{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T00:04:42Z","timestamp":1788825882915,"version":"build-2803163510"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2022,11,22]],"date-time":"2022-11-22T00:00:00Z","timestamp":1669075200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"AstraZeneca"},{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"crossref","award":["W911QY-21-9-0001"],"award-info":[{"award-number":["W911QY-21-9-0001"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,4,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>This phase 3 trial assessed AZD7442 (tixagevimab\/cilgavimab) for post-exposure prophylaxis against symptomatic coronavirus disease 2019 (COVID-19).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adults without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 vaccination were enrolled within 8 days of exposure to a SARS-CoV-2\u2013infected individual and randomized 2:1 to a single 300-mg AZD7442 dose (one 1.5-mL intramuscular injection each of tixagevimab and cilgavimab) or placebo. Primary end points were safety and first post-dose SARS-CoV-2 reverse-transcription polymerase chain reaction (RT-PCR)\u2013positive symptomatic COVID-19 event before day 183.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 1121 participants were randomized and dosed (AZD7442, n = 749; placebo, n = 372). Median (range) follow-up was 49 (5\u2013115) and 48 (20\u2013113) days for AZD7442 and placebo, respectively. Adverse events occurred in 162 of 749 (21.6%) and 111 of 372 (29.8%) participants with AZD7442 and placebo, respectively, mostly mild\/moderate. RT-PCR\u2013positive symptomatic COVID-19 occurred in 23 of 749 (3.1%) and 17 of 372 (4.6%) AZD7442- and placebo-treated participants, respectively (relative risk reduction, 33.3%; 95% confidence interval [CI], \u221225.9 to 64.7; P = .21). In predefined subgroup analyses of 1073 (96%) participants who were SARS-CoV-2 RT-PCR\u2013negative (n = 974, 87%) or missing an RT-PCR result (n = 99, 9%) at baseline, AZD7442 reduced RT-PCR\u2013positive symptomatic COVID-19 by 73.2% (95% CI, 27.1 to 90.1) vs placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study did not meet the primary efficacy end point of post-exposure prevention of symptomatic COVID-19. However, analysis of participants who were SARS-CoV-2 RT-PCR\u2013negative or missing an RT-PCR result at baseline support a role for AZD7442 in preventing symptomatic COVID-19.<\/jats:p><jats:p>Clinical Trials Registration. NCT04625972.<\/jats:p><\/jats:sec>","DOI":"10.1093\/cid\/ciac899","type":"journal-article","created":{"date-parts":[[2022,11,17]],"date-time":"2022-11-17T22:45:09Z","timestamp":1668725109000},"page":"1247-1256","source":"Crossref","is-referenced-by-count":28,"title":["AZD7442 (Tixagevimab\/Cilgavimab) for Post-Exposure Prophylaxis of Symptomatic Coronavirus Disease 2019"],"prefix":"10.1093","volume":"76","author":[{"given":"Myron J","family":"Levin","sequence":"first","affiliation":[{"name":"University of Colorado Denver School of Medicine , Aurora, Colorado , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Ustianowski","sequence":"additional","affiliation":[{"name":"North Manchester General Hospital , Manchester , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Thomas","sequence":"additional","affiliation":[{"name":"Biometrics, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gaithersburg, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Templeton","sequence":"additional","affiliation":[{"name":"Biometrics, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Cambridge , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Yuan","sequence":"additional","affiliation":[{"name":"Biometrics, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Gaithersburg, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth","family":"Seegobin","sequence":"additional","affiliation":[{"name":"Biometrics, Vaccines and Immune Therapies, BioPharmaceuticals Research and Development, AstraZeneca , Cambridge , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine F","family":"Houlihan","sequence":"additional","affiliation":[{"name":"Department of Clinical Virology, University College London Hospitals National Health Service Foundation Trust , London , United Kingdom"},{"name":"Department of Infection and Immunity, University College London , London , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim","family":"Menendez-Perez","sequence":"additional","affiliation":[{"name":"Project 4 Research , Miami, Florida , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Pollett","sequence":"additional","affiliation":[{"name":"Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences , Bethesda, Maryland , USA"},{"name":"Henry M. 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