COVID-19 Treatments

COVID-19 Disease Treatments

As of March 30, 2020,  the US Food and Drug Administration (FDA) had not approved any medication for treating people infected with the novel coronavirus SARS-CoV-2, which causes COVID-19 disease in humans.

However, the FDA issued new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS) for treating patients. For drugs subject to REMS with laboratory testing or imaging requirements, healthcare providers should use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies.

They should also communicate with their patients regarding these treatment judgments, including their benefits and risks.

COVID-19 Disease Treatment Protocols

When treating COVID-19 patients, the various disease designations include uncomplicated illness, mild pneumonia, severe pneumonia, acute respiratory distress syndrome, sepsis, and septic shock may apply:

  • Triage: This is the first edition document for SARS-CoV-2 coronavirus, an adaption of WHO Clinical management.
  • Hospital Arrival: Once a COVID-19 patient arrives at a hospital, the CDC's Interim Clinical Guidance for Management of Patients with COVID-19 disease is available.

  • Supportive Care: If you are treating a COVID-19 patient, the CDC published 10 things you can do to manage health issues at home.

March COVID-19 Disease Treatment News

  • March 30, 2020 - BARDA and Johnson & Johnson have expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The Company’s aim is to identify potential treatments against the novel coronavirus. J&J and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.

  • March 30, 2020 - CytoDyn Inc. announced that an additional 3 critically ill COVID-19 disease patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug granted by the U.S. FDA. 

  • March 30, 2020 - Bellerophon Therapeutics, Inc. announced that expanded access treatment with the INOpulse® inhaled nitric oxide system (iNO) was initiated for the 1st time in a patient with a diagnosis of the novel coronavirus disease (COVID-19) at the University of Miami School of Medicine. The treatment follows the recent decision by the U.S. FDA to grant emergency expanded access that allows INOpulse to immediately be used for the treatment of COVID-19 under the care and supervision of their physician.

  • March 29, 2020 - Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit's malaria, lupus and arthritis drug hydroxychloroquine is the company's biggest hope against the coronavirus, Swiss newspaper SonntagsZeitung. On March 26th, Novartis has pledged to donate 130 million doses and is supporting clinical trials needed before the medicine, which U.S. President Donald Trump also has been promoting, can be approved for use against the coronavirus.

  • March 25, 2020 - Vir Biotechnology, Inc. announced that it has identified multiple human monoclonal antibody (mAb) development candidates that neutralize SARS-CoV-2, the virus responsible for COVID-19. The ability of this antibody to neutralize the SARS-CoV-2 live virus has been confirmed in two separate laboratories. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved. Vir believes that the conservation of this epitope will make it more difficult for escape mutants to develop.

  • March 24, 2020 - Aldeyra Therapeutics, Inc. announced that it will begin screening its library of novel reactive aldehyde species (RASP) inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and antiviral activity in the treatment of COVID-19 infection.

  • March 23, 2020 – AlloVir announced the expansion of its research and development collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus-specific T-cell therapies to combat SARS-CoV-2, the virus that causes COVID-19.

  • March 22, 2020 - Gilead Sciences issued a statement on access to Remdesivir outside of clinical trials. To streamline the emergency access process, Gilead is currently in the process of transitioning from individual compassionate use requests to expanded access programs. This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. These programs are currently under rapid development in conjunction with national regulatory authorities worldwide and may vary by region based on local laws and regulations.

  • March 20, 2020 - Teva Pharmaceutical announced the immediate donation of more than 6 million doses of hydroxychloroquine sulfate tablets through wholesalers to hospitals across the U.S. to meet the urgent demand for the medicine as an investigational target to treat COVID-19 disease. Although the product is not currently approved for use in the treatment of COVID-19, it is approved by the U.S. FDA for the treatment of malaria, lupus erythematosus, and rheumatoid arthritis.

  • March 19, 2020 - Roche announced they working with the US FDA to initiate a Phase III clinical trial in collaboration with BARDA, a part of the US Health HHS, to evaluate the safety and efficacy of Actemra®/RoActemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

  • March 17, 2020 - Regeneron Pharmaceuticals announced scientists have now isolated hundreds of virus-neutralizing, fully-human antibodies from the company's VelocImmune® mice, which have been genetically-modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19, in order to maximize the pool of potentially potent antibodies. From this large pool of candidates, Regeneron will select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities. 

  • March 16, 2020 - Regeneron Pharmaceuticals, Inc. and Sanofi announced they have started a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 infection. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody.

  • March 13, 2020 - Enanta Pharmaceuticals, Inc. announced that it has initiated a program to discover direct-acting antiviral drug candidates for the treatment of patients infected with the novel coronavirus SARS-CoV-2, which causes COVID-19 disease in humans.

  • March 10, 2020 - An article published in The Guardian said 'the USA, China, and Italy are already using Remdesivir on a compassionate basis to treat small numbers of patients with severe Covid-19 disease.'
  • March 9, 2020 - The Bill & Melinda Gates Foundation, Wellcome, and Mastercard announced the intent to provide seed-funding up to $125 million to speed-up the response to the COVID-19 disease epidemic by launching the COVID-19 Therapeutics Accelerator.
  • March 6, 2020 - Innovation Pharmaceuticals announced a 2nd Material Transfer Agreement to provide Brilacidin to a major U.S. university for analysis. Brilacidin is one of the few drugs targeting COVID-19 disease that has been tested in human trials for other clinical indications, providing an established safety and efficacy profile, developed both as an intravenous medicine and as a possible vaccine.
  • March 5, 2020 - A study published in Cell by German researchers who identified a cellular protein that is important for the entry of the SARS-CoV-2 virus into lung cells. "Our results show that SARS-CoV-2 requires the protease TMPRSS2, which is present in the human body, to enter cells," says Stefan Pöhlmann, head of the Infection Biology Unit at the German Primate Center. "This protease is a potential target for therapeutic intervention."
  • March 4, 2020 - Takeda Pharmaceutical announced that it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals infected with COVID-19 disease, while also studying whether Takeda’s currently marketed and pipeline products may be effective treatments for infected patients.
  • March 3, 2020 - Regeneron CEO Leonard Schleifer told CNBC that the pharmaceutical company hopes to have its coronavirus treatment produced and ready for human testing possibly by August 2020. Understanding the urgency with which the coronavirus needs to be confronted, Schleifer said Regeneron will be pursuing clinical trials and drug manufacturing at once
  • March 2, 2020 - Innovation Pharmaceuticals offers a scientific rationale and clinical development perspective for Brilacidin, the Company’s defensin mimetic drug candidate, as a potential novel coronavirus (COVID-19) treatment. Notably, Brilacidin is one of the few drugs targeting COVID-19 that has been tested in humans in Phase 2 clinical trials for other clinical indications, providing an established safety and efficacy profile, thereby potentially enabling it to rapidly help confront the emerging worldwide coronavirus crisis.
  • March 02, 2020 - Mateon Therapeutics, Inc. announced a new division will be dedicated to the development of rapid responses to the current COVID-19 virus outbreak, as well as future virus outbreaks, and will be led by Dr. Cyril Empig, who has been appointed Head of the Rapid Antiviral Response Program.  

February COVID-19 Disease Treatment News

  • February 27, 2020 - Innovation Pharmaceuticals announced the signing of a Material Transfer Agreement with one of the country’s 12 Regional Biocontainment Labs (RBL) to research it's lead defensin mimetic drug candidate, Brilacidin, as a potential novel coronavirus treatment. Mechanism of action studies of Brilacidin, along with assessing possible synergistic effects with other antivirals, are also planned. It is anticipated these tests might be completed within several weeks of the RBL’s receipt of Brilacidin.

  • February 26, 2020 - Gilead Sciences, Inc. announced the initiation of Phase 3 clinical studies to evaluate the safety and efficacy of Remdesivir in adults, who are diagnosed with COVID-19 disease, which is caused by the SARS-CoV-2 coronavirus. The initiation of these human clinical studies follows the U.S. Food and Drug Administration’s rapid review and acceptance of Gilead’s investigational new drug filing for Remdesivir for the treatment of COVID-19 patients. Remdesivir is not yet licensed or approved anywhere and has not been demonstrated to be safe or effective for any use.

  • February 25, 2020 - Vir Biotechnology, Inc. and WuXi Biologics announced a development and manufacturing collaboration to advance and produce human monoclonal antibodies for the potential treatment of COVID-19, a disease caused by the SARS-CoV-2 coronavirus. Vir has identified a number of monoclonal antibodies that bind to SARS-CoV-2 and is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

  • February 25, 2020 - A phase 2 clinical trial of Gilead’s experimental drug remdesivir for the novel coronavirus, according to a posting on a government clinical trials database. The trial will be run by the University of Nebraska Medical Center along with the National Institute of Allergy and Infectious Diseases and will be conducted at up to 50 sites globally.

  • February 24, 2020 - Cocrystal Pharma, Inc. Announced License Agreement with Kansas State University Research Foundation for Norovirus and Coronavirus Antiviral Compounds. Cocrystal intends to pursue research and development of these antiviral compounds, including preclinical and clinical development. This license advances the Company's antiviral programs significantly by providing potent compounds for further development.

  • February 23, 2020 - Japan's health minister Katsunobu Kato said the anti-influenza medication Avigan will be used for COVID-19 treatment, as part of an observational study.

  • February 20, 2020 - Beroni Group announced its collaboration with Tianjin University in China to develop a medical solution for the coronavirus (COVID-19) epidemic. A team of scientists from Tianjin University and from Beroni Group is now working to develop a rapid detection method and precision-driven treatment of COVID-19 caused by SARS-CoV-2 infection using nanobody-based technology.

  • February 20, 2020 - WHO Director-General Tedros Adhanom Ghebreyesus said: "Preliminary results from two clinical trials testing potential treatments for the COVID-19 coronavirus are expected in 3 weeks. Even if people are infected, having better outcomes, saving their lives, is really key." One trial combines HIV drugs Lopinavir and Ritonavir, while the other is testing the antiviral Remdesivir.

  • February 18, 2020 - China's National Medical Products Administration has approved the marketing of Favilavir, formerly known as Fapilavir, an antiviral medication that has shown efficacy in treating the novel coronavirus COVID-19. Favilavir was developed by Zhejiang Hisun Pharmaceutical, which is the 1st drug that has been approved for marketing in China. Fapilavir is reported to have demonstrated efficacy with minor side effects in an ongoing 70-patient clinical trial in Shenzhen, Guangdong province.

  • February 17, 2020 - China developed the 5th version for trial implementation of the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia" based on the revisions of the previous version.

  • February 15, 2020, the CDC announced it had grown the COVID-19 virus in cell culture, which is necessary for further studies, including for additional genetic characterization. The cell-grown virus was sent to NIH’s BEI Resources Repositoryexternal icon for use by the broad scientific community.

  • February 13, 2020 - Gilead Sciences antiviral drug prevented disease and reduced the severity of symptoms in monkeys infected with Middle East Respiratory Syndrome (MERS), an infection closely related to the fast-spreading coronavirus that originated in China, reported a study published in the Proceedings of the National Academy of Sciences. The MERS study was supported in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

  • February 12, 2020 - Chinese pharma company BrightGene said it has successfully copied Gilead Science's Remdesivir in a Nasdaq-style China disclosure. The Suzhou-based BrightGene also said it has already mass-produced remdesivir's active ingredient and is in the process of turning it into finished doses.

  • February 7, 2020 - A study published in JAMA reported 'Antibacterial agents are ineffective.' All of the patients in this study received antibacterial agents, 90% received antiviral therapy, and 45% received methylprednisolone. The dose of oseltamivir and methylprednisolone varied depending on disease severity. However, no effective outcomes were observed.

  • February 4, 2020 - HHS and Regeneron Collaborate to Develop 2019-nCoV Treatment. BARDA and Regeneron now will leverage their partnership agreement to develop multiple monoclonal antibodies that, individually or in combination, could be used to treat this emerging coronavirus, also known as 2019-nCoV. These monoclonal antibodies are produced by a single clone of cells or a cell line with identical antibody molecules. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells. Medicines developed for 2019-nCoV through the expanded BARDA-Regeneron partnership will leverage Regeneron's monoclonal antibody discovery platform called VelocImmune, part of the company's VelociSuite technology.

  • February 4, 2020 - A new study published in Nature reports '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.

  • February 4, 2020 - The Lancet - Baricitinib as a potential treatment for 2019-nCoV acute respiratory disease. 'Because the plasma concentration of baricitinib on therapeutic dosing (either as 2 mg or 4 mg once daily) is sufficient to inhibit AAK1, we suggest it could be trialed, using an appropriate patient population with 2019-nCoV acute respiratory disease, to reduce both the viral entry and the inflammation in patients, using endpoints such as the MuLBSTA score, an early warning model for predicting mortality in viral pneumonia.'

  • February 3, 2020 - Zhang Dingyu, president of Wuhan Jinyintan Hospital, said at the news conference 'that the hospital was the first to use lopinavir/ritonavir, which is sold under the brand name Kaletra and a medication for the treatment and prevention of HIV/AIDS, to treat patients with the novel coronavirus. "It seems that Kaletra is effective in patients with early symptoms. It can help prevent the disease from getting severe and life-threatening, but we still need stronger evidence," said Zhang. Zhang warned people that the side effects of Kaletra include gastrointestinal discomfort, allergy, and hepatic damage. Lopinavir/ritonavir is being investigated (Chinese clinical trial registry identifier: ChiCTR2000029308) based on previous studies suggesting possible clinical benefit in SARS and MERS. The research team of Li Lanjuan, one of China's leading scientists in the fight against the novel coronavirus, announced a major breakthrough on Tuesday, China's Changjiang daily reported. Preliminary tests showed that two drugs - Abidol and Darunavir – can effectively inhibit the virus in vitro cell experiments, according to Li, who is also a professor at Zhejiang University. 

  • February 3, 2020 - AntiCancer Inc. said “Oral recombinant methioninase has high potential to slow or arrest infection of 2019-nCoV in patients, with and without symptoms,” said Dr. Qinghong Han, methioninase project leader at AntiCancer. “We will first test methioninase in cultured lung cells infected with 2019-nCoV in vitro, and then test oral recombinant methioninase in patients infected with the virus. We will carry out these tests in China with the appropriate organizations and safety profiles. Oral recombinant methioninase should be an effective therapy for infections caused by the 2019-nCoV since coronaviruses have a special requirement for methionine,”

  • February 2, 2020 – California-based Gilead Sciences issued a statement announcing Washington State health officials used the unapproved antiviral drug Remdesivir to treat the 1st patient diagnosed with the novel coronavirus 2019-nCoV in the U.S.

January COVID-19 Disease Treatment News

  • January 31, 2020 — Gilead Sciences issued a statement from Merdad Parsey, M.D., Ph.D., Chief Medical Officer, Gilead Sciences: "Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir." Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.

  • January 27, 2020 - AbbVie’s fixed-dose HIV drug Kaletra—also known as Aluvia, is now recommended as a treatment for pneumonia caused by the new coronavirus known as 2019-nCoV, China’s National Health Commission says in its updated clinical guidance. Kaletra’s 2 antiretroviral components, lopinavir, and ritonavir are protease inhibitors designed to block HIV viral replication. One hypothesis holds that the drugs could do the same with 2019-nCoV, which is believed to have originated from the Chinese city of Wuhan. Although not approved to treat any coronavirus anywhere, it has shown efficacy in at least one case in the current outbreak in China.

  • Thailand doctors combined the anti-flu drug oseltamivir with lopinavir and ritonavir, antivirals used to treat HIV. The ministry was awaiting research results to prove the findings.

 

Note:  This content was last reviewed on March 22, 2020, by health care professionals, such as Dr. Robert Carlson.