Safety Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    340
  • sponsor
    Vir Biotechnology, Inc.
Updated on 30 July 2021

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 assessed for safety, tolerability, and pharmacokinetics.

Details
Condition COVID19
Treatment VIR-7831 (Gen1), VIR-7831 (Gen2), Sotrovimab (Gen1), Sotrovimab (Gen2)
Clinical Study IdentifierNCT04779879
SponsorVir Biotechnology, Inc.
Last Modified on30 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For Part A, participants must be aged 18 years or older 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
For Parts B and C, participants must be aged between 18 years and 69 years old at the time of obtaining informed consent

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
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)
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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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