Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.

Stopped early · Phase 3

Conditions studied: Covid19

In brief

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, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.

Key facts

Study ID

NCT04913675

Run by

Vir Biotechnology, Inc.

People needed

1065

Starts

2021-06-10

Expected to finish

2023-03-24

Last updated by the study team

2024-03-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — Anniston, Alabama, United States
• Investigative Site — Mesa, Arizona, United States
• Investigative Site — Tucson, Arizona, United States
• Investigative Site — Los Angeles, California, United States
• Investigative Site — Rolling Hills Estates, California, United States
• Investigative Site — Bradenton, Florida, United States
• Investigative Site — Doral, Florida, United States
• Investigative Site — Doral, Florida, United States
• Investigative Site — Gainesville, Florida, United States
• Investigative Site — Hialeah, Florida, United States
• Investigative Site — Hialeah, Florida, United States
• Investigative Site — Hialeah, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — North Miami Beach, Florida, United States
• Investigative Site — Ormond Beach, Florida, United States
• Investigative Site — Palmetto Bay, Florida, United States
• Investigative Sites — Pembroke Pines, Florida, United States

Full record on ClinicalTrials.gov

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