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)
Abstract
Abstract Background 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. Methods Eligible participants (aged ≥18 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–confirmed symptomatic coronavirus disease 2019 (COVID-19), COVID-19 hospitalization, and all-cause mortality was an exploratory end point. Results In September–November 2023, 306 participants received pemivibart (cohort A), and 317 received pemivibart and 162 placebo (cohort B). The most common study drug–related 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%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 623 participants or records.
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