Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Purpose
This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
Condition
- Covid19
Eligibility
- Eligible Ages
- Between 18 Years and 69 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- For Part A, participants must be aged 18 years or older at the time of obtaining informed consent - For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent - Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 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 - For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing) - For Parts B and C, conditions that would prohibit receipt of IM injections in the investigator's opinion - For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for 90 days after dosing)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Part A is double-blinded. Parts B and C are open label.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Sotrovimab (Gen1) |
Part A (double-blinded) participants will be randomized to receive 500 mg of an IV infusion of Sotrovimab Gen 1 material or 500 mg of an IV infusion of VIR-7831 Gen 2 material |
|
Active Comparator Sotrovimab (Gen2) |
Part B (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or by IM injection Part C (open-label) participants will be randomized to receive 500 mg of Sotrovimab Gen2 material by IV infusion or 250 mg by IM injection |
|
Recruiting Locations
More Details
- NCT ID
- NCT04779879
- Status
- Completed
- Sponsor
- Vir Biotechnology, Inc.