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:

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 mortalit

SUBMITTER: Wolfe CR 

PROVIDER: S-EPMC12497959 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature