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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 is a Phase 3 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 602 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05605093
The ClinicalTrials.gov registry entry for NCT05605093 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05605093 reports 0 study locations.
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.
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