The National Institutes of Health in US has initiated a Phase 3 Trial for Ensitrelvir Fumaric Acid in Adults Hospitalized with COVID-19
The National Institutes of Health has initiated a multi-site clinical trial evaluating an investigational antiviral for the treatment of COVID-19. The therapeutic, known as S-217622 or ensitrelvir fumaric acid (3CL protease inhibitor), was discovered by Hokkaido University, Sapporo, Japan; and Shionogi & Co., Ltd., Osaka, Japan.
The trial is assessing whether S-217622 can improve clinical outcomes for patients who are hospitalized for management of COVID-19 as compared to a placebo and will 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).
Participants will be assigned at random to receive S-217622 or a 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 milligram (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.
S-217622 suppresses SARS-CoV-2 replication by inhibiting the function of a key virus protein known as 3CL protease. The antiviral reduced COVID-19 symptoms in people with mild-to-moderate COVID-19, regardless of risk factors or vaccination status, according to results shared by Shionogi from a Phase 3 clinical trial conducted mainly in Japan.
In November 2022, the drug received emergency regulatory approval in Japan, where it is referred to by the brand name Xocova. The ongoing ACTIV-2 SCORPIO-HR clinical trial, also funded by NIAID, is evaluating the antiviral in the outpatient population.