{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T17:43:11Z","timestamp":1791394991805,"version":"4.3.3"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,5,24]],"date-time":"2025-05-24T00:00:00Z","timestamp":1748044800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Invivyd, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,10,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>We report an interim analysis of safety and efficacy of pemivibart in individuals with (cohort A) or without (cohort B) significant immunocompromise in the phase 3 CANOPY trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eligible participants (aged \u226518 years; negative for current severe acute respiratory syndrome coronavirus 2 infection) received 2 intravenous 4500-mg pemivibart infusions (cohort A) or were randomized 2:1 to receive blinded pemivibart or placebo infusions (cohort B) 90 days apart. Safety was a primary end point for both cohorts. The primary immunobridging end point for cohort A has been reported elsewhere. Composite incidence of reverse-transcription polymerase chain reaction\u2013confirmed symptomatic coronavirus disease 2019 (COVID-19), COVID-19 hospitalization, and all-cause mortality was an exploratory end point.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In September\u2013November 2023, 306 participants received pemivibart (cohort A), and 317 received pemivibart and 162 placebo (cohort B). The most common study drug\u2013related adverse events were infusion-related reactions (cohort A: 11 of 306 [3.6%]; cohort B: 7 of 317 [2.2%] for pemivibart and 0 of 162 for placebo). Four of 623 participants (0.6%) who received pemivibart experienced anaphylactic reactions (serious in 2). In cohort A, the composite COVID-19 incidence through month 6 was 11 of 298 (3.7%; 2 deaths). In cohort B, 6 of 317 pemivibart (1.9%; no deaths) and 19 of 160 placebo (11.9%; no deaths) recipients met the end point through month 6 (84.1% standardized relative risk reduction [95% confidence interval, 60.9\u201393.5; nominal P &amp;lt; .001]), and 15 of 317 pemivibart (4.7%; 1 death) and 29 of 160 placebo (18.1%; no deaths) recipients met the end point through month 12 (73.9% standardized relative risk reduction [52.8\u201385.6; nominal P &amp;lt; .001]). Twelve-month protection was conferred with no additional dosing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Pemivibart provided prophylactic efficacy against COVID-19 and was well tolerated by most participants. Anaphylaxis was an important safety risk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT06039449<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf265","type":"journal-article","created":{"date-parts":[[2025,5,23]],"date-time":"2025-05-23T09:36:21Z","timestamp":1747992981000},"page":"439-450","source":"Crossref","is-referenced-by-count":17,"title":["Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY)"],"prefix":"10.1093","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5365-5030","authenticated-orcid":false,"given":"Cameron R","family":"Wolfe","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Duke University , Durham, North Carolina 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