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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 is a Phase 3 study that was terminated before completion, run by Vir Biotechnology. The registered enrollment target is 1,065 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04913675
The ClinicalTrials.gov registry entry for NCT04913675 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,065 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vir Biotechnology, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which sotrovimab is the first listed.
NCT04913675 reports 0 study locations.
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.
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