NCT05605093

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Shionogi Protease Inhibitor (S-217622)	S-217622 (ensitrelvir) is an oral anti-SARS-CoV2 PI that does not require ritonavir co-administration The dose is 375/125 (375 mg on Day 0, followed by 125 mg daily on Days 1-4).
DRUG	placebo	Placebo is an oral tablet administered once (3 tabs) on Day 0 and once (1 tab) daily on days 1-4, 5-day course.

Timeline

• Start date: 2022-12-23
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2022-11-04
• Last updated: 2025-11-17

Locations

187 sites across 24 countries: United States, Argentina, Australia, Brazil, Denmark, Georgia, Germany, Greece, Japan, Mexico, Nigeria, Peru, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Uganda, Ukraine, United Kingdom, Zimbabwe

Regulatory

• FDA-regulated drug study