Status:
TERMINATED
Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
Lead Sponsor:
Vir Biotechnology, Inc.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Covid19
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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, ...
Eligibility Criteria
Inclusion
- Main Study participant must be aged 12 years or older AND at high risk of progression of COVID-19 or \> 55 years old
- Sub-Study participants must be aged 18 years or older at time of consent 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 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
- Known hypersensitivity to any constituent present in the investigational product
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
1065 Patients enrolled
Trial Details
Trial ID
NCT04913675
Start Date
June 10 2021
End Date
March 24 2023
Last Update
March 7 2024
Active Locations (50)
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1
Investigative Site
Anniston, Alabama, United States, 36207
2
Investigative Site
Mesa, Arizona, United States, 85210
3
Investigative Site
Tucson, Arizona, United States, 85712
4
Investigative Site
Los Angeles, California, United States, 90017