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

Purpose

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

Conditions

  • COVID-19
  • SARS-CoV-2

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Only applies to Cohort B

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A VYD222
  • Drug: VYD222 (pemivibart)
    Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Experimental
Cohort B VYD222
  • Drug: VYD222 (pemivibart)
    Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Placebo Comparator
Cohort B Placebo
  • Drug: Normal saline
    Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.

Recruiting Locations

More Details

NCT ID
NCT06039449
Status
Active, not recruiting
Sponsor
Invivyd, Inc.