CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 367 enrolled
Drug / intervention
VIR-7831 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05780281
NCT05780281Phase 3Completed
CompareCT.gov

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H2: VIR-7831 (GSK4182136))

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 22, 2023·Updated Dec 27, 2023

In Brief

A Phase 3 clinical trial evaluating VIR-7831, Placebo, and 1 other intervention for COVID-19. Completed, enrolled 367 participants across 105 sites in 8 countries.

Detailed Summary

This study looks at the safety and effectiveness of VIR-7831 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either VIR-7831 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesDenmark, Poland, Singapore, Spain, Switzerland, Uganda, United Kingdom, United States
CollaboratorsInternational Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Vir Biotechnology, Inc., GlaxoSmithKline, University of Minnesota

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 22, 2023
Enrollment StartDec 16, 2020
Primary CompletionJun 9, 2021
Study CompletionOct 4, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.3 years ago

Interventions

VIR-7831biological

VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.

Placebobiological

Commercially available 0.9% sodium chloride solution

Remdesivirbiological

Antiviral agent