Trials / Terminated
TerminatedNCT04913675
Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,065 (actual)
- Sponsor
- Vir Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | sotrovimab | Sotrovimab 500 mg given by intravenous infusion over 15 min |
| BIOLOGICAL | sotrovimab | Sotrovimab 500 mg given by intramuscular injection |
| BIOLOGICAL | sotrovimab | Sotrovimab 250 mg given by intramuscular injection |
| BIOLOGICAL | sotrovimab | Sotrovimab 2000 mg given by intravenous infusion over 60 min |
| BIOLOGICAL | Sotrovimab | Sotrovimab 2000 mg given by intravenous infusion over 30 min |
| BIOLOGICAL | Sotrovimab | Sotrovimab 2000 mg given by intravenous infusion over 15 min |
| BIOLOGICAL | Sotrovimab | Sotrovimab up to 3000 mg given by intravenous infusion over 90 min |
Timeline
- Start date
- 2021-06-10
- Primary completion
- 2022-07-19
- Completion
- 2023-03-24
- First posted
- 2021-06-04
- Last updated
- 2024-03-07
- Results posted
- 2023-05-26
Locations
50 sites across 3 countries: United States, France, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04913675. Inclusion in this directory is not an endorsement.