Official Title
A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)
Brief Summary

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

Detailed Description

Not Provided

Completed
COVID-19
SARS-CoV-2

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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
United States
Locations

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

Invivyd, Inc.
NCT Number
Keywords
Immune Compromise
VYD222
SARS-CoV-2 Monoclonal Antibody
COVID-19 Prevention
MeSH Terms
COVID-19
Saline Solution