Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

Keywords

COVID-19, Respiratory Tract Infections, HIV Protease Inhibitors, Protease Inhibitors, Shionogi Protease Inhibitor (S-217622)

Eligibility

Locations

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Minnesota
ID
NCT05605093
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1500 study participants
Last Updated