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

NCT04545060 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1057

Last updated 2022-11-07

Study results available
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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.

Conditions

  • Covid19

Interventions

BIOLOGICAL

VIR-7831 (sotrovimab)

VIR-7831 (sotrovimab) given by intravenous infusion (single dose)

DRUG

Placebo

Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2021-04-08
Completion
2021-09-02
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Brazil
  • Canada
  • Peru
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545060 on ClinicalTrials.gov