Tixagevimab/cilgavimab or placebo for COVID-19 in ACTIV-2: Safety, pharmacokinetics and neutralizing and anti-drug antibodies

Tixagevimab/cilgavimab or placebo for COVID-19 in ACTIV-2: Safety, pharmacokinetics and neutralizing and anti-drug antibodies

Summary: Monoclonal antibodies have potential as rapidly developable agents for treatment and prevention of emerging viruses. The ACTIV-2 trial randomized persons with mild-moderate COVID-19 to the monoclonal antibody combination tixagevimab/cilgavimab via intramuscular injection (600 mg IM) or infu...

Full description

Saved in:
Bibliographic Details
Main Authors: Rachel A. Bender Ignacio, Kara W. Chew, Carlee Moser, Judith S. Currier, Joseph J. Eron, Arzhang Cyrus Javan, Mark J. Giganti, Justin Ritz, Michael Gibbs, Hervé Tchouakam Kouekam, Mark T. Esser, Eric S. Daar, Manish Choudhary, Rinki Deo, Courtney V. Fletcher, Jonathan Z. Li, Michael D. Hughes, Davey Smith, David Alain Wohl
Format: Article
Language:English
Published: Elsevier 2025-03-01
Series:iScience
Subjects:
Health sciences
Medicine
Medical specialty
Immunology
Online Access:http://www.sciencedirect.com/science/article/pii/S2589004225001981
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Summary: Monoclonal antibodies have potential as rapidly developable agents for treatment and prevention of emerging viruses. The ACTIV-2 trial randomized persons with mild-moderate COVID-19 to the monoclonal antibody combination tixagevimab/cilgavimab via intramuscular injection (600 mg IM) or infusion (300 mg IV) versus placebo. We present final safety and laboratory outcomes; primary outcomes were previously reported. The analyzed IM group included 214 participants, and the IV group, 106 participants. Adverse events were not different between treatment and placebo. The half-life of both components was >90 days for IM or 75 days for IV. New anti-drug antibodies were about 3 times more likely in active vs. placebo recipients. SARS-CoV-2 neutralizing antibodies increased 157-fold at 7 days and 127-fold at 1 month (IM-treated) but were less robust in IV participants. These data can inform future development of monoclonal antibodies against SARS-CoV-2 and other viruses, even if this intervention is of low utility for contemporary SARS-CoV-2 variants.
ISSN:2589-0042

Similar Items