VIR-7831 for the Early Treatment of COVID-19 in Outpatients
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old - Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms
Exclusion Criteria
- Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours - Symptoms consistent with severe COVID-19 - Participants who, in the judgement of the investigator are likely to die in the next 7 days - Severely immunocompromised participants
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VIR-7831 (Sotrovimab) |
Participants received 500 mg sotrovimab administered intravenously (IV) |
|
|
Placebo Comparator Placebo |
Participants received placebo administered intravenously (IV) |
|
Recruiting Locations
More Details
- NCT ID
- NCT04545060
- Status
- Completed
- Sponsor
- Vir Biotechnology, Inc.