March 21, 2020
HHS Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19
An antibody medicine being evaluated to treat severe cases of coronavirus disease 2019 (COVID-19) will receive additional support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) under an existing partnership with Regeneron Pharmaceuticals of Tarrytown, New York.
The Biomedical Advanced Research and Development Authority (BARDA) within ASPR will provide support for a U.S. Phase 2/3 clinical trial to evaluate Kevzara as a potential treatment for severely ill COVID-19 patients. Currently, Kevzara is approved by the U.S. Food and Drug Administration for the treatment of rheumatoid arthritis. Kevzara was developed under a collaboration between Regeneron and Sanofi; the companies continue to collaborate on studying Kevzara for COVID-19, with Regeneron leading U.S.-based trials and Sanofi leading trials outside the U.S.
“We are working at a record pace with our private sector partners to speed development of therapeutic treatments for people with COVID-19,” said BARDA Director Rick A. Bright, PhD. “By repurposing a currently approved product, we may be able to expedite development and make treatments available quickly.”
Patients with COVID-19 are at risk of developing life-threatening respiratory failure, which may be mediated in part by elevated levels of a series of pro-inflammatory molecules, including interleukin-6 (IL-6). Kevzara is a fully-human monoclonal antibody that binds to the IL-6 receptor on normal cells and may improve patient outcomes by decreasing the severe inflammatory response.
The role of IL-6 is supported by preliminary uncontrolled data from a Chinese trial of a different IL-6 agent, which showed rapid reductions in fever in all patients and improvements in oxygenation. The Phase 2/3 clinical trial will determine if Kevzara can be used as a safe and effective therapy to reduce the amount of time that a person infected with the novel coronavirus remains ill. The first part of the trial will evaluate the impact of Kevzara on fever and patients' need for supplemental oxygen. The second, larger part of the trial will evaluate the improvement in longer-term outcomes, including whether it can prevent death and reduce the need for mechanical ventilation, supplemental oxygen, and/or hospitalization.
This partnership with Regeneron is among the first to be issued by BARDA with funding from the H.R.6074 – Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 that was passed by the U.S. Congress and signed by President Trump on March 6, 2020.
HHS continues to work across the U.S. government, including with the Department of Defense, to review potential products from public and private sectors to identify promising candidates that could detect, protect against, or treat COVID-19 for development and FDA approval/clearance.
In addition to this adaptive Phase 2/3 clinical trial with Kevzara, one other HHS-funded trial of an investigational COVID-19 treatment is ongoing. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is sponsoring a randomized controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults.
“Proven treatment options for COVID-19 are urgently needed. This trial of Kevzara is critical to inform doctors on treatment options for COVID-19,” said HHS Secretary Alex Azar. “The close collaboration between BARDA, the FDA, and Regeneron to initiate this trial as soon as possible again demonstrates the speed at which we are responding to this pandemic.”
HHS divisions, including NIH and ASPR, are supporting the development of multiple diagnostic tests, vaccines, and potential therapeutic treatments for COVID-19. BARDA continues to seek partners for COVID-19 medical countermeasures, and offers multiple ways to submit proposals for potential new products or technologies.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.