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NCT05605093 · ClinicalTrials.gov registry record · Phase 3
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
A Phase 3 study, sponsored by University of Minnesota.
- Terminated
- Registry status
- Phase 3
- Development phase
- 602
- Enrollment target
NCT05605093: Clinical Trial Phase 3 study, sponsored by University of Minnesota.
NCT05605093 is a Phase 3 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 602 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05605093, a Phase 3 study, was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 602 participants
- Enrollment target
Study 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.
Primary Outcome
DRS-60 is a version of the STRIVE clinical recovery scale (CRS) which combines time to recovery with non-recovered clinical state and death to an ordinal outcome.0 indicates best results, 60 represents recovered on Day 60, with not recovered by Day 60 coded as 61 and death (worst outcome) as 62.
Interventions
- DRUG placebo
- DRUG Shionogi Protease Inhibitor (S-217622)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2022-12-23 |
| Est. Completion | 2025-10-28 |
| Phase | Phase 3 |
Why NCT05605093 stopped before completion
NCT05605093 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05605093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05605093 about?
NCT05605093 is a clinical study titled "Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)". 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) develop...
What is the current status of trial NCT05605093?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 602 participants. The study started on 2022-12-23. Estimated completion is 2025-10-28.
What interventions are being tested in trial NCT05605093?
The interventions under investigation include: placebo (DRUG), Shionogi Protease Inhibitor (S-217622) (DRUG).
Who is sponsoring clinical trial NCT05605093?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05605093's enrollment target sits among peer trials
602 607th of 2000 higher than 1,393 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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