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NCT04913675 · ClinicalTrials.gov registry record · Phase 3
Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
A Phase 3 study, sponsored by Vir Biotechnology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,065
- Enrollment target
NCT04913675: Clinical Trial Phase 3 study, sponsored by Vir Biotechnology.
NCT04913675 is a Phase 3 study that was terminated before completion, run by Vir Biotechnology. The registered enrollment target is 1,065 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04913675, a Phase 3 study, was terminated before completion, sponsored by Vir Biotechnology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,065 participants
- Enrollment target
Study Summary
The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
Primary Outcome
Progression of COVID-19 through Day 29 as defined by hospitalization \>24 hours for acute management of illness due to any cause or death. Percentage values are rounded off.
Interventions
- BIOLOGICAL sotrovimab
- BIOLOGICAL Sotrovimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,065 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2023-03-24 |
| Phase | Phase 3 |
Why NCT04913675 stopped before completion
NCT04913675 is an interventional study that assigns participants to a tested intervention. Its 1,065 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 2 interventions - of which sotrovimab is the first listed.
NCT04913675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04913675 about?
NCT04913675 is a clinical study titled "Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.". The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose lev...
What is the current status of trial NCT04913675?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,065 participants. The study started on 2021-06-10. Estimated completion is 2023-03-24.
What interventions are being tested in trial NCT04913675?
The interventions under investigation include: sotrovimab (BIOLOGICAL), Sotrovimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04913675?
This trial is sponsored by Vir Biotechnology, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04913675's enrollment target sits among peer trials
1,065 274th of 2000 higher than 1,727 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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