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

Invivyd

Status and phase: Active, not recruiting; Phase 3

Conditions: COVID-19; SARS-CoV-2

Treatments: Drug: VYD222 (pemivibart); Drug: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06039449

VYD222-PREV-001

Details and patient eligibility

About

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

Enrollment: 790 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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790 participants in 3 patient groups, including a placebo group

Cohort A VYD222

Experimental group

Treatment:

Drug: VYD222 (pemivibart)

Cohort B VYD222

Experimental group

Treatment:

Drug: VYD222 (pemivibart)

Cohort B Placebo

Placebo Comparator group

Treatment:

Drug: Normal saline