Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion

Description

Summary

This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.

Official Title

A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients

Keywords

Covid19, SARS-CoV-2, coronavirus, coronavirus disease 2019, COVID-19, VIR-7831 (sotrovimab)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participant must be aged 18 years or older 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 5 days from onset of symptoms

You CAN'T join 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
  • Severely immunocompromised participants

Locations

  • Investigative Site
    Sacramento California 95817 United States
  • Investigative Site
    Oxnard California 93030 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Vir Biotechnology, Inc.
Links
Sign up for this study
ID
NCT04545060
Phase
Phase 2/3 COVID-19 Research Study
Study Type
Interventional
Participants
About 1057 people participating
Last Updated