Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Lead Sponsor:
Vir Biotechnology, Inc.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Covid19
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
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 asses...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT04779879
Start Date
February 18 2021
End Date
April 6 2022
Last Update
May 3 2023
Active Locations (31)
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1
Investigative Site
Anniston, Alabama, United States, 36207
2
Investigative Site
Bakersfield, California, United States, 93301
3
Investigative Site
Northridge, California, United States, 91325
4
Investigative Site
Ft. Pierce, Florida, United States, 34982