Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd.
The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35233, United States
Palo Alto, California 94304, United States
San Francisco, California 94110, United States
Torrance, California 90502, United States
Washington D.C., District of Columbia 20010, United States
Washington D.C., District of Columbia 20422, United States
Minneapolis, Minnesota 55455, United States
Hershey, Pennsylvania 17033, United States
Charlottesville, Virginia 22908, United States
Liverpool, New South Wales 2170, Australia
Caxias do Sul, Rio Grande do Sul 95070-561, Brazil
Criciúma, Santa Catarina 88801-000, Brazil
Joinville, Santa Catarina 89204-061, Brazil
Marília, São Paulo 17525-160, Brazil
São Paulo, São Paulo 01323-001, Brazil
São Paulo, São Paulo 05652-900, Brazil
Hvidovre, 2650, Denmark
Bonn, 53127, Germany
Athens, Attica 10676, Greece
Athens, Attica 11527, Greece
Shinjuku-Ku, Tokyo 162-8655, Japan
Mexico City, Mexico City 14080, Mexico
Mexico City, Mexico City 14080, Mexico
Cape Town, Western Cape 7925, South Africa
Seongnam-si, Gyeonggi-do 13620, South Korea
Ivano-Frankivsk, 76018, Ukraine