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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT06039449•Invivyd, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - No limit years

Sex

ALL

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.

Locations (18)

INVIVYD Investigative Site

Fullerton, California, United States

INVIVYD Investigative Site

Long Beach, California, United States

INVIVYD Investigative Site

Rolling Hills Estates, California, United States

INVIVYD Investigative Site

San Diego, California, United States

INVIVYD Investigative Site

Clearwater, Florida, United States

INVIVYD Investigative Site

Miami, Florida, United States

INVIVYD Investigative Site

St. Petersburg, Florida, United States

INVIVYD Investigative Site

Atlanta, Georgia, United States

INVIVYD Investigative Site

Hinesville, Georgia, United States

INVIVYD Investigative Site

Oak Brook, Illinois, United States

Key Dates

Start Date

September 8, 2023

Primary Completion Date

November 19, 2024

Completion Date

November 19, 2024

Last Updated

December 9, 2024

Enrollment

790

ACTUAL participants

Conditions

COVID-19SARS-CoV-2

Interventions

VYD222 (pemivibart)

DRUG

Normal saline

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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