Skip to main content
OpenTrials
Completed

NCT Number: NCT06039449

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 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

INVIVYD Investigative Site, Fullerton, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VYD222 (pemivibart)

Drug

Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.

normal saline

Drug

Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.

Primary outcomes

  1. Cohort A - Incidence of treatment emergent adverse events

    Time frame: Through Month 12

  2. Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.

    Time frame: Day 28

  3. Cohort B - Incidence of treatment emergent adverse events

    Time frame: Through Month 12

Secondary outcomes

  1. Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.

    Time frame: Day 28

  2. Cohort A - sVNA titer by timepoint following VYD222 administration

    Time frame: Through Month 12

  3. Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint

    Time frame: Through Month 12

    The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.

  4. Cohort A - ADAs against VYD222

    Time frame: Through Month 12

  5. Cohort A - Serum concentrations (PK) of VYD222

    Time frame: Through Month 12

  6. Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19

    Time frame: Through Month 12

    RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.

  7. Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.

    Time frame: Day 28

  8. Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.

    Time frame: Day 28

  9. Cohort B - sVNA titer by timepoint following VYD222 administration

    Time frame: Through Month 12

  10. Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint

    Time frame: Through Month 12

    The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.

  11. Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset

    Time frame: Through Month 12

  12. Cohort B - COVID-19-related death

    Time frame: Through Month 12

  13. Cohort B - Serum concentrations (PK) of VYD222

    Time frame: Through Month 12

  14. Cohort B - ADAs against VYD222

    Time frame: Through Month 12

Sponsors and collaborators

Lead sponsor

Invivyd, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.