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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19, SARS-CoV-2

In brief

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

Key facts

Study ID

NCT06039449

Run by

Invivyd, Inc.

People needed

790

Starts

2023-09-08

Expected to finish

2024-11-19

Last updated by the study team

2024-12-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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