing 200mg of Lopinavir and 50mg of Ritonavir.

Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, donated its PREZCOBIX ® HIV medication (darunavir/cobicistat) for use in research activities aimed at finding a treatment for COVID-19.

Darunavir is a protease inhibitor marketed by Janssen. Anecdotal reports suggest darunavir as potentially having antiviral activity against COVID-19. It is, however, currently approved only for use with a boosting agent, and in combination with other antiretrovirals, for the treatment of HIV-1.

Janssen has no in vitro or clinical data to support the use of darunavir as a treatment for COVID-19. The drug is in the process of being evaluated in vitro for any potential activity against the coronavirus.

Further, Janssen has partnered with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the development of a COVID-19 treatment.

The Coronavirus outbreak

The contagious coronavirus outbreak at the end of 2019, which the WHO named as COVID-19 (formerly 2019-nCoV), led to a medical emergency across the world.

Similar infections are caused by human alpha and beta coronaviruses such as 229E, NL63, OC43 and HKU1.

What are the symptoms?

Coronavirus symptoms include those associated with common cold, such as running nose, headache, cough, fever, and sore throat.

Coronavirus transmission

"Coronavirus transmission can happen human-to-human as well as from infected animals such as dogs and cats."

COVID-19 is a betacoronavirus that has origin in bats, according to the Centers for Disease Control and Prevention (CDC).

Believed to have transmitted from animals and reptiles such as snakes, coronaviruses cause respiratory issues such as upper respiratory tract illnesses and lower respiratory illnesses such as pneumonia and bronchitis.

Coronavirus transmission can happen human-to-human as well as from infected animals such as dogs and cats.

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Coronavirus outbreak: Top coronavirus drugs and vaccines in development

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Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.

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During this rush to eradicate the  newest strand of corona, known as COVID-19, Big Pharma and BioTech companies have tested various treatment options to find a possible breakthrough. Currently researchers are looking into cell-based therapy, anti-bodies, anti-virals and RNA based therapy to say a few. Many believe re-purposing drugs is the key.One drug in particular that might wind up being effective in treating symptoms is remdesivir, a drug made by Gilead Sciences that was originally used for Ebola and other highly contagious diseases. The hope is that remdesivir or another preexisting drug canhelp alleviate the worst symptoms from the coronavirus, buying more time for companies developing vaccines to come up with a longer term solution to stop the spread of the disease.
SOURCES:
https://milkeninstitute.org/covid-19-tracker
https://www.cnn.com/2020/03/30/investing/coronavirus-covid-19-vaccines-drugs/index.html

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There is a desperate need to find new medicines to treat Covid-19, the disease caused by the novel coronavirus that has shut down much of the world. The drug companies and the medical researchers are making efforts to deliver new medicines. Doctors on the front lines have been trying older medicine, such as the malaria drugs hydroxychloroquine, in the hopes that it'll be effective. But the relentless pace of the virus’ spread and a sense of desperation can only do so much to speed up the development of new medicines. Normally, the process to develop new medicines can take a decade or more. And many experimental medicines fail. The early hope is on hydroxychloroquine and chloroquine and many hospitals include them in their treatment guideline. Some doctors are combining hydroxychloroquine with azimuthromycin, an antibiotic.

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here is a desperate need for new medicines to treat Covid-19, the disease caused by the novel coronavirus that has shut down much of the world. A vaccine to prevent infection entirely would be even better.

Drug companies and medical researchers are making heroic efforts to deliver new medicines. Several dozen are now in development, and you can see highlights of those efforts . Studies so far are mostly small and lack real control groups, making it hard for researchers to be sure of their conclusions.

Doctors on the front lines have been trying older medicines, such as the malaria drugs hydroxychloroquine and chloroquine , in the hopes that they will prove effective. Large studies of such medicines are already in process.

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But the relentless pace of the virus' spread and a sense of desperation can only do so much to speed up the development of new medicines. Normally, the process to develop new medicines can take a decade or more. And many experimental medicines fail. When it comes to infectious disease treatments, data from the Biotechnology Innovation Organization put the success rate of new medicines just starting clinical testing at 1 in 5.

Is there hope that something will be available soon to help us fight this virus, known as SARS-CoV-2? Here's a look at what's on tap and how soon it could be ready. For almost any treatment or preventative, supply could be an issue if large numbers of people need it. Lastly, please note: Some of these timelines could shift, and some of these treatments and vaccines are likely to fail. That is the unfortunate reality of how medicine works.

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Existing antiviral medicines Timeline: Available now, but efficacy testing could take a month or more.

An existing, easy-to-produce medicine that proved effective at treating or preventing SARS-CoV-2 infection would provide the fastest relief for patients and doctors. The early hope is on hydroxychloroquine and chloroquine, and many hospitals, including the University of California, San Francisco, and the University of Washington, include them in their treatment guidelines. Some doctors are combining hydroxychloroquine with azithromycin, an antibiotic. Much of the published evidence comes from a very small French study and reports from China. Larger, more rigorous clinical trials are starting, but they will take time. Favipiravir, a flu drug shown in Japan, appeared beneficial in another small study. These medicines, especially the malaria drugs, which are being mass-produced, will be used by doctors on the front lines, but we will have to wait for evidence of whether they are benefitting patients and how much.

, an antiviral medicine that failed as an Ebola treatment, was initially developed to work against a different coronavirus. There's some evidence that it benefits Covid-19 patients. Its maker, Gilead, has been working with researchers and governments around the world to get clinical trials up and running. The company has said to expect results in April. Six large studies are in progress, with the first, in severely ill patients in China, d Remdesivir
Timeline: First data could come in April
Remdesivir ue to finish as early as April 3, according to a government website. A study in patients with milder disease will also finish in April, with two more due in May. In the meantime, Gilead has made the drug available to hundreds of patients on a compassionate use basis. However, it recently said that, due to overwhelming demand, it would suspend access to the drug for all but pregnant women and children as it works to create a more systematic way of giving it out without interfering with clinical trials. This new system should be in place soon. Remdesivir must be given intravenously.

Convalescent plasma
Timeline: May see some use immediately, but research could take months

It's an old idea that has proven effective in other epidemics: give patients who are sick from those who have recovered. It can work because the plasma contains antibodies against the virus, weaponizing the immune system of the sick patient. blood plasma

One recent study reported that of 10 patients given convalescent plasma, seven saw their viral loads become undetectable; it noted other improvements in their condition.

Takeda is developing a more refined version of this approach that uses more concentrated antibodies taken from blood. Julie Kim, the president of the company's blood products division, said last Wednesday on a conference call with reporters organized by PhRMA, the trade group, that the product may be available in nine to 18 months.

Arthritis drugs
Timeline: Data could be available by summer; drugs available now

Drugs against autoimmune diseases like rheumatoid arthritis work by tamping down the immune system. This could, ironically, be useful against in Covid-19, because the SARS-CoV-2 virus can make the body overreact, causing what's called a "cytokine storm," damaging the body.

Actemra, one such drug made by Roche, is approved for treating the cytokine storm when it is caused by cancer treatments. An unpublished 21-patient study in China showed Actemra reduced fevers and need for supplemental oxygen. Two other firms, Regeneron and Sanofi, launched a study of their similar drug, Kevzara, in Covid-19 patients; the pair has said results on fevers and oxygen use could be available as early as April. Roche has begun its own study of Actemra in the U.S. Both Actemra and Kevzara are artificial antibodies that target a protein involved in the immune system called IL-6, and are given by injection.

Artificial antibodies against the virus Timeline: Potentially early fall

Many of the pharmaceutical industry's best-sellers are what are called monoclonal antibodies, which are antibodies developed in mice and then made into drugs that can be injected into patients. A manufactured antibody, or a mix of manufactured antibodies, might have a more consistent impact than using blood plasma, and it can be off-the-shelf. Regeneron, the Tarrytown, N.Y., biotech, had success developing a mixture of antibodies against Ebola; it is now selecting two to use against SARS-CoV-2 , with the expectation that trials could start by early summer. If all goes well, it could be available by early fall for some uses, like treating extremely sick patients. Eli Lilly, working with a Vancouver startup called AbCellera, has said it hopes to start trials of a similar approach within four months. Vir Biotechnology and Biogen are following a similar path. Antibodies might also be used to prevent infection, but that could take longer to test in studies.

If existing antivirals cannot control SARS-CoV-2, brand new medicines may be needed. But this process is at square one, and even moving at full-speed could eat up months. Efforts are underway to search chemical libraries for medicines that could prove effective by the Bill and Melinda Gates Foundation and others. If they can find medicines that have gone through some previous testing, as remdesivir has, that could hasten the process.

Timeline: Late 2021, possibly many years

There is one approach that could deliver a vaccine faster than others: It uses messenger RNA to make cells produce proteins that could lead to immunity. This approach has never been used in a widely available vaccine. The biotech Moderna is in the lead here , but others, such as BioNTech, working with Pfizer, are working on a similar approach.

It could take 18 months to be sure that approach works and is broadly safe. Even with increased manufacturing capacity, supply could be a problem. Other approaches are being developed in tandem, including one from Sanofi, now used for flu vaccines, that manufactures vaccines in insect cells. However, Moderna said in a filing with the SEC Monday that its vaccine might be available for some groups, including health care workers, as early as fall 2020.

"If you look across the many programs that have been launched, if you look at history, not all of those programs will be successful," said Rajeev Venkayya, president of Takeda's global vaccines unit, during a press conference last week. "And I think that is something that I don't think we've effectively communicated to the public. Just because we start a vaccine program doesn't mean that we will definitely get a vaccine on the other end."

The good news about having so many efforts in progress, he said, is it increases the chances that one will succeed.

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When might experimental drugs to treat Covid-19 be ready? A forecast

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here is a desperate need for new medicines to treat Covid-19, the disease caused by the novel coronavirus that has shut down much of the world. A vaccine to prevent infection entirely would be even better. Drug companies and medical researchers are making heroic efforts to deliver new medicines.

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For the recent COVID-19 pandemic, there are many treatments and therapies being tested. Instead of coming up with totally new medications,  WHO scientists are testing already existing treatments to see if they are the definite cure. For example, they are using an experimental antiviral called remdesivir. This therapy is used for Ebola, and it shuts down viral replication by inhibiting key viral enzymes. Next is chloroquine (or its chemical cousin hydroxychloroquine). It is being used for Malaria, and it decreases acidity in endosomes. Also, a combination of the HIV drugs lopinavir and ritonavir. This uses an enzyme that creates a long protein chain when a new virus develops.

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With cases of the new coronavirus disease 2019 (COVID-19) climbing steeply everywhere from Madrid to Manhattan , overwhelming one hospital after another and pushing the global death toll past 17,000, the sprint to find treatments has dramatically accelerated. Drugs that stop the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), could save the lives of severely ill patients, protect health care workers and others at high risk of infection, and reduce the time patients spend in hospital beds.

The World Health Organization (WHO) last week announced a major study to compare treatment strategies in a streamlined clinical trial design that doctors around the world can join. Other trials are also underway; all told, at least 12 potential COVID-19 treatments are being tested, including drugs already in use for HIV and malaria, experimental compounds that work against an array of viruses in animal experiments, and antibody-rich plasma from people who have recovered from COVID-19. More than one strategy may prove its worth, and effective treatments may work at different stages of infection, says Thomas Gallagher, a coronavirus researcher at Loyola University Chicago's Health Sciences Campus. "The big challenge may be at the clinical end determining when to use the drugs."

Researchers want to avoid repeating the mistakes of the 2014-16 West African Ebola epidemic, in which willy-nilly experiments proliferated but randomized clinical trials were set up so late that many ended up not recruiting enough patients. "The lesson is you start trials now," says Arthur Caplan, a bioethicist at New York University's Langone Medical Center. "Make it a part of what you're doing so that you can move rapidly to have the most efficacious interventions come to the front."

To that end, WHO on 20 March announced the launch of SOLIDARITY, an unprecedented, coordinated push to collect robust scientific data rapidly during a pandemic. The study, which could include many thousands of patients in dozens of countries, has emphasized simplicity so that even hospitals overwhelmed by an onslaught of COVID-19 patients can participate. WHO's website will randomize patients to local standard care or one of the four drug regimens, using only ones available at the patient's hospital. Physicians will simply record the day the patient left the hospital or died, the duration of the hospital stay, and whether the patient required oxygen or ventilation. "That's all," says Ana Maria Henao Restrepo, a medical officer at WHO's Emergencies Programme.

The design is not blinded: Patients will know they received a drug candidate, and that could cause a placebo effect, Henao Restrepo concedes. But it is in the interest of speed, she says. "We are doing this in record time." The agency hopes to start to enroll patients this week.

Rather than taking years to develop and test compounds from scratch, WHO and others want to repurpose drugs that are already approved for other diseases and have acceptable safety profiles. They're also looking at experimental drugs that have performed well in animal studies against the other two deadly coronaviruses, which cause SARS and Middle East respiratory syndrome (MERS). And they are focusing on compounds plentiful enough to treat a substantial number of patients.

For its study, WHO chose an experimental antiviral called remdesivir; the malaria medication chloroquine (or its chemical cousin hydroxychloroquine); a combination of the HIV drugs lopinavir and ritonavir; and that combination plus interferon-beta, an immune system messenger that can help cripple viruses. The treatments would stop the virus by different mechanisms, but each has drawbacks.

Remdesivir, developed by Gilead Sciences to combat Ebola and related viruses, shuts down viral replication by inhibiting a key viral enzyme, the RNA polymerase. It didn't help patients with Ebola in a test during the 2019 outbreak in the Democratic Republic of the Congo. But in 2017, researchers showed in test tube and animal studies that the drug can inhibit the SARS and MERS viruses.

The drug, which is given intravenously, has been used in hundreds of COVID-19 patients in the United States and Europe under what's known as compassionate use, which required Gilead to review patient records; some doctors have reported anecdotal evidence of benefit, but no hard data. Gilead says it is now starting to supply remdesivir under a simpler "expanded use" designation. Five other clinical trials underway in China and the United States are testing it and may have preliminary results soon. Of the drugs in the SOLIDARITY trial, "remdesivir has the best potential," says Shibo Jiang of Fudan University, who works on coronavirus therapeutics.

Like most drugs for acute infections, remdesivir may be much more potent if given early, says Stanley Perlman, a coronavirus researcher at the University of Iowa-and that could be a challenge. "What you really want to do is give a drug like that to people who walk in with mild symptoms," he says. "And you can't do that because it's an [intravenous] drug, it's expensive, and 85 out of 100 people don't need it" because they won't develop severe disease.

Chloroquine and hydroxychloroquine have received intense attention because of positive results from small studies and an endorsement from President Donald Trump, who said, "I feel good about it." The drugs decrease acidity in endosomes, compartments that cells use to ingest outside material and that some viruses co-opt during infection. But SARS-CoV- 2's main entryway is different: It uses its so-called spike protein to attach to a receptor on the surface of human cells. Studies in cell culture have suggested chloroquine can cripple the virus, but the doses needed are usually high and could cause severe toxicity. "Researchers have tried this drug on virus after virus, and it never works out in humans," says Susanne Herold, an expert on pulmonary infections at the University of Giessen.

Results from COVID-19 patients are murky. Chinese researchers who treated more than 100 patients touted chloroquine's benefits in a letter in BioScience, but they did not publish data. And WHO says "no data has been shared" from more than 20 other COVID-19 studies in China using chloroquine or hydroxychloroquine. French microbiologist Didier Raoult and colleagues published a study of hydroxychloroquine in 20 COVID-19 patients that concluded the drug had reduced viral load in nasal swabs. (It seemed to work even better with the antibiotic azithromycin.) But the trial, reported in the International Journal of Antimicrobial Agents, was not randomized, and it didn't report clinical outcomes such as deaths.

Hydroxychloroquine might actually do more harm than good. It has many side effects and can, in rare cases, harm the heart-and people with heart conditions are at higher risk of severe COVID-19, says David Smith, an infectious disease physician at the University of California, San Diego. "This is a warning signal, but we still need to do the trial," he says. There have also been reports of chloroquine poisoning in people who self-medicated.

Many coronavirus researchers are similarly skeptical of the lopinavir-ritonavir combination. Abbott Laboratories developed the drugs to inhibit the protease of HIV, an enzyme that cleaves a long protein chain during assembly of new viruses. The combination has worked in marmosets infected with the MERS virus, and has also been tested in patients with SARS and MERS, though those results are ambiguous. But the first trial with COVID-19 was not encouraging. When doctors in Wuhan, China, gave 199 patients standard care with or without lopinavir-ritonavir, the outcomes did not differ significantly, they reported in The New England Journal of Medicine on 15 March. The authors say the patients were very ill and treatment may have started too late.

The fourth arm of SOLIDARITY combines these two antivirals with interferon-beta, a molecule involved in regulating inflammation that has lessened disease severity in marmosets infected with MERS. But interferon-beta might be risky for patients with severe COVID-19, Herold says. "If it is given late in the disease it could easily lead to worse tissue damage, instead of helping patients," she cautions.

SOLIDARITY is designed to provide a quick, useful verdict, based on the outcomes that are the most relevant for public health, says virologist Christian Drosten of the Charité University Hospital in Berlin. More detailed data could come from an add-on trial in Europe, announced on 23 March by the French biomedical research agency INSERM. To include 3200 patients, it will test the same drugs, including hydroxychloroquine but not chloroquine, and collect additional data such as blood gas levels or lung imaging.

Other approved and experimental treatments are in testing against coronavirus or likely soon to be. They include drugs that can reduce inflammation, such as corticosteroids and baricitinib, a treatment for rheumatoid arthritis. Some researchers have high hopes for camostat mesylate, a drug licensed in Japan for pancreatitis, which inhibits a human protein involved with infection. Other antivirals will also get a chance, including the influenza drug favipiravir and additional HIV antiretrovirals. Researchers also plan to try to boost immunity with "convalescent" plasma from recovered COVID-19 patients or monoclonal antibodies directed at SARS-CoV-2.

Perlman says the smartest way to test the drugs is in people in early stages of disease who doctors think are most likely to get much worse. How would you determine that? "That is the key question," he says. Researchers might find a biomarker in blood that helps them predict disease course.

Crucially, doctors and researchers around the world are tackling the problem with urgency, Henao Restrepo says. "This is a crisis like no other and we will have to work together," she says. "That is the only way perhaps we are going to find a solution."

Correction (30 March 2020): Ana Maria Henao Restrepo's role at WHO has been updated.

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Race to find COVID-19 treatments accelerates

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With cases of the new coronavirus disease 2019 (COVID-19) climbing steeply everywhere from Madrid to Manhattan , overwhelming one hospital after another and pushing the global death toll past 17,000, the sprint to find treatments has dramatically accelerated.

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In the past, two different strands of the coronavirus disease have caused widespread epidemics: SARS and MERS. The new, highly contagious strand is COVID-19, meaning coronavirus disease 2019. Different drugs have been tested as possible treatments for the COVID-19. A Japanese drug used to treat the flu has shown effectiveness in some areas. The drugs Chloroquine and hydroxychloroquine could prove to be effective against COVID-19. Both have been used to fight other viruses. The drugs have been tested in different countries such as France and have shown some promise. Another possible cure may come from an unexpected source: an unsuccessful ebola drug. The drug, remdesivir, has been able to inhibit the growth of SARS and MERS. As of today, it has been the drug that has shown the most promise, but it has only been tested on patients who show the most severe symptoms.

Sources: https://www.livescience.com/coronavirus-covid-19-treatments.html

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Hydroxychloroquine is an oral prescription drug that is administered to patients who have been detected to have COVID-19. This drug has a high in-vitro activity against SARS-CoV-2 and is given to hospitalized patients to help reduce the severity of the symptoms. It is usually used to treat malaria, lupus, arthritis, and other autoimmune diseases. A small study indicates that hydroxycholoroquine can reduce the detections of the virus in the upper respiratory tract, but did not evaluate the clinical benefit. There is not much information regarding the clinical trials of this drug, but all we know is that many will be enrolled soon.

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Centers for Disease Control and Prevention

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There are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present clinical management includes infection prevention and control measures and supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe. The purpose of this document is to provide information on two of the approved drugs (chloroquine and hydroxychloroquine) and one of the investigational agents (remdesivir) currently in use in the United States.

Remdesivir

Remdesivir is an investigational intravenous drug with broad antiviral activity that inhibits viral replication through premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related betacoronaviruses .

There are currently four options for obtaining remdesivir for treatment of hospitalized patients with COVID-19 and pneumonia in the United States:

A National Institutes of Health (NIH)-sponsored adaptive double-blinded, placebo-controlled trial of remdesivir versus placebo in COVID-19 patients with pneumonia and hypoxia is enrolling non-pregnant persons aged 18 years and older with oxygen saturation of ≤94% on room air or requiring supplemental oxygen or mechanical ventilation (https://clinicaltrials.gov/ct2/show/NCT04280705external icon ). Exclusion criteria include alanine aminotransaminase or aspartate aminotransaminase levels >5 times the upper limit of normal, stage 4 severe chronic kidney disease or a requirement for dialysis (i.e., estimated glomerular filtration rate (eGFR) <30);

Two phase 3 randomized open-label trials of remdesivir (5-days versus 10-days versus standard of care) are open to enrollment in persons aged 18 years and older with COVID-19, radiographic evidence of pneumonia and oxygen saturation of ≤94% on room air (severe disease https://clinicaltrials.gov/ct2/show/NCT04292899external icon ) or >94% on room air (moderate disease https://clinicaltrials.gov/ct2/show/NCT04292730external icon ). Exclusion criteria include alanine aminotransaminase or aspartate aminotransaminase levels >5 times the upper limit of normal, participation in another clinical trial of an experimental treatment for COVID-19, requirement for mechanical ventilation, or creatinine clearance <50 mL/min; and

Finally, in areas without clinical trials, COVID-19 patients in the United States and other countries have been treated with remdesivir on an uncontrolled compassionate use basis. The manufacturer is currently transitioning the provision of emergency access to remdesivir from individual compassionate use requests to an expanded access program. The expanded access program for the United States is under rapid development. Further information is available at: https://rdvcu.gilead.com/external icon

Hydroxychloroquine and Chloroquine

Hydroxychloroquine and chloroquine are oral prescription drugs that have been used for treatment of malaria and certain inflammatory conditions. Chloroquine has been used for malaria treatment and chemoprophylaxis, and hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda. Both drugs have in-vitro activity against SARS-CoV, SARS-CoV-2, and other coronaviruses, with hydroxychloroquine having relatively higher potency against SARS-CoV-2 . A study in China reported that chloroquine treatment of COVID-19 patients had clinical and virologic benefit versus a comparison group, and chloroquine was added as a recommended antiviral for treatment of COVID-19 in China . Based upon limited in-vitro and anecdotal data, chloroquine or hydroxychloroquine are currently recommended for treatment of hospitalized COVID-19 patients in several countries. Both chloroquine and hydroxychloroquine have known safety profiles with the main concerns being cardiotoxicity (prolonged QT syndrome) with prolonged use in patients with hepatic or renal dysfunction and immunosuppression but have been reportedly well-tolerated in COVID-19 patients.

Due to higher in-vitro activity against SARS-CoV-2 and its wider availability in the United States compared with chloroquine, hydroxychloroquine has been administered to hospitalized COVID-19 patients on an uncontrolled basis in multiple countries, including in the United States. One small study reported that hydroxychloroquine alone or in combination with azithromycin reduced detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit . Hydroxychloroquine and azithromycin are associated with QT prolongation and caution is advised when considering these drugs in patients with chronic medical conditions (e.g. renal failure, hepatic disease) or who are receiving medications that might interact to cause arrythmias.

Hydroxychloroquine is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. In the United States, several clinical trials of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection are planned or will be enrolling soon. More information on trials can be found at: https://clinicaltrials.gov/external icon .

There are no currently available data from Randomized Clinical Trials (RCTs) to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection. Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some U.S. clinicians have reported anecdotally different hydroxychloroquine dosing such as: 400mg BID on day one, then daily for 5 days; 400 mg BID on day one, then 200mg BID for 4 days; 600 mg BID on day one, then 400mg daily on days 2-5.

Other Drugs

Lopinavir-ritonavir did not show promise for treatment of hospitalized COVID-19 patients with pneumonia in a recent clinical trial in China . This trial was underpowered, and lopinavir-ritonavir is under investigation in a World Health Organization study.

Several other drugs are under investigation in clinical trials or are being considered for clinical trials of prophylaxis or treatment of COVID-19 in the United States and worldwide. Information on registered clinical trials for COVID-19 in the United States is available at: https://clinicaltrials.gov/external icon .

References

1. Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271.

2. Sheahan TP, Sims AC, Leist SR, Schäfer A, Won J, Brown AJ, Montgomery SA, Hogg A, Babusis D, Clarke MO, Spahn JE, Bauer L, Sellers S, Porter D, Feng JY, Cihlar T, Jordan R, Denison MR, Baric RS. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun. 2020 Jan 10;11(1):222.

3. Sheahan TP, Sims AC, Graham RL, Menachery VD, Gralinski LE, Case JB, Leist SR, Pyrc K, Feng JY, Trantcheva I, Bannister R, Park Y, Babusis D, Clarke MO, Mackman RL, Spahn JE, Palmiotti CA, Siegel D, Ray AS, Cihlar T, Jordan R, Denison MR, Baric RS. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med. 2017 Jun 28;9(396).

4. Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Mar 4:105932. doi: 10.1016/j.ijantimicag.2020.105932. [Epub ahead of print]

5. Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237. [Epub ahead of print]

6. Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73

7. Gautret P, Lagier J, Parola P, Hoang V, Meddeb L, Mailhe M, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. International Journal of Antimicrobial Agents. In Press.

8. Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282. [Epub ahead of print]

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There are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present clinical management includes infection prevention and control measures and supportive care, including supplementary oxygen and mechanical ventilatory support when indicated.

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Observer

Even at their most effective – and draconian – containment strategies have only slowed the spread of the respiratory disease Covid-19. With the World

Health Organization finally declaring a pandemic, all eyes have turned to the prospect of a vaccine, because only a vaccine can prevent people from getting sick.

About 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals. The first of these – produced by Boston-based biotech firm Moderna – will enter human trials imminently.

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As of today, there is still  no cure for the virus, nor a specific treatment, but several companies are working to develop a proper vaccine and proper treatment. As of now, some firms are currently relying on already existing medications or drugs that are used to treat other infectious diseases. One of them includes the drug, Remdesivir, a drug created by Gilead Sciences, and was originally used to treat Ebola and other diseases. Officials at the WHO have considered the drug as being the most potentially effective treatment for COVID-19. The WHO has already began clinical trials for Remdesivir by testing it on patients in Spain and Norway. The other two drugs, Kaletra (A HIV medication) and Kevzara (a rheumatoid arthritis treatment) may also be effective in treating the virus.

https://www.cnn.com/2020/03/30/investing/coronavirus-covid-19-vaccines-drugs/index.htm

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Scientists are breaking speed records in their race to develop treatments for COVID-19. Some are panning through old molecules in hope to find new drugs. Others are already applying the latest breakthroughs in synthetic biology to engineer sophisticated treatments and vaccines. The progress yo develop a treatment for COVID-19 is moving unprecedentedly and breaking historic records every week. Malarial medicine chloroquine has been seen as a possible miracle drug against COVID-19 and 3 million tablets of that substance have been shipped to the U.S last week

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A projected timeline for treatment and prevention of the novel coronavirus. Although we are living ... [+]
SynBioBeta

Scientists are breaking speed records in their race to develop treatments for the new coronavirus. Some are panning through old molecules hoping to find effective drugs. Others are applying the latest breakthroughs in synthetic biology to engineer sophisticated treatments and vaccines.

To provide a big-picture perspective, SynBioBeta and Leaps by Bayer have partnered to help visualize the overall progress of the research community. At the heart of the project is an infographic showing the timeline to the various treatments and preventions (click here to download it). It's based on data from The Milken Institute, which recently released a detailed tracker to monitor the progress of each of the more than 60 known COVID-19 treatments and preventions currently in development.

One takeaway: the progress to develop coronavirus treatments and preventions is moving at an unprecedented pace, with historic records being broken nearly every week.

"The crisis response from the global biotech community has been truly inspiring," says Juergen Eckhardt, SVP and Head of Leaps by Bayer, a unit of Bayer AG that leads impact investments into solutions to some of today's biggest challenges in health and agriculture. "We are excited to partner on this visual timeline to help a broader audience understand how and when scientific innovation may bring us through this deeply challenging time".

COVID19: Projected timeline for treatment and prevention. Three paths: pre-existing drugs, antibody ... [+]
SynBioBeta

There are standard stages to getting a drug approved. In Phase 1 trials, a drug's safety is assessed in a small group of healthy subjects. In later stages (Phase II & III), efficacy is measured in a larger number of people, often versus a placebo. The situation with COVID-19 is predicted to become so dire so quickly, however, that many are looking to fast-track testing. This could include granting experimental drugs 'expanded access,' for compassionate use, which would allow physicians to give them to patients who are critically ill before testing is complete.

Repurposing Existing Drugs

The fastest way to safely stop COVID-19 would be to discover that an already-approved medication works against it. Repurposed drugs do not require the same extensive testing as novel medicines and may already be available in large quantities. The Milken Institute's tracker identifies 7 candidate drugs in this category.

There are hundreds if not thousands of other FDA-approved drugs on the market that are already proven safe in humans and that may have treatment potential against COVID-19, so many scientists are rapidly screening the known drug arsenal in hopes of discovering an effective compound.

Anti-Coronavirus Antibodies

Antibodies are proteins that are a natural part of the human immune system. They work around the clock in blood to block viruses and more. The problem at the moment is that because the novel coronavirus (known as SARS-CoV-2) is new, no one has had time to develop antibodies against it. No one, that is, except those who have recovered from COVID-19.

Antibodies taken from those people could help patients who are still infected. Such patient-to-patient transfers can be performed without extensive testing or lengthy approval processes so long as standard protocols are followed. It is yet unknown whether this treatment option will work for COVID-19, nor whether there will be enough recovered donors to deal with the infection at scale.

"AbCellera's platform has delivered, with unprecedented speed, by far the world's largest panel of anti-SAR-CoV-2 antibodies," said Carl Hansen, Ph.D., CEO of AbCellera, in a statement. "In 11 days, we've discovered hundreds of antibodies against the SARS-CoV-2 virus responsible for the current outbreak, moved into functional testing with global experts in virology, and signed a co-development agreement with one of the world's leading biopharmaceutical companies. We're deeply impressed with the speed and agility of Lilly's response to this global challenge. Together, our teams are committed to delivering a countermeasure to stop the outbreak."

"Normally this would be a five year program," Crowe told me. But in the rapid process his team is following, animal studies could be done in as fast as two months.

This morning, Berkeley Lights announced a Global Emerging Pathogen Antibody Discovery Consortium (GEPAD) to attack COVID-19 and other viruses. It is partnering with Vanderbilt University, La Jolla Institute for Immunology, and Emory University to accelerate the work above to the broader research community.

Printing DNA Has Never Been So Important

"Our mission is to provide the raw material needed for biologists to make breakthroughs," said Twist's CEO Emily Leproust. "If DNA is needed, we want to make it, quickly and perfectly"

Nelson continued, "In a matter of a day or two, we have built the genes thought to be critical to the development of successful vaccines against SARS-CoV-2." SGI-DNA has made them available in the form of different genetic libraries, which researchers can use to find "druggable" targets in a matter of hours, dramatically accelerating the time to market for therapeutics and vaccines.

Of Mice, Men, and AI

Beyond searching for antibodies in recovered patients, biotechnologists have other tricks up their sleeves.

One approach involves genetically engineering laboratory mice to mimic the human immune system. These animals can then be presented with the virus or parts of the virus and allowed to recover. The hope is that their B cells would then produce effective antibodies. Because this happens in a controlled setting, biologists can better understand and engineer the process.

"We believe broadly neutralizing antibodies with engineered biophysical properties will become key weapons to win the war against all coronaviruses" said Jake Glanville, CEO of Distributed Bio.

Vaccines for COVID-19

Vaccines work by simulating infection, which allows the body to mount its own defense against a virus. Effective vaccines take time to develop, and they can take even longer to test. But recent progress in biotechnology is again accelerating these efforts.

Accelerating Progress

These programs show a massive focus on a common enemy, and a coming together of disparate firms.

Ginkgo Bioworks, a giant in the emerging field of synthetic biology, has announced a $25 million fund to help spur even more collaboration. The company is offering its laboratory equipment and know-how to anyone with a good idea of how to stop COVID-19. "We don't want any scientists to have to wait. The pandemic has already arrived, so the time for rapid prototyping and scale-up is right now," said Jason Kelly, CEO of Ginkgo.

These efforts-and the infographic above-should give you hope. Although we are all now living in uncertain times, we are also witnessing one of the greatest moments in the history of science.

"It's a terrible time, and simultaneously a fantastic time to see the global science community working together to conquer this very hard and challenging disease," said Berkeley Lights CEO Eric Hobbs. "We are also learning and developing the tools and technologies to ensure that we can react faster to the next threat, so that we don't get to this point again in the future."
Thank you to and Kevin Costa for additional research and reporting in this article. I'm the founder of SynBioBeta, and some of the companies that I write about-including Leaps by Bayer, Mammoth Biosciences, Distributed Bio, Twist Bioscience, SGI-DNA, Genscript, Berkeley Lights, and Ginkgo Bioworks-are sponsors of the SynBioBeta conference and weekly digest - here's the full list of SynBioBeta sponsors.

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Timeline Shows 3 Paths To COVID-19 Treatment And Prevention (INFOGRAPHIC)

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Scientists are breaking speed records in their race to develop treatments for the new coronavirus. Some are panning through old molecules hoping to find effective drugs. Others are applying the latest breakthroughs in synthetic biology to engineer sophisticated treatments and vaccines.

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The mysterious coronavirus outbreak in the Chinese city Wuhan, now termed as COVID-19, and its fast spread to many other countries, endangers thousands of lives. The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19. Donald Trump, had announced on 19 March that chloroquine and hydroxychloroquine/Plaquenil, used to treat malaria and arthritis, were approved by the FDA to be tested as a treatment for COVID-19. The National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, as a treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients.
Sources: https://www.clinicaltrialsarena.com/analysis/coronavirus-mers-cov-drugs/

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Since there is currently no cure or vaccine for the coronavirus, scientists are searching for a fast solution in the antibodies in the blood of people who have recovered. This week in dozens of medical centers across the United States, researchers will start drawing blood from COVID-19 survivors, who have antibodies their bodies made to fight the disease. They then isolate the plasma containing the antibodies. This process is called “convalescent plasma therapy,” and their antibodies will be transferred to others, either to protect them against getting infected or to boost the immune systems of those who are already sick.

This is a highly experimental therapy, and hasn't been proven to work against COVID-19 yet, but preliminary research from China suggested that it has helped a small group of patients recover. It’s also had some success in past infectious disease outbreaks, including in fighting the SARS outbreak.

Sources:
https://www.fiercebiotech.com/biotech/gigagen-jumps-into-covid-19-arena-polyclonal-antibodies

https://www.npr.org/sections/health-shots/2020/03/26/822003826/how-monoclonal-antibodies-might-prove-useful-against-the-coronavirus

https://www.buzzfeednews.com/article/stephaniemlee/coronavirus-plasma-therapy-blood

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Studies have shown that anti-malarial drug chloroquine has been proven to improve patient outcome, and this emergency alternative has already been given the thumbs-up from President Donald Trump and Tesla and SpaceX CEO Elon Musk. Recently though, research has been found to support the use of hydroxychloroquine, a "less toxic derivative of the drug." A study conducted by French doctors has shown that combining hydroxychloroquine  with azithromycin can also yield positive patient outcomes. However, as Gaeten Burgio, a medical researcher at Australian National University has made clear, the current results are "inconclusive" and "there are no clear indications that chloroquine or hydroxychloroquine are a treatment option." Essentially, like with all new drug treatment options, it will take time and additional clinical trials before this can be determined to be a legitimate treatment for COVID-19.

https://www.cnet.com/how-to/coronavirus-medicine-vaccines-chloroquine-and-drugs-to-treat-covid-19/#chloroquine

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Scientist are currently using a drug called Tocilizumab. This drug is typically used to treat adults with moderate to severe rheumatoid arthritis. Chinese doctors have used this drug to prevent an overreaction of the immune system that has led to organ failure and death in COVID 19 patients. Tocilizumab is expected to be apart of a clinical trial that will include 188 coronavirus patients and running until May 10th.

Sources:
https://www.nbcnews.com/health/health-news/here-are-some-existing-drugs-may-be-repurposed-treat-coronavirus-n1162021

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Currently, an anti-malaria drug called Hydroxychloroquine is being tested as a possible treatment for COVID-19. President Trump hopes to find out whether or not the drug is effective in the next three days. The drug has been used in France for 36 coronavirus patients and was found to relieve the patients from the virus at a high rate. Although, it must go through numerous clinical trials to ensure its safety and reliability, the drug proves to be a promising discovery.

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President Donald Trump said U.S. health officials should have a "good idea" whether an anti-malaria drug being tested as a treatment for COVID-19 is effective in fighting the coronavirus in "the next three days."

"Hydroxychloroquine is something that I have been pushing very hard," Trump said Monday morning during an interview on Fox News. "I think we're going to have a good idea over the next three days because it's been used now in New York at my request -- 1,100 people. It's been used. I think that's better than testing it in a laboratory. But the doctors tell me no."

There are no proven therapies for the treatment of COVID-19 and U.S. health officials expect a vaccine could take 12 to 18 months.

New York state last week began the first large-scale clinical trial using a combination of chloroquine and Azithromycin to treat the coronavirus after the Food and Drug Administration fast-tracked the approval process.

Trump has repeatedly touted chloroquine and hydroxychloroquine as a "game-changer" even though the drugs have not been put through rigorous clinical trials to fight CV-19, which has infected more than 730,000 people worldwide in three months. Trump directed the FDA to examine whether the drugs can be used to prevent or treat the coronavirus earlier this month.

Chloroquine has gained a lot of attention after a small study of 36 COVID-19 patients published March 17 in France found that most patients taking the drug cleared the coronavirus from their system a lot faster than the control group. Adding Azithromycin, commonly known as a Z-Pak, to the mix "was significantly more efficient for virus elimination," the researchers said. A small study in China also found that combining chloroquine with Azithromycin was "found to be more potent than chloroquine."

To pass the FDA's muster, and win approval for widespread use, chloroquine and Azithromycin will need to undergo rigorous clinical trials with thousands of participants - not a couple dozen, according to the agency's guidelines. Early-stage, or phase 1 trials, typically take several months, according to the FDA.

Prominent U.S. health officials, including the National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci and FDA Commissioner Stephen Hahn, have previously down played Trump's claims about the drugs.

Hahn, who is also a physician, said it was "important not to provide false hope."

At a briefing earlier this month, Fauci said signs of the effectiveness of the drugs were "anecdotal" and said, "you really can't make a definitive statement."

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Trump says US officials should have 'good idea' if malaria drug works on coronavirus in three days

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President Donald Trump said U.S. health officials should have a "good idea" whether an anti-malaria drug being tested as a treatment for COVID-19 is effective in fighting the coronavirus in "the next three days." "Hydroxychloroquine is something that I have been pushing very hard," Trump said Monday morning during an interview on Fox News.

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Scientists had recently studied chloroquine, an anti-malarial drug, in the treatment of COVID19. This drug had been used in the past to treat autoimmune diseases, and had shown antiviral tendencies. However, the efficiency and safety of chloroquine regarding the SARS-CoV-2 (the 2019 coronavirus) is unclear. Chloroquine have been discovered and tested through various method such as utilizing articles about the virus through PubMed and EMBASE database, as well as researching clinical trials. Around 234 sources were found through these database, along with 23 clinical trials were tested around the world. Until today, besides the chloroquine, scientists are still actively working to find/test different cures to the COVID19.

SOURCES:

https://www.sciencedirect.com/science/article/pii/S0883944120303907?via%3Dihub

https://www.sciencedirect.com/science/article/pii/S0166354220301145?via%3Dihub

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Gimsilumab by Roivant Sciences is a clinical-stage, human monoclonal antibody. This is being tested for the COVID-19 virus, since the drug targets granulocyte-macrophage colony stimulating factor, which reduces lung damage and reduces morality rate of patients dealing with the COVID-19 virus.
Sources:
https://www.clinicaltrialsarena.com/analysis/coronavirus-mers-cov-drugs/

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See all the wonderful things (Student) Susan.V1 has made

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Favipiravir, and known as Favivilar, is a flu drug that is currently being used to treat COVID-19. There is also a drug called Fusogenix DNA vaccine created by Entos Pharmaceuticals for COVID-19 infections opposed to COVID-19 itself. A bunch of drugs like these are helpful in defeating COVID-19 while a vaccine or cure is researched as they can help the patient overcome the virus and have a greater chance of survival.
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/coronavirus-disease-2019-covid-19-frequently-asked-questions

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Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.

Visit our COVID-19 microsite for the latest coronavirus news, analysis and updates

Follow the updates on coronavirus (COVID-19):

Countries affected by the coronavirus

List of coronavirus suspected countries

Coronavirus (2019-nCoV) outbreak in Wuhan

Coronavirus: timeline of events and latest updates

The mysterious coronavirus outbreak in the Chinese city Wuhan, now termed as COVID-19, and its fast spread to many other countries, endangers thousands of lives. The pandemic has catalysed the development of novel coronavirus vaccines across the biotech industry, both by pharmaceutical companies and research organisations such as the National Institutes of Health (NIH), US.

The first COVID-19 vaccine in China is expected to be ready for clinical trials by the end of April, according to Xu Nanping, China's vice-minister of science and technology. Inovio Pharmaceuticals plans to begin clinical trials on a coronavirus vaccine in April this year.

Health officials from WHO have noted that Gilead's remdesivir has demonstrated efficacy in treating the coronavirus infection.

Chloroquine approved for emergency use by US FDA

The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19.

The President of the United States, Donald Trump, had announced on 19 March that chloroquine and hydroxychloroquine/Plaquenil, used to treat malaria and arthritis, were approved by the FDA to be tested as a treatment for COVID-19.

Chloroquine is being tested in various clinical trials conducted by government agencies and academic institutions. Other antivirals drugs are also planned to be fast-tracked for testing for coronavirus.

Favilavir, the first approved coronavirus drug in China

The National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, as a treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province.

Pharmaceutical companies involved in developing coronavirus drugs/vaccines

Here is a list of the major coronavirus drugs that pharmaceutical companies across the world are developing that have the potential to become major coronavirus vaccines or antivirals for treating the contagious coronavirus infection.

Novel coronavirus vaccines

Listed below are the coronavirus vaccines in various stages of development, across the world.

Fusogenix DNA vaccine by Entos Pharmaceuticals

Entos Pharmaceuticals is developing Fusogenix DNA vaccine developed using the Fusogenix drug delivery platform to prevent COVID-19 infections. Fusogenix drug delivery platform is a proteo-lipid vehicle that introduces genetic payload directly into the cells.

Entos is working on developing an optimised payload containing multiple protein epitopes derived from SARS-COV-2 proteins, which will stimulate an immune response in the body to prevent COVID-19 infection.

ChAdOx1 nCoV-19 by University of Oxford

The University of Oxford's ChAdOx1 nCoV-19 is an adenovirus vaccine vector developed by the university's Jenner Institute. The university is testing the vaccine in a clinical trial planned to be conducted in the Thames Valley Region.

Approximately 510 volunteers aged between 18 years and 55 years will be enrolled for the study.

Gimsilumab by Roivant Sciences

Roivant Sciences is advancing the development of Gimsilumab a clinical-stage, human monoclonal antibody. The drug targets granulocyte-macrophage colony stimulating factor (GM-CSF), which is a pro-inflammatory cytokine found in high levels in the serum of COVID-19 patients.

Targeting GM-CSF is expected to reduce lung damage and reduce mortality rate in COVID-19 patients.

AdCOVID by Altimmune

Altimmune has collaborated with the University of Alabama at Birmingham (UAB) to develop a single dose intranasal vaccine for COVID-19 named AdCOVID. The company is currently carrying out immunogenicity studies after, which phase one clinical trial material will be developed.

Altimmune and UAB will work with researchers to conduct preclinical animal studies and phase one clinical trial in the third quarter of 2020.

I-Mab Biopharma is developed TJM2, a neutralising antibody, as a treatment for cytokine storm in patients suffering from a severe case of coronavirus infection. The drug targets the human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is responsible for acute and chronic inflammation.

The company will commence development after receiving approval for the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA).

Coronavirus vaccine by Medicago

Medicago is developing drug candidates against COVID-19 after having produced Virus-Like Particles (VLP) of the coronavirus. The company has formed a collaboration with Laval University's Infectious Disease Research Centre to develop antibodies against SARS-CoV-2.

The company's research activities are being partly funded by the Canadian Institutes for Health Research (CIHR).

AT-100 by Airway Therapeutics

Airway Therapeutics is exploring its novel human recombinant protein named AT-100 (rhSP-D) as a treatment for coronavirus. The company has announced a filing with the Respiratory Diseases Branch of the National Institutes of Health to evaluate the drug.

AT-100 has shown efficacy in preclinical studies in reducing inflammation and infection in the lungs, while also generating an immune response against various respiratory diseases.

TZLS-501 by Tiziana Life Sciences

Tiziana Life Sciences is developing its monoclonal antibody named TZLS-501 for the treatment of COVID-19. TZLS-501 is a human anti-interleukin-6 receptor (IL-6R), which helps in preventing lung damage and elevated levels of IL-6.

The drug works by binding to IL-6R and depleting the amount of IL-6 circulating in the body thereby reducing chronic lung inflammation.

OYA1 by OyaGen

OyaGen's OYA1 has shown strong antiviral efficacy against coronavirus in laboratory essays. It was found to be more effective than chlorpromazine HCl in inhibiting SARS-CoV-2 from replicating in cell culture.

OYA1 was earlier approved as an investigational new drug for treating cancer but abandoned due to lack of efficacy. OyaGen plans to conduct further research on the drug to determine the efficacy in treating coronavirus.

BPI-002 by BeyondSpring

BeyondSpring's BPI-002 is a small molecule agent indicated for treating various infections including COVID-19. It has the ability to activate CD4+ helper T cells and CD8+ cytotoxic T cells and generating an immune response in the body.

If combined with another COVID-19 vaccine, the drug has the ability to generate long-term protection against viral infections. BeyondSpring has filed US patent protection for the drug for treating viral infections.

Altimmune's intranasal coronavirus vaccine

An intranasal Covid-19 vaccine is being developed by US-based clinical-stage biopharmaceutical company, Altimmune.

Design and synthesis of the single-dose vaccine have been completed, while animal testing will follow.

The coronavirus vaccine is being developed based on a vaccine technology platform that is similar to NasoVAX, an influenza vaccine developed by Altimmune.

INO-4800 by Inovio Pharmaceuticals and Beijing Advaccine Biotechnology

Inovio Pharmaceuticals has collaborated with Beijing Advaccine Biotechnology Company to advance the development of the former's vaccine, INO-4800, as a novel coronavirus vaccine. The company has started pre-clinical testing for clinical product manufacturing.

The vaccine development is supported by a $9m grant from the Coalition for Epidemic Preparedness Innovations (CEPI).

Inovio announced an accelerated timeline for the development of the vaccine on 03 March. Preclinical trials are ongoing and the design for human clinical trials have been completed. The company has also prepared 3,000 doses for human clinical trials planned to be conducted across the US, China, and South Korea. Plans for large-scale manufacturing have also been developed.

Human clinical trials in 30 healthy volunteers are expected to commence in April 2020 in the US, followed by China, and South Korea. A phase one clinical trial is planned to be conducted in parallel in China, by Beijing Advaccine. Results from the clinical trials are expected to be available in September 2020.

Inovio aims to produce one million doses of the vaccine by the end of 2020 to perform additional clinical trials or emergency use.

NP-120 (Ifenprodil) by Algernon Pharmaceuticals

Algernon Pharmaceuticals has announced that it is exploring its NP-120 (Ifenprodil) as a potential treatment COVID-19. Ifenprodil is an N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist sold under the brand name Cerocal. It has demonstrated efficacy in improving survivability in mice infected with H5N1.

APN01 by University of British Columbia and APEIRON Biologics

A drug candidate developed by APEIRON Biologics named APN01 is being tested in China in a phase one pilot trial as a treatment for COVID-19. APN01 is based on research conducted by a professor at the University of British Columbia for treating SARS. The research revealed that the ACE2 protein was the main receptor for the SARS virus.

The clinical trial will test the drug's efficacy in reducing the viral load in patients. Data from the trial will be used to determine if additional clinical trials are required to be conducted in larger number of patients.

mRNA-1273 vaccine by Moderna and Vaccine Research Center

Moderna and the Vaccine Research Center, a unit of the National Institute of Allergy and Infectious Diseases (NIAID), have collaborated to develop a vaccine for coronavirus. The vaccine targets the Spike (S) protein of the coronavirus.

The first vials of the vaccine have been manufactured at Moderna's Massachusetts manufacturing plant and shipped to NIAID for phase one human clinical trial. The trial began on 16 March at the Kaiser Permanente Washington Health Research Institute in Seattle, Washington. A total of 45 males and females aged between 18 and 45 have been enrolled for the trial.

The participants will be divided into three cohorts who will be administered 25 microgram (mcg), 100mcg or 250mcg dose 28 days apart.

Avian Coronavirus Infectious Bronchitis Virus (IBV) vaccine by MIGAL Research Institute

The MIGAL Research Institute in Israel announced that an Infectious Bronchitis Virus (IBV) vaccine developed to treat avian coronavirus has been modified to treat COVID-19. The vaccine has demonstrated efficacy in pre-clinical trials conducted by the Volcani Institute.

The IBV vaccine was developed after four years of research and has high genetic similarity to the human coronavirus. The institute has genetically modified the vaccine to treat COVID-19 and will be available in the oral form.

The institute is currently exploring potential partners for producing the vaccine in the next eight to ten weeks and obtaining the necessary safety approvals for in-vivo testing.

TNX-1800 by Tonix Pharmaceuticals

Tonix Pharmaceuticals has partnered with Southern Research, a non-profit research organisation, to develop a vaccine for coronavirus named TNX-1800. The vaccine is a modified horsepox virus developed using Tonix's proprietary horsepox vaccine platform.

TNX-1800 is designed to express a protein derived from the virus that causes the coronavirus infection. Southern Research will be responsible for evaluating the efficacy of the vaccine, under the partnership.

Brilacidin by Innovation Pharmaceuticals

Innovation Pharmaceuticals announced that it is evaluating Brilacidin, a defensin mimetic drug candidate, as a potential treatment for coronavirus. Brilacidin has shown antibacterial, anti-inflammatory and immunomodulatory properties in several clinical trials.

The company is planning to explore research collaborations and seek federal grants to develop the coronavirus drug. It is already investigating the drug for inflammatory bowel disease and oral mucositis in cancer patients.

Innovation has signed two material transfer agreements with a university in the US and 12 biocontainment labs in the US for evaluation of Brilacidin as a treatment for COVID-19. One of the biocontainment labs is scheduled to commence testing of the drug in the third week of March.

Recombinant subunit vaccine by Clover Biopharmaceuticals

Clover Biopharmaceuticals is developing a recombinant subunit vaccine using its patented Trimer-Tag © technology. The company is developing the vaccine based on the trimeric S protein (S-Trimer) of the COVID-19 coronavirus, which is responsible for binding with the host cell and causing a viral infection.

Using Trimer-Tag © technology, Clover successfully produced the subunit vaccine in a mammalian cell-culture based expression system on 10 February. The company also identified antigen-specific antibody in the serum of fully recovered patients who were previously infected by the virus.

A highly purified form of the S-Trimer vaccine is expected to be available in six to eight weeks for performing pre-clinical studies. The company is equipped with in-house cGMP biomanufacturing capabilities to scale-up production if the vaccine is proven to be successful.

Clover is also collaborating with GSK to develop a vaccine using the latter's pandemic adjuvant system.

Vaxart's coronavirus vaccine

Vaxart is developing an oral recombinant vaccine in tablet formulation using its proprietary oral vaccine platform, VAAST.

The company plans to develop vaccines based on the published genome of 2019-nCOV to be tested in pre-clinical models for mucosal and systemic immune responses.

CytoDyn-leronlimab

CytoDyn is examining leronlimab (PRO 140), a CCR5 antagonist, as a potential coronavirus drug.

The drug is already being investigated in phase two clinical trials as a treatment for HIV and has been awarded fast-track approval status by the United States Food and Drug Administration.

Linear DNA Vaccine by Applied DNA Sciences and Takis Biotech

Applied DNA Sciences' subsidiary LineaRx and Takis Biotech formed a joint venture on 07 February to develop a linear DNA vaccine as a treatment for coronavirus. The JV will use Polymerase Chain Reaction (PCR)-based DNA manufacturing technology to develop the vaccine.

The PCR technology offers several advantages including high purity, increased production speed, and absence of antibiotics and bacterial contaminants. Further, the vaccine gene developed through this technology can be effective without being inserted into the patient's genome.

The design for four DNA vaccine candidates is expected to be produced using the PCR technology for carrying out animal testing. The design of one of the vaccine candidates is based on the entire spike gene of the coronavirus, while the remaining are designed based on the antigenic portions of the protein.

BXT-25 by BIOXYTRAN to treat late-stage acute respiratory distress syndrome (ARDS)

BIOXYTRAN announced that it is exploring partners to develop its lead drug candidate, BX-25, as a treatment for Acute Respiratory Distress Syndrome (ARDS) in late-stage patients infected with the coronavirus. The diffusion of oxygen to the blood is comprised in patients suffering from ARDS leading to fluid build-up in the lungs.

BX-25 is designed to be 5,000 times smaller than blood cells and efficiently transport oxygen through the body for a period of nine hours before being processed by the liver. The drug can help in supplying oxygen to the vital organs and enable the patient to recover and survive.

MERS CoV vaccines for coronavirus

Novavax's MERS coronavirus vaccine candidate

Novavax developed a novel Middle East Respiratory Syndrome (MERS) coronavirus vaccine candidate in 2013, post the identification of the first MERS coronavirus ((MERS-CoV) in Saudi Arabia in 2012. It is a crucial target for vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI) and is a priority disease for the World Health Organisation (WHO).

The candidate is designed to primarily bind to the major surface S-protein and developed using the company's recombinant nanoparticle vaccine technology. Tested along with the Novavax's proprietary adjuvant Matrix-M ™, it inhibited infection by inducing immune responses in the laboratory studies.

Novavax has received $4m in funding from CEPI to advance the development of the vaccine. The company has produced several nanoparticle vaccine candidates for testing in animal models and aims to carry out human trials in 2020.

The MERS coronavirus is related to the severe acute respiratory syndrome (SARS) coronavirus, for which the company had previously developed a recombinant nanoparticle vaccine candidate.

Inovio Pharma's INO-4700

The investigational DNA immunotherapy, INO-4700 (GLS-5300) is being developed by Inovio in partnership with GeneOne Life Science. It is delivered as vaccine intramuscularly, using the Cellectra ® delivery device.

The company has received a $5m grant from the Bill and Mellinda Gates foundation to accelerate the development of the Cellectra ® delivery device.

The vaccine was well-tolerated and demonstrated high immune responses against the MERS-CoV in 94% of patients in the early-stage clinical trial in July 2019.

It also generated broad-based T cell responses in 88% of the subjects.

"Research organisations such as the National Institutes of Health (NIH), US are also developing a vaccine for the coronavirus."

Coronavirus drugs

The novel coronavirus drugs in various stages of development globally are listed below.

Remdesivir (GS-5734) by Gilead Sciences

An ebola drug developed by Gilead Sciences that was found to be ineffective is now being tested in two phase III randomised clinical trials in Asian countries.

The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan, the epicentre of the novel coronavirus outbreak. The results from the trials are expected to be available over the next few weeks.

According to a report by The New England Journal of Medicine (NEJM), remdesivir, when administered to a coronavirus patient in the US, appeared to have improved the clinical condition.

The University of Nebraska Medical Center is also carrying out clinical trials to test the safety and efficacy of the drug. The first patient to be administered the drug is an evacuee from the Diamond Princess cruise ship.

Actemra by Roche to treat coronavirus-related complications

China approved the use of Roche's Actemra for the treatment of severe complications related to coronavirus. Drugs like Actemra have the ability to prevent cytokine storms or overreaction of the immune system, which is considered as the main reason behind organ failure leading to death in some coronavirus patients.

Actemra is also being evaluated in a clinical trial in China, which is expected to enroll 188 coronavirus patients. The clinical trial is expected to be conducted until May 10.

Biocryst Pharma's Galidesivir, a potential antiviral for coronavirus treatment

The antiviral drug Galidesivir (BCX4430) has shown broad-spectrum activity against a wide range of pathogens including coronavirus. It is a nucleoside RNA polymerase inhibitor that disrupts the process of viral replication.

The drug has already shown survival benefits in patients against deadly viruses such as Ebola, Zika, Marburg, and Yellow fever.

Galidesivir is currently in advanced development stage under the Animal Rule to combat multiple potential viral threats including coronaviruses, flaviviruses filoviruses, paramyxoviruses, togaviruses, bunyaviruses, and arenaviruses.

Regeneron's REGN3048-3051 and Kevzara

Discovered by Regeneron, the combination of neutralising monoclonal antibodies REGN3048 and REGN3051 is being studied against coronavirus infection in a first-in-human clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The safety and tolerability of the drug will be studied in 48 patients.

Both the antibodies bind to S-protein of MERS coronavirus. The intravenous administration of the drug in the mouse model of MERS resulted in the high-level neutralisation of the MERS coronavirus in circulating blood with reduced viral loads in the lungs.

Regeneron has partnered with Sanofi to evaluated Kevzara, a fully-human monoclonal antibody, in a phase two/three clinical trial in patients with severe COVID-19 infection. Kevzara is approved for the treatment of rheumatoid arthritis and is known to block the interleukin-6 (IL-6) pathway, which causes an overactive inflammatory response in the lungs of COVID-19 patients.

SNG001 by Synairgen Research

Synairgen Research's SNG001, an inhaled drug, is planned to be tested by the University of Southampton to treat asthma, chronic obstructive pulmonary disease and lower respiratory tract illnesses caused by coronavirus.

SNG001 is a formulation of naturally occurring Interferon-β, which is administered through a nebuliser and is delivered directly to the lungs to reduce the severity of the infection caused by coronavirus.

AmnioBoost by Lattice Biologics

Lattice Biologics is exploring the efficacy of its amniotic fluid concentrate, AmnioBoost, in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients. AmnioBoost was developed for chronic adult inflammatory conditions such as osteoarthritis.

The drug has shown efficacy in reducing the inflammatory conditions caused by several diseases including coronavirus. It reduces the production of pro-inflammatory cytokines while boosting the production of anti-inflammatory cytokines.

Other companies developing coronavirus vaccines/drugs

Companies such as Inovio Pharmaceuticals, Moderna, and Novavax have been reported to be developing vaccines. A total of 30 therapies are being tested, including few traditional medicines for coronavirus treatment by Chinese scientists. Chloroquine phosphate has shown efficacy in treating symptoms of the disease, among the 30 therapies. Patients administered with the drug achieved a better drop in fever and shorter recovery time in clinical trials being conducted in hospitals in the Guangdong province and Hunan province.

Enanta Pharmaceuticals

Enanta Pharmaceuticals has announced its plans to develop antiviral drug candidates to treat COVID-19 patients. The company is testing compounds from its existing antiviral compound library for potential efficacy in treating COVID-19. It has also launched a drug discovery programme to develop direct-acting drug candidates to treat COVID-19.

Predictive Oncology

Predictive Oncology has launched an AI Platform for the discovery and development of vaccines against coronavirus. The company has signed an agreement with InventaBioTech to acquire Soluble Therapeutics, which provides it with access to the HSC TM Technology.

Predictive will use the HSC TM Technology along with its predictive modeling platform to deploy an AI discovery platform that can screen the ideal combination of additives and excipients for protein formulations.

Emergent BioSolutions

Emergent BioSolutions is developing two plasma-derived product candidates or hyperimmunes using its hyperimmune platforms for the treatment of coronavirus. The hyperimmune platforms have been used previously for the development of several approved products including vaccines for smallpox, botulism, and anthrax.

The hyperimmunes are polyclonal antibodies derived from plasma, which are capable of generating an immune response and protecting against infection. Product candidate derived from human plasma is named COVID-HIG, while COVID-EIG is derived from equine plasma. Both will be explored for the treatment of patients with a severe case of infection.

Integral Molecular

Integral Molecular has launched a vaccine programme using its two technology platforms including Shotgun Mutagenesis Epitope Mapping and the Membrane Proteome Array. The technologies will help in understanding the human immune response to the coronavirus and isolate the cellular receptors that enable the virus to spread quickly.

The Shotgun technology helps in identifying more than 1,000 binding sites for antibodies, while the Membrane Proteome Array technology is capable of identifying the receptors through which viruses infect cells.

CEL-SCI

CEL-SCI is developing immunotherapy against COVID-19 using its proprietary LEAPS peptide technology, which utilises conserved areas of the coronavirus proteins to generate T-cell responses and reduce viral load. The technology can also be used to develop immunotherapeutic peptides with both antiviral and anti-inflammatory properties.

The peptides developed using this technology can help in reducing tissue damage from inflammation caused due to lung infection, which is a major cause of mortality in elderly patients.

AJ Vaccines

AJ Vaccines has launched the development of a vaccine against COVID-19. The company will use the latest technology to develop antigens that can mimic the native structures of the virus. The vaccine will be capable of inducing a strong immune response in the body thereby protecting against the infection.

Takeda Pharmaceutical Company

Takeda Pharmaceutical Company has announced plans to develop a plasma-derived therapy against coronavirus. The anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) therapy will be designed to treat high-risk patients. The H-IG therapy includes concentrated pathogen-specific antibodies derived from plasma of recovered patients. These antibodies have the potential to generate an immune response when injected into a new patient.

Heat Biologics

Heat Biologics has announced plans to develop a vaccine to treat or prevent coronavirus infection using its proprietary gp96 vaccine platform. The technology is capable of reprogramming live cells to produce antigens that can bind to the gp96 protein and generate an immune response against those antigens.

Pfizer

Pfizer announced that it has identified certain under development antiviral compounds that may be effective in treating coronavirus. The company is planning to partner with a third party to screen and identify potential compounds by the end of March and begin testing in April.

Mateon Therapeutics

Mateon Therapeutics has launched an antiviral response programme to develop coronavirus treatments using its therapeutic and artificial intelligence (AI) platforms. It has also established a division, which will adopt a multi-modal approach to developing COVID-19 treatments as well as other future zootonic outbreaks.

Hong Kong University of Science and Technology

The Hong Kong University of Science and Technology has identified several vaccine targets, which can be developed as a treatment for coronavirus. Researchers at the university have identified B-cell and T-cell epitopes, which are capable of generating an immune response against the SARS virus and a similar response against the coronavirus.

Some of the epitopes identified may be capable of generating an immune response specifically against COVID-19.

Vaccine by Generex

Generex has announced that it is developing a COVID-19 vaccine following a contract from a Chinese consortium comprising of China Technology Exchange, Beijing Zhonghua Investment Fund Management, Biology Institute of Shandong Academy of Sciences and Sinotek-Advocates International Industry Development.

The company will utilise its Ii-Key immune system activation technology to produce a COVID-19 peptide for human clinical trials.

Generex will receive an upfront payment of $1m to commence the groundwork for the vaccine development and $5m licensing fee for its Ii-Key technology. It is also eligible to receive a 20% royalty on every dose of vaccine produced under the contract.

Coronavirus drugs by Columbia University

Researchers at Columbia University have been awarded a $2.1m grant by the Jack Ma Foundation to develop a coronavirus cure. Four different teams at the university will adopt various approaches towards the development of a vaccine against coronavirus.

Vaccine by Tulane University

Tulane University has launched a research programme to identify a potential coronavirus medicine in the form of a vaccine. The university will utilise a grant from the Brown Foundation to carry out the research activities.

Coronavirus vaccine by ImmunoPrecise Antibodies

ImmunoPrecise Antibodies has launched a vaccine and therapeutic antibody programme to develop a vaccine as well as antibodies against COVID-19. The company will use its B Cell Select™ and DeepDisplay™ discovery platforms to therapeutic compounds against the coronavirus.

The company has updated its research efforts and noted that it will be using the PolyTope mAb Therapy TM and EVQLV's artificial intelligence platforms develop a COVID-19 therapy.

Serum Institute of India

Serum Institute of India (SII) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a cure for coronavirus using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022.

Southwest Research Institute

Southwest Research Institute is using its virtual screening called Rhodium to identify potential drug candidates for treating coronavirus from more than two million drug compounds. The most promising compounds will be identified for further development.

Zydus Cadila

Zydus Cadila announced the launch of an accelerated research programme to develop a vaccine for COVID-19 using two novel approaches. The first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach. The rMV-based vaccine works by inducing specific neutralising antibodies, which will provide protection from the coronavirus infection.

NanoViricides

NanoViricides, a clinical-stage company, is working on developing a treatment for nCoV-2019 using its nanoviricide ® technology. The company's technology is used to develop ligands that can bind to the virus in the same way as a cognate receptor and attack various points of the virus.

Vir Biotechnology

Vir Biotechnology, a clinical-stage immunology company, announced on 12 February that it has identified two monoclonal antibodies that can bind to the virus that causes COVID-19. The antibodies target the spike (S) protein of the virus by entering through the cellular receptor ACE2.

The company has formed a partnership with WuXi Biologics on 25 February to commercialise the antibodies identified to treat coronavirus. If approved, Wuxi will have the rights to market the therapies in China, while Vir will retain the marketing rights in other countries.

Vir has also partnered with Alnylam Pharmaceuticals to identify siRNA candidates targeting SARS-CoV-2. It has formed another partnership with Biogen for cell line and process development and manufacturing of the antibodies.

HIV drugs for coronavirus treatment

Abbvie's HIV protease inhibitor, lopinavir is being studied along with ritonavir for the treatment of MERS and SARS coronaviruses. The repurposed drug is already approved for the treatment of HIV infection under the trade name Kaletra ®.

The combination is listed in the WHO list of essential medicines. Lopinavir is believed to act on the intracellular processes of coronavirus replication and demonstrated reduced mortality in the non-human primates (NHP) model of the MERS.

Lopinavir/ritonavir in combination with ribavirin showed reduced fatality rate and milder disease course during an open clinical trial in patients in the 2003 SARS outbreak.

Cipla is also reportedly planning to repurpose its HIV drug LOPIMUNE, which is a combination of protease inhibitors Lopinavir and Ritonavir, for the treatment of coronavirus.

A licensed generic of Kaletra ®, LOPIMUNE is currently available in packs of 60 tablets each, containing 200mg of Lopinavir and 50mg of Ritonavir.

Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, donated its PREZCOBIX ® HIV medication (darunavir/cobicistat) for use in research activities aimed at finding a treatment for COVID-19.

Darunavir is a protease inhibitor marketed by Janssen. Anecdotal reports suggest darunavir as potentially having antiviral activity against COVID-19. It is, however, currently approved only for use with a boosting agent, and in combination with other antiretrovirals, for the treatment of HIV-1.

Janssen has no in vitro or clinical data to support the use of darunavir as a treatment for COVID-19. The drug is in the process of being evaluated in vitro for any potential activity against the coronavirus.

Further, Janssen has partnered with the Biomedical Advanced Research and Development Authority (BARDA) to expedite the development of a COVID-19 treatment.

The Coronavirus outbreak

The contagious coronavirus outbreak at the end of 2019, which the WHO named as COVID-19 (formerly 2019-nCoV), led to a medical emergency across the world.

Similar infections are caused by human alpha and beta coronaviruses such as 229E, NL63, OC43 and HKU1.

What are the symptoms?

Coronavirus symptoms include those associated with common cold, such as running nose, headache, cough, fever, and sore throat.

Coronavirus transmission

"Coronavirus transmission can happen human-to-human as well as from infected animals such as dogs and cats."

COVID-19 is a betacoronavirus that has origin in bats, according to the Centers for Disease Control and Prevention (CDC).

Believed to have transmitted from animals and reptiles such as snakes, coronaviruses cause respiratory issues such as upper respiratory tract illnesses and lower respiratory illnesses such as pneumonia and bronchitis.

Coronavirus transmission can happen human-to-human as well as from infected animals such as dogs and cats.

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Coronavirus outbreak: Top coronavirus drugs and vaccines in development

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Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.

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As the number of those infected rises, nations are the world are trying to find a cure for this deadly disease. It has been found that Chloroquine and Hydroxychloroquine can be effective with those diagnosed with COVID-19. The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19. Chloroquine was first used as prophylaxis and treatment for malaria. Hydroxychloroquine is a more soluble and less toxic metabolite of chloroquine, which causes fewer side effects and is, therefore, safer.
The ability of  Chloroquine and Hydroxychloroquine to inhibit certain coronaviruses, such as SARS-CoV-1, has been explored with promising results. Both drugs are affordable and widely available internationally. With decades of experience administering these drugs, their safety profiles are well-established. It is likely to take many months for a specific treatment for COVID-19 to become available. As a result, there has been growing interest in the use of Chloroquine and Hydroxychloroquine as potential treatments in the interim.

Sources:
https://www.medicalnewstoday.com/articles/who-launch-trial-testing-4-potential-covid-19-treatments
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https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19

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The World Health Organization (WHO) have launched SOLIDARITY, a giant trial, testing the potential of therapies, old and new, to beat the coronavirus that is causing the current pandemic.

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The WHO have launched SOLIDARITY, a trial to test the four most promising treatments for COVID-19.

In a press briefing last Friday, WHO director-general, Dr. Tedros Adhanom Ghebreyesus, announced the launch of SOLIDARITY, a giant multinational trial for testing therapies that researchers have suggested may be effective against COVID-19.

"That's why WHO [have] launched the SOLIDARITY trial, to generate robust, high quality evidence as fast as possible," Dr. Ghebreyesus said.

"I'm glad that many countries have joined the SOLIDARITY trial that will help us to move with speed and volume. The more countries that sign up to the SOLIDARITY trial and other large studies, the faster we will get results on which drugs work, and the more lives we will be able to save."

- Dr. Tedros Adhanom Ghebreyesus

SOLIDARITY includes research looking at four possible therapeutics: remdesivir; chloroquine and hydroxychloroquine; lopinavir plus ritonavir; and lopinavir plus ritonavir and interferon-beta.

Scientists originally developed remdesivir as a drug to treat Ebola. However, clinical trials later indicated that the compound was insufficiently effective against the virus that causes that disease.

The drug relies on a mechanism that appears to be effective against other viruses, specifically coronaviruses, however.

Research, appearing in Science Translational Medicine in 2017, suggested that remdesivir may be able to fight SARS and MERS.

So, more recently, investigators have started experimenting with the drug to fight SARS-CoV-2, the virus that causes COVID-19.

In one case study from earlier this month, doctors reported that a 35-year-old male from the United States, who received remdesivir after contracting the new coronavirus, started to recover soon after he began the drug. There have since been other reports of people recovering from COVID-19 thanks to this drug.
Remdesivir works by inhibiting a specific enzyme, RNA polymerase, which normally allows the virus to replicate. Without that enzyme, the virus becomes less able to maintain its hold on the body.
Commenting on a preliminary in vitro study, suggesting that remdesivir may be effective against SARS-CoV-2, Dr. Andrew Preston, from the University of Bath in the United Kingdom, explains that the drug "mimics one of the building blocks of the viral genome, but is nonfunctional, causing premature termination of virus genome replication."

Doctors have used chloroquine and hydroxychloroquine as antimalarial drugs for decades, but researchers have recently started arguing that they could repurpose these compounds to fight SARS-CoV-2.
A WHO report from March 13 indicates that "chloroquine has received significant attention in [different] countries as a potentially useful prophylactic [preventive] and curative agent, prompting the need to examine emerging evidence to inform a decision on its potential role."
The report weighed the results of different preliminary studies that tested the potential of chloroquine and hydroxychloroquine in the treatment of COVID-19, and it paved the way for larger trials due to verify the effectiveness of these drugs against the new disease.

In his independent comment, Dr. Preston notes that "[t]he anti-viral effects of chloroquine are thought to derive from two distinct functions."

"In one," he explains, "chloroquine blocks the synthesis of parts of the virus receptors on cells, by inhibiting the addition of certain sugar groups to the cell surface that are recognized by the virus."

"In the second mechanism, following attachment of the virus to the cell surface, it is internalized within a membrane-enclosed compartment," which may ultimately inhibit the virus's replication.

The commentator further observes: "The virus escapes from this to reach the internal environment of the cell in a process that is triggered by a reduction in pH (making more acidic) of this compartment. Chloroquine can increase the intracellular pH (make it more alkaline), and this inhibits the escape of the virus into the cell where it replicates."

Ritonavir and lopinavir are two compounds that doctors administer together as antiretroviral therapy - the therapy that treats HIV infections.
Research from The Lancet in January has suggested that this drug combo may be able to fight SARS-CoV-2 by targeting a specialized molecule that allows both HIV and coronaviruses, such as SARS-CoV and MERS-CoV, to replicate.
However, a trial whose results appeared in The New England Journal of Medicine earlier this month, cast a shadow of doubt upon this drug combo's effectiveness.

In this trial, the researchers found that there was virtually no difference in outcome between patients with COVID-19 who received standard care, and those who received ritonavir and lopinavir.

However, the patients who agreed to join the trial had severe symptoms, which may mean that they received the intervention too late for it to be helpful.

To boost the potential effectiveness of ritonavir and lopinavir, one trial is testing a combination of those two drugs and interferon-beta, a compound doctors use as first-line therapy in the treatment of multiple sclerosis.
The trial - called MIRACLE - is currently testing this experimental treatment with the consent of MERS patients.
Yet another upcoming trial - supported by a U.K.-based pharmaceutical company and not part of the WHO effort - aims to use a specific formulation of interferon-beta on its own in the treatment of COVID-19.

"The idea behind the trial is that, by giving more of this molecule to the lung, this could help reduce the severity of infection with COVID-19, especially in those people who have reduced immune responses to the virus," explains Prof. Ian Hall from the University of Nottingham in the U.K. Prof Hall is not associated with the upcoming trial.

The multinational WHO endeavor, as well as unrelated studies and trials taking place around the world, are all part of international efforts to bring SARS-CoV-2 definitively under control.

"We [...] recognize that there is a desperate need for effective therapeutics. There is, currently, no treatment that has been proven to be effective against COVID-19," emphasized Dr. Ghebreyesus in his press briefing.

Yet, he went on to add, "[i]t's great to see the level of energy now being directed to research against COVID-19."
For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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WHO launch trial testing 4 potential treatments for COVID-19

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The World Health Organization (WHO) have launched SOLIDARITY, a giant trial, testing the potential of therapies, old and new, to beat the coronavirus that is causing the current pandemic. In a press briefing last Friday, WHO director-general, Dr. Tedros Adhanom Ghebreyesus, announced the launch of SOLIDARITY, a giant multinational trial for testing therapies that researchers have suggested may be effective against COVID-19.

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One of the drugs being tested to treat Covid-19 is a japan flu drug called Favipiravir or Avigan. It has been tested in Wuhan and Shenzhen and has been proven effective in treatment.
Chloroquine and hydroxychloroquine have been approved by the U.S. Food ad Drug Administration for the treatment of malaria and lupus, but research suggest it could effectively treat Covid-19