A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2
NCT ID: NCT06039449
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
790 participants
INTERVENTIONAL
2023-09-08
2024-11-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cohort A VYD222
VYD222 (pemivibart)
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Cohort B VYD222
VYD222 (pemivibart)
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Cohort B Placebo
Normal saline
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.
Interventions
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VYD222 (pemivibart)
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Normal saline
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.
Eligibility Criteria
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Inclusion Criteria
* Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening.
* For Cohort A, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies.
* For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings.
* Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28 days after dosing.
* Note: unless specified by Cohort, the criteria apply to both Cohorts
Exclusion Criteria
* Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization.
* Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.
* Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization.
* Is acutely ill or has any symptoms suggestive of infection, in the opinion of the Investigator.
12 Years
ALL
No
Sponsors
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Invivyd, Inc.
INDUSTRY
Responsible Party
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Locations
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INVIVYD Investigative Site
Fullerton, California, United States
INVIVYD Investigative Site
Long Beach, California, United States
INVIVYD Investigative Site
Rolling Hills Estates, California, United States
INVIVYD Investigative Site
San Diego, California, United States
INVIVYD Investigative Site
Clearwater, Florida, United States
INVIVYD Investigative Site
Miami, Florida, United States
INVIVYD Investigative Site
St. Petersburg, Florida, United States
INVIVYD Investigative Site
Atlanta, Georgia, United States
INVIVYD Investigative Site
Hinesville, Georgia, United States
INVIVYD Investigative Site
Oak Brook, Illinois, United States
INVIVYD Investigative Site
Silver Spring, Maryland, United States
INVIVYD Investigative Site
Burlington, Massachusetts, United States
INVIVYD Investigative Site
Morrisville, North Carolina, United States
INVIVYD Investigative Site
Salisbury, North Carolina, United States
INVIVYD Investigative Site
Edmond, Oklahoma, United States
INVIVYD Investigative Site
Yukon, Oklahoma, United States
INVIVYD Investigative Site
Beaumont, Texas, United States
INVIVYD Investigative Site
Dallas, Texas, United States
Countries
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References
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Wolfe CR, Cohen J, Mahoney K, Holmes A, Betancourt N, Gupta D, Tosh K, Narayan K, Campanaro E, Katz C, Phelan AM, Yalcin I, Wingertzahn M, Hawn P, Schmidt P, Li Y, Popejoy M. 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). Clin Infect Dis. 2025 May 24:ciaf265. doi: 10.1093/cid/ciaf265. Online ahead of print.
Other Identifiers
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VYD222-PREV-001
Identifier Type: -
Identifier Source: org_study_id