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

• Status: Active, not recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Invivyd, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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