CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 353 enrolled
Drug / intervention
BRII-196 +3 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/NCT05780424
NCT05780424Phase 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 H3: BRII-196/BRII-198)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 22, 2023·Updated Feb 5, 2024

In Brief

A Phase 3 clinical trial evaluating BRII-196, BRII-198, and 2 other interventions for COVID-19. Completed, enrolled 353 participants across 107 sites in 8 countries.

Detailed Summary

This study looks at the safety and effectiveness of BRII-196/BRII-198 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either BRII-196/BRII-198 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H3.

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, Brii Biosciences Limited, University of Minnesota

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 22, 2023
Enrollment StartDec 16, 2020
Primary CompletionJun 8, 2021
Study CompletionOct 10, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.3 years ago

Interventions

BRII-196biological

BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.

BRII-198biological

BRII-198 is a fully human IgG-1 mAb derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.

Placebobiological

Commercially available 0.9% sodium chloride solution

Remdesivirbiological

Antiviral agent