NIH trial to evaluate Shionogi antiviral 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, 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 one of the first agents 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), part of NIH, is funding the trial and working in partnership with NIH’s National Center for Advancing Translational Sciences (NCATS). 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.
