VIR-7831 for the Early Treatment of COVID-19 in Outpatients

Purpose

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.

Condition

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VIR-7831 (Sotrovimab) 		Participants received 500 mg sotrovimab administered intravenously (IV)
  • Biological: VIR-7831 (sotrovimab)
    VIR-7831 (sotrovimab) given by intravenous infusion (single dose)
Placebo Comparator
Placebo 		Participants received placebo administered intravenously (IV)
  • Drug: Placebo
    Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)

Recruiting Locations

More Details

NCT ID
NCT04545060
Status
Completed
Sponsor
Vir Biotechnology, Inc.