Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19

作者：Myron J. Levin, Andrew Ustianowski, Stéphane De Wit, Odile Launay, Miles Avila, Alison Templeton, Yuan Yuan, Seth Seegobin, Adam Ellery, Dennis J. Levinson, Philip Ambery, Rosalinda H. Arends, Rohini Beavon, Kanika Dey, Pedro Garbes, Elizabeth J. Kelly, Gavin C.K.W. Koh, Karen A. Near, Kelly W. Padilla, Konstantina Psachoulia, Audrey Sharbaugh, Katie Streicher, Menelas N. Pangalos, Mark T. Esser · 发表于：New England Journal of Medicine · 年份：2022 · DOI：10.1056/nejmoa2116620 · 被引用次数：677 · 研究领域：COVID-19 Clinical Research Studies、Pharmacological Receptor Mechanisms and Effects、SARS-CoV-2 and COVID-19 Research

BACKGROUND: The monoclonal-antibody combination AZD7442 is composed of tixagevimab and cilgavimab, two neutralizing antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that have an extended half-life and have been shown to have prophylactic and therapeutic effects in animal models. Pharmacokinetic data in humans indicate that AZD7442 has an extended half-life of approximately 90 days. METHODS: In an ongoing phase 3 trial, we enrolled adults (≥18 years of age) who had an increased risk of an inadequate response to vaccination against coronavirus disease 2019 (Covid-19), an increased risk of exposure to SARS-CoV-2, or both. Participants were randomly assigned in a 2:1 ratio to receive a single dose (two consecutive intramuscular injections, one containing tixagevimab and the other containing cilgavimab) of either 300 mg of AZD7442 or saline placebo, and they were followed for up to 183 days in the primary analysis. The primary safety end point was the incidence of adverse events after a single dose of AZD7442. The primary efficacy end point was symptomatic Covid-19 (SARS-CoV-2 infection confirmed by means of reverse-transcriptase-polymerase-chain-reaction assay) occurring after administration of AZD7442 or placebo and on or before day 183. RESULTS: A total of 5197 participants underwent randomization and received one dose of AZD7442 or placebo (3460 in the AZD7442 group and 1737 in the placebo group). The primary analysis was conducted after 30% of t...