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

  • STATUS
    Recruiting
  • End date
    Nov 29, 2022
  • participants needed
    1020
  • sponsor
    Vir Biotechnology, Inc.
Updated on 19 August 2021
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Summary

A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients

Details
Condition COVID19
Treatment VIR-7831
Clinical Study IdentifierNCT04913675
SponsorVir Biotechnology, Inc.
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be aged 12 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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