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

IF 4.6 2区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

iScience Pub Date : 2025-02-04 DOI:10.1016/j.isci.2025.111938

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 , for the ACTIV-2/A5401 Study Team

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引用次数: 0

Abstract

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.

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来源期刊

iScience Multidisciplinary-Multidisciplinary

CiteScore

7.20

自引率

1.70%

发文量

1972

审稿时长

6 weeks

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