Coronavirus vaccine trial administers first doses to participants
A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine on 03/16/20. Read more
FDA to allow COVID-19 test kits to bypass the agency’s approval process
The Food and Drug Administration announced that it will allow private companies to begin marketing coronavirus test kits directly to the public, in a new initiative to ease a chronic shortage of test kits. The FDA said it will review the accuracy of test data submitted by the manufacturers retroactively—a decision that FDA Commissioner Stephen Hahn acknowledged had risks, but was warranted by the severity of the pandemic. Read more
New rapid COVID-19 test produces fast results
Scientists at the University of Oxford have developed a new coronavirus test that produces results around three times faster than the current fastest testing methods, and that requires only relatively simple technical instrumentation. In addition to these benefits, the researchers behind the test’s development say that it could even help detect patients affected by coronavirus in earlier stages of infection versus current methods, and that its results can be “read by the naked eye,” which makes it more accessible to a broader range of healthcare facilities and professionals. Read more
Multiple therapeutic investigated for the treatment of COVID-19 infection
Based on results of clinical trials conducted with affected patients in both Wuhan and Shenzhen by Chinese medical authorities, Japanese-made flu drug favipiravir (also known as Avigan) has been shown to be effective in both reducing the duration of the COVID-19 virus in patients and to have improved the lung conditions of those who received treatment with the drug. Read more
Remdesivir is a broad spectrum anti-viral drug developed by Gilead Sciences as a treatment for Ebola virus, which also showed success in treatment of monkeys infected with the Middle-Eastern Respiratory Syndrome (MERS), a different type of coronavirus. It is now being tested as a potential COVID-19 therapy in clinical trials lead by the National Institutes of Health. Read more
HIV Anti-Retroviral Agents
AbbVie, the manufacturer of HIV drugs Kaletra/Aluvia, is collaborating with health authorities to determine the efficacy of using its HIV drugs to treat COVID-19. The company is working with the FDA, CDC, and European agencies to begin clinical trials of the drug. Read more
Sanofi is assessing the risk and benefit of its malaria drug hydroxychloroquine for the management of coronavirus. According to the company, some health authorities are allowing the temporary use of chloroquine for the management of COVID-19, but there is insufficient data to draw any conclusions over its efficacy. Any use of the drug in this context is considered “off-label” use.
Based on encouraging preliminary findings from a study in France, Sanofi is looking at ways to collaborate and partner with health authorities investigating the use of hydroxychloroquine for the management of coronavirus. Read more here and here
Chinese researchers have used an anti-inflammatory drug to curb the effects of the coronavirus on critical patients, and now the maker of the drug says it is talking to the Food and Drug Administration about clinical trials.
Tocilizumab, sold under the name Actemra, made by the Swiss pharmaceutical firm Roche, is a prescription medicine used to treat adults with moderate to severe active rheumatoid arthritis, as well as certain types of juvenile arthritis.
Chinese physicians have used Tocilizumab to prevent an overreaction of the immune system that has led to organ failure and death in coronavirus patients. An initial clinical trial in China used Actemra in 20 severe COVID-19 cases. The drug has now been approved for use in China, but has not yet been approved in the United States. Read more
Roche is not alone in looking into rheumatoid arthritis drugs as a potential treatment. Sanofi and Regeneron are launching a clinical trial in New York to see if their rheumatoid arthritis drug Kevzara is effective. Read more
Neutralizing human antibody therapy
AbCellera and Eli Lilly and Company have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
Within one week of receiving a blood sample from one of the first U.S. patients who recovered from COVID-19, AbCellera screened over 5 million immune cells looking for ones that produced functional antibodies that helped the patient neutralize the virus and recover from the disease. From this effort, AbCellera has identified over 500 unique fully human antibody sequences, the largest panel of anti-SARS-CoV-2 antibodies ever reported. The next step is to screen these antibodies to find the ones most effective in neutralizing SARS-CoV-2. Many of these antibodies will be expressed in collaboration with partners at the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and pending agreement with NIAID will be tested for their ability to neutralize the virus. Read more
SELECTED REPURPOSED DRUGS IN CLINICAL DEVELOPMENT TO TREAT COVID-19
|Drug or cocktail||Originator company||Status and mechanisms||Clinical trials (trial posting date)|
|ASC09/ritonavir, lopinavir/ritonavir, with or without umifenovir||Ascletis, AbbVie, Pharmstandard||ASC09 is an experimental HIV-1 protease inhibitor; ritonavir and lopinavir/ritonavir are approved protease inhibitors for HIV/AIDS; umifenovir is an approved entry inhibitor against influenza||At least three trials (e.g., ChiCTR2000029603, 2/6/20)|
|ASC09/oseltamivir, ritonavir/oseltamivir, oseltamivir||Ascletis, Gilead, AbbVie||See above; oseltamivir is a sialidase inhibitor approved for influenza||One trial (NCT04261270, 2/7/20)|
|Azvudine||Zhengzhou Granlen PharmaTech||Experimental reverse transcriptase inhibitor drug against HIV-1/AIDS||One trial (ChiCTR2000029853, 2/15/20)|
|Various combinations of baloxavir marboxil/favipiravir and lopinavir/ritonavir||Shionogi, Toyama Chemical||Baloxavir marboxil is a Cap-dependent endonuclease inhibitor and favipiravir is a guanine analog RNA-dependent RNA polymerase inhibitor approved for influenza A and B; see above||Two trials (ChiCTR2000029544, 2/3/20; ChiCTR2000029548, 2/4/20)|
|Various combinations of darunavir/cobicistat alone or with lopinavir/ritonavir and thymosin α1||Janssen, Gilead||Darunavir and cobicistat are, respectively, an HIV-1 protease inhibitor and inhibitor of cytochrome P450 (CYP)3A enzyme, approved as a combination against HIV-1/AIDS. Thymosin α1 is an immune response boosting agent||Two trials (NCT04252274, 2/5/20; ChiCTR2000029541, 2/3/20)|
|Remdesivir||Gilead||Phosphoramidate prodrug of an adenine analog used for Ebola and Marburg virus outbreaks (similar structure to approved HIV reverse transcriptase inhibitors)||Two trials (NCT04252664, 2/5/20; NCT04257656, 2/6/20)|
|Chloroquine or hydroxychloroquine||Shanghai Zhongxi Pharmaceutical, Shanghai Ziyuan Pharmaceutical, Wuhan Wuyao Pharmaceutical||Endosomal acidification fusion inhibitor||At least ten trials (e.g., ChiCTR2000029826, 2/2/20; NCT04261517, 2/14/20)|
|Methylprednisolone||Generic||Synthetic corticosteroid that binds to nuclear receptors to dampen proinflammatory cytokines||One trial (NCT04263402, 2/10/20)|
|Interferon alfa-2b alone or in combination with lopinavir/ritonavir and ribavirin||Biogen, Merck||Interferon alfa-2b is a recombinant cytokine with antiviral properties; ribavirin is a guanine derivative; as above||Two trials (NCT04254874, 2/5/20; ChiCTR2000029308, 1/23/20)|
|Camrelizumab and thymosin||Incyte, Shanghai Hengrui Pharmaceutical||Camrelizumab is a humanized monoclonal antibody (mAb) targeting PD-1||Two trials (ChiCTR2000029806, 2/14/20; NCT04268537, 2/14/20)|
|Tocilizumab||Chugai Pharmaceutical, Zhejiang Hisun Pharmaceutical, Jiangsu Qyun Bio-Pharmaceutical||Humanized mAb targeting interleukin-6||One trial (ChiCTR2000029765, 2/13/20)|