Status:
COMPLETED
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
Lead Sponsor:
Invivyd, Inc.
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2
Eligibility Criteria
Inclusion
- Is an adult aged ≥18 years or an adolescent aged 12 to \<18 years and weighs at least 40 kg at the time of Screening.
- 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
- For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization.
- 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.
- Note 1: Other protocol defined inclusion/exclusion criteria apply Note 2: Unless specified by Cohort, the criteria apply to both Cohorts
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT06039449
Start Date
September 8 2023
End Date
November 19 2024
Last Update
December 9 2024
Active Locations (18)
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1
INVIVYD Investigative Site
Fullerton, California, United States, 92835
2
INVIVYD Investigative Site
Long Beach, California, United States, 90806
3
INVIVYD Investigative Site
Rolling Hills Estates, California, United States, 90274
4
INVIVYD Investigative Site
San Diego, California, United States, 92103