HHS Funds Clinical Trial for Potential COVID-19 Treatment

March 24, 2020 - The Department of Health and Human Services (HHS) recently announced support for a Phase 2/3 clinical trial to evaluate a possible COVID-19 treatment for severely ill patients.

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The Biomedical Advanced Research and Development Authority (BARDA), within the Assistant Secretary for Preparedness and Response (ASPR), part of HHS, will support the clinical trial to uncover whether Kevzara is an effective COVID-19 treatment. 

FDA first approved Kevzara in 2017 for the treatment of adult patients with active rheumatoid arthritis. Kevzara was originally developed under collaboration between Regeneron and Sanofi, with Regerneron leading the US-based trials and Sanofi leading international trials. 

The partnership is among the first to be issued by BARDA with funding from the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 that the President Trump signed into law on March 6. 

Regeneron and Sanofi will continue to work together to study Kevzara’s effectiveness against COVID-19.

“We are working at a record pace with our private sector partners to speed development of therapeutic treatments for people with COVID-19,” said Rick A. Bright, PhD, BARDA director. “By repurposing a currently approved product, we may be able to expedite development and make treatments available quickly.”

Kevzara is a fully human monoclonal antibody that binds to the IL-6 receptor on normal cells. Experts believe the drug may improve patients with COVID-19 who are more susceptible to life-threatening respiratory failure by decreasing the 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,” HHS stated. 

The Phase 2/3 clinical trial will focus on the safety and effectiveness of Kevzara in decreasing the time that a person with COVID-19 remains ill. The first part of the trial will evaluate the effectiveness of the drug on fever and patients’ need for supplemental oxygen The second part of the trial will evaluate the improvement in longer-term outcomes, including whether the drug reduces mortality or the need for mechanical ventilation, supplemental oxygen, and hospitalization. 

Additionally, a current HHS-funded trial evaluates the safety and efficacy of antiviral drug remdesivir in hospitalized adults with COVID-19.

At the end of February 2020, the National Institute of Allergy and Infectious Diseases (NIAID) sponsored the first controlled clinical trial in the US at the University of Nebraska Medical Center (UNMC) to evaluate remdesivir.

“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said NIAID director and US Coronavirus Task Force member Anthony S. Fauci, MD. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.” 

The first US trial participant was an American who volunteered after being quarantined on the cruise ship that docked in Yokohama, Japan in early February. Researchers expect to eventually enroll participants at other sites and the US worldwide.

The study gave potential participants a baseline exam and then randomly assigned individuals to either the remdesivir or placebo group. An independent data and safety monitoring board (DSMD) will continue to monitor ongoing results to ensure patient safety and provide updates as necessary. 

“Proven treatment options for COVID-19 are urgently needed. This trial of Kevzara is critical to inform doctors on treatment options for COVID-19,” HHS Secretary Alex Azar said. “The close collaboration between BARDA, FDA, and Regeneron to initiate this trial as soon as possible again demonstrates the speed at which we are responding to this pandemic.” 

BARDA stressed that they will continue to seek partners for COVID-19 medical countermeasures. They currently offer various ways to submit proposals for potential new products or technologies.