A study to investigate the prevention of COVID-19 with VYD222 in adults with immunecompromise and in participants aged 12 years or older who are at risk of exposure toSARS-CoV-2
Not Provided
Drug: VYD222 (pemivibart)
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90
days) with VYD222.
Drug: Normal saline
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90
days) with Placebo.
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
INVIVYD Investigative Site
Fullerton	5351247, California	5332921, United States
INVIVYD Investigative Site
Long Beach	5367929, California	5332921, United States
INVIVYD Investigative Site
Rolling Hills Estates	5388601, California	5332921, United States
INVIVYD Investigative Site
San Diego	5391811, California	5332921, United States
INVIVYD Investigative Site
Clearwater	4151316, Florida	4155751, United States
INVIVYD Investigative Site
Miami	4164138, Florida	4155751, United States
INVIVYD Investigative Site
St. Petersburg	4171563, Florida	4155751, United States
INVIVYD Investigative Site
Atlanta	4180439, Georgia	4197000, United States
INVIVYD Investigative Site
Hinesville	4200671, Georgia	4197000, United States
INVIVYD Investigative Site
Oak Brook	4904277, Illinois	4896861, United States
INVIVYD Investigative Site
Silver Spring	4369596, Maryland	4361885, United States
INVIVYD Investigative Site
Burlington	4931737, Massachusetts	6254926, United States
INVIVYD Investigative Site
Morrisville	4480285, North Carolina	4482348, United States
INVIVYD Investigative Site
Salisbury	4489985, North Carolina	4482348, United States
INVIVYD Investigative Site
Edmond	4535740, Oklahoma	4544379, United States
INVIVYD Investigative Site
Yukon	4556165, Oklahoma	4544379, United States
INVIVYD Investigative Site
Beaumont	4672989, Texas	4736286, United States
INVIVYD Investigative Site
Dallas	4684888, Texas	4736286, United States
Not Provided