By IDSE News Staff
The National Institutes of Health has initiated a multisite clinical trial evaluating an investigational antiviral for the treatment of COVID-19.
The therapeutic, known as ensitrelvir fumaric acid (S-217622), was discovered by Hokkaido University and Shionogi, both in Japan. The trial is assessing whether S-217622 can improve clinical outcomes for patients who are hospitalized for management of COVID-19 compared with placebo and plans to enroll approximately 1,500 people at sites worldwide. S-217622 is the first agent to be evaluated in a new global, adaptive clinical research protocol known as Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE).
The National Institute of Allergy and Infectious Diseases (NIAID) is funding the trial and working in partnership with the NIH’s National Center for Advancing Translational Sciences. Developed under the auspices of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public–private partnership, STRIVE may be adapted to rapidly assess multiple therapeutic interventions during outbreaks of respiratory diseases, such as COVID-19 or influenza.
“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, MD. “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.”
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.
S-217622 suppresses SARS-CoV-2 replication by inhibiting the function of a key virus protein known as 3CL protease. Participants will be assigned at random to receive S-217622 or placebo. Neither the investigators nor the participants will know who is receiving the investigational drug. S-217622 is taken by mouth once daily for five days. The first-day dose is three 125-mg tablets totaling 375 mg, followed by one 125-mg tablet per day for the next four days. All participants will receive the local standard of care for COVID-19, which may differ based on location, and could include another antiviral, as well as immunomodulatory drugs, corticosteroids and/or anticoagulants.
Investigators will monitor and record participants’ health status every day during the first week and then on prespecified days over a 60-day period. Participants also will be asked to provide blood samples and nose swabs for laboratory tests.
Participant safety will be monitored closely throughout the trial.
For more information about the trial, please visit ClinicalTrials.gov and search identifier NCT05605093.
