Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
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).
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06039449 (A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- 2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Pemivibart for Pre-exposure Prophylaxis, Vilobelimab for Critical Illness, and Abatacept or Infliximab for Severe or Critical Illness.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Guideline
- Immunobridging Analysis of Pemivibart for the Treatment of COVID-19: A Therapeutic Gap for the Immune-Compromised Population Remains.Open forum infectious diseases · 2026Trial
- Organoid-based evaluation of SA55 and Pemivibart against evolving SARS-CoV-2 variants.Emerging microbes & infections · 2026Article
- Article
- Structure and function of therapeutic antibodies approved by the US FDA in 2025.Antibody therapeutics · 2026Review
- CROI 2026: Acute and Postacute COVID-19.Topics in antiviral medicine · 2026Article
- A Statistical Immune Correlates of Protection Model for Predicting Efficacy from Neutralizing Antibody Titers to Establish Immunobridging of Monoclonal Antibodies for Prevention of COVID-19.Infectious diseases and therapy · 2026Article
- Strategies for mitigating severe COVID-19 in patients with haematological malignancy during the omicron era.The Journal of antimicrobial chemotherapy · 2026Review
- The Impact of the COVID-19 Pandemic on an Immunocompromised Patient with Allogeneic Haematopoietic Stem Cell Transplant: A Dual Perspective from Patient and Physician Standpoints.Oncology and therapy · 2025Article
- Best Supportive Care for Patients with Chronic Lymphocytic Leukemia: Relevance of Cancer Screening and Immunizations.Cancers · 2025Review
- The Emergence of Escape Mutations in COVID-19 Following Anti-Spike Monoclonal Antibody Treatment: How Do We Tackle It?Infection and drug resistance · 2025Review
Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
backgroundWe 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.
methodsEligible 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.
resultsIn 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% standardized relative risk reduction [95% confidence interval, 60.9-93.5; nominal P < .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 [52.8-85.6; nominal P < .001]). Twelve-month protection was conferred with no additional dosing.
conclusionsPemivibart provided prophylactic efficacy against COVID-19 and was well tolerated by most participants. Anaphylaxis was an important safety risk. CLINICAL TRIALS REGISTRATION: NCT06039449.
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