Trials / Completed
CompletedNCT04545060
VIR-7831 for the Early Treatment of COVID-19 in Outpatients
A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,057 (actual)
- Sponsor
- Vir Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VIR-7831 (sotrovimab) | VIR-7831 (sotrovimab) given by intravenous infusion (single dose) |
| DRUG | Placebo | Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose) |
Timeline
- Start date
- 2020-08-27
- Primary completion
- 2021-04-08
- Completion
- 2021-09-02
- First posted
- 2020-09-10
- Last updated
- 2022-11-07
- Results posted
- 2022-11-07
Locations
91 sites across 7 countries: United States, Austria, Brazil, Canada, Peru, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04545060. Inclusion in this directory is not an endorsement.