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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.