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

I

Invivyd

Status and phase

Active, not recruiting
Phase 3

Conditions

COVID-19
SARS-CoV-2

Treatments

Drug: Normal saline
Drug: VYD222

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

790 participants in 3 patient groups, including a placebo group

Cohort A VYD222
Experimental group
Treatment:
Drug: VYD222
Cohort B VYD222
Experimental group
Treatment:
Drug: VYD222
Cohort B Placebo
Placebo Comparator group
Treatment:
Drug: Normal saline

Trial contacts and locations

0

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Central trial contact

Study Inquiry

Data sourced from clinicaltrials.gov

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