HHS funds clinical trial for potential COVID-19 treatment

Press release

An antibody medicine being evaluated to treat severe cases of novel coronavirus 2019 will receive additional support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response under an existing partnership with Regeneron Pharmaceuticals of Tarrytown, New York.

The Biomedical Advanced Research and Development Authority 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 novel coronavirus 2019 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 Donald 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.