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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 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 - Known hypersensitivity to any constituent present in the investigational product

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Main Study - Sotrovimab 500 mg IV
  • Biological: sotrovimab
    Sotrovimab 500 mg given by intravenous infusion over 15 min
Experimental
Main Study - Sotrovimab 500 mg IM
  • Biological: sotrovimab
    Sotrovimab 500 mg given by intramuscular injection
Experimental
Main Study - Sotrovimab 250 mg IM
  • Biological: sotrovimab
    Sotrovimab 250 mg given by intramuscular injection
Experimental
Substudy (Cohort A) - Sotrovimab 2000 mg IV
  • Biological: sotrovimab
    Sotrovimab 2000 mg given by intravenous infusion over 60 min
Experimental
Substudy (Optional Cohort B1) - Sotrovimab 2000 mg IV
  • Biological: Sotrovimab
    Sotrovimab 2000 mg given by intravenous infusion over 30 min
Experimental
Substudy (Optional Cohort B2) - Sotrovimab 2000 mg IV
  • Biological: Sotrovimab
    Sotrovimab 2000 mg given by intravenous infusion over 15 min
Experimental
Substudy (Optional Cohort C) - Sotrovimab up to 3000 mg IV
  • Biological: Sotrovimab
    Sotrovimab up to 3000 mg given by intravenous infusion over 90 min

Recruiting Locations

More Details

NCT ID
NCT04913675
Status
Terminated
Sponsor
Vir Biotechnology, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.