BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Phase 3 Completed 353 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collab Brii Biosciences Limited · collab Cardiothoracic Surgical Trials Network · collab International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) · collab Kirby Institute · collab Medical Research Council · collab National Heart, Lung, and Blood Institute (NHLBI) · collab Prevention and Early Treatment of Acute Lung Injury · collab US Department of Veterans Affairs · collab University of Copenhagen · collab University of Minnesota · collab Washington D.C. Veterans Affairs Medical Center · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2020-12-16
Primary completion: 2021-06-08
Completion: 2022-10-10

Outcome

Missed primary endpoint

paper Neither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19. PMID 34953520 ↗

Publications

Results ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial. Lancet Infect Dis. 2022 May;22(5):622-635. doi: 10.1016/S1473-3099(21)00751-9. Epub 2021 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMUBARVIMAB	Monoclonal antibody	1000 mg	Intravenous
Subject	ROMLUSEVIMAB	Monoclonal antibody	1000 mg	Intravenous
Background	Remdesivir	Small molecule	—	Intravenous