U.S. NIH Evaluates New COVID-19 Antiviral for Adults

The U.S. government confirmed last week it had initiated a multi-site, late-stage clinical trial evaluating an investigational antiviral for the treatment of COVID-19.

The therapeutic candidate, known as S-217622 or ensitrelvir fumaric acid, was discovered by Hokkaido University, Sapporo, Japan, and Shionogi & Co., Ltd. 

S-217622 is the first agent to be evaluated in a global, adaptive clinical research protocol known as Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE), conducted by the U.S. National Institutes of Health.

“We hope results from this trial can be applied to improve the standard of care for people with COVID-19, which still causes hundreds of deaths each day in the United States, as well as to strengthen our pandemic preparedness,” said NIAID Deputy Director for Clinical Research and Special Projects H. Clifford Lane, M.D., in a media statement issued on February 15, 2023.

“The STRIVE protocol and clinical research infrastructure can be adapted to evaluate additional agents for COVID-19, as well as therapeutics for other respiratory pathogens.”

According to results shared by Shionogi from a Phase 3 clinical trial conducted in 2022, S-217622 reduced COVID-19 symptoms in people with mild-to-moderate COVID-19, regardless of risk factors or vaccination status,

Findings from the ACTIV-3 trials, which evaluated therapeutics for adults hospitalized with COVID-19, indicated that ongoing viral replication may play a role in driving disease progression to critical illness. The research team hypothesized that a significant number of patients hospitalized with COVID-19 may still benefit from antiviral therapy.

For more information about the trial, please visit clinicaltrials.gov and search identifier NCT05605093.

In the U.S., several COVID-19 antivirals are approved and available at most pharmacies.