{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T06:43:13Z","timestamp":1789627393573,"version":"build-2803163510"},"reference-count":33,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>Development of effective, scalable therapeutics for SARS-CoV-2 is a priority.<\/jats:p><\/jats:sec>Objective<\/jats:title>To test the efficacy of combined tixagevimab and cilgavimab monoclonal antibodies for early COVID-19 treatment.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>Two phase 2 randomized blinded placebo-controlled clinical trials within the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)\u20132\/A5401 platform were performed at US ambulatory sites. Nonhospitalized adults 18 years or older within 10 days of positive SARS-CoV-2 test and symptom onset were eligible and were enrolled from February 1 to May 31, 2021.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Tixagevimab-cilgavimab, 300 mg (150 mg of each component) given intravenously (IV) or 600 mg (300 mg of each component) given intramuscularly (IM) in the lateral thigh, or pooled placebo.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>Coprimary outcomes were time to symptom improvement through 28 days; nasopharyngeal SARS-CoV-2 RNA below the lower limit of quantification (LLOQ) on days 3, 7, or 14; and treatment-emergent grade 3 or higher adverse events through 28 days.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 229 participants were randomized for the IM study and 119 were randomized for the IV study. The primary modified intention-to-treat population included 223 participants who initiated IM tixagevimab-cilgavimab (n\u2009=\u2009106) or placebo treatment (n\u2009=\u2009117) (median age, 39 [IQR, 30-48] years; 113 [50.7%] were men) and 114 who initiated IV tixagevimab-cilgavimab (n\u2009=\u200958) or placebo treatment (n\u2009=\u200956) (median age, 44 [IQR, 35-54] years; 67 [58.8%] were women). Enrollment in the IV study was stopped early based on a decision to focus on IM product development. Participants were enrolled at a median of 6 (IQR, 4-7) days from COVID-19 symptom onset. Significant differences in time to symptom improvement were not observed for IM tixagevimab-cilgavimab vs placebo or IV tixagevimab-cilgavimab vs placebo. A greater proportion in the IM tixagevimab-cilgavimab arm (69 of 86 [80.2%]) than placebo (62 of 96 [64.6%]) had nasopharyngeal SARS-CoV-2 RNA below LLOQ at day 7 (adjusted risk ratio, 1.33 [95% CI, 1.12-1.57]) but not days 3 and 14; the joint test across time points favored treatment (P<\/jats:italic>\u2009=\u2009.003). Differences in the proportion below LLOQ were not observed for IV tixagevimab-cilgavimab vs placebo at any of the specified time points. There were no safety signals with either administration route.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>In these 2 phase 2 randomized clinical trials, IM or IV tixagevimab-cilgavimab was safe but did not change time to symptom improvement. Antiviral activity was more evident in the larger IM trial.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT04518410<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2023.10039","type":"journal-article","created":{"date-parts":[[2023,4,26]],"date-time":"2023-04-26T11:34:45Z","timestamp":1682508885000},"page":"e2310039","source":"Crossref","is-referenced-by-count":9,"title":["Safety and Efficacy of Combined Tixagevimab and Cilgavimab Administered Intramuscularly or Intravenously in Nonhospitalized Patients With COVID-19"],"prefix":"10.1001","volume":"6","author":[{"given":"Rachel A.","family":"Bender Ignacio","sequence":"first","affiliation":[{"name":"Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle"},{"name":"Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Center, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kara W.","family":"Chew","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, UCLA (University of California, Los Angeles)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlee","family":"Moser","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Harvard T. 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