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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

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ClinicalTrials.gov Identifier: NCT06039449
Recruitment Status : Active, not recruiting
First Posted : September 15, 2023
Last Update Posted : January 18, 2024
Sponsor:
Information provided by (Responsible Party):
Invivyd, Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Drug: VYD222 Drug: Normal saline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only applies to Cohort B
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)
Actual Study Start Date : September 8, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A VYD222 Drug: VYD222
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Experimental: Cohort B VYD222 Drug: VYD222
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Placebo Comparator: Cohort B Placebo Drug: Normal saline
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.


Outcome Measures
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Primary Outcome Measures :
  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 ]
  4. Cohort B - RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Month 6 ]

Secondary Outcome Measures :
  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 - RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Month 3 ]
  8. 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 ]
  9. 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 ]
  10. Cohort B - sVNA titer by timepoint following VYD222 administration [ Time Frame: Through Month 12 ]
  11. 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.

  12. Cohort B - 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.

  13. Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset [ Time Frame: Through Month 12 ]
  14. Cohort B - COVID-19-related death [ Time Frame: Through Month 12 ]
  15. Cohort B - Serum concentrations (PK) of VYD222 [ Time Frame: Through Month 12 ]
  16. Cohort B - ADAs against VYD222 [ Time Frame: Through Month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039449


Locations
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United States, California
INVIVYD Investigative Site
Culver City, California, United States, 90230
INVIVYD Investigative Site
Fullerton, California, United States, 92835
INVIVYD Investigative Site
Long Beach, California, United States, 90806
INVIVYD Investigative Site
Rolling Hills Estates, California, United States, 90274
INVIVYD Investigative Site
San Diego, California, United States, 92103
United States, Florida
INVIVYD Investigative Site
Clearwater, Florida, United States, 33756
INVIVYD Investigative Site
Miami, Florida, United States, 33186
INVIVYD Investigative Site
Saint Petersburg, Florida, United States, 33705
United States, Georgia
INVIVYD Investigative Site
Atlanta, Georgia, United States, 30328
INVIVYD Investigative Site
Hinesville, Georgia, United States, 31313
United States, Illinois
INVIVYD Investigative Site
Oak Brook, Illinois, United States, 60523
United States, Maryland
INVIVYD Investigative Site
Silver Spring, Maryland, United States, 20904
United States, Massachusetts
INVIVYD Investigative Site
Burlington, Massachusetts, United States, 01803
United States, North Carolina
INVIVYD Investigative Site
Salisbury, North Carolina, United States, 28144
United States, Oklahoma
INVIVYD Investigative Site
Edmond, Oklahoma, United States, 73013
INVIVYD Investigative Site
Yukon, Oklahoma, United States, 73099
United States, Texas
INVIVYD Investigative Site
Beaumont, Texas, United States, 77706
INVIVYD Investigative Site
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Invivyd, Inc.
More Information
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Responsible Party: Invivyd, Inc.
ClinicalTrials.gov Identifier: NCT06039449    
Other Study ID Numbers: VYD222-PREV-001
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Invivyd, Inc.:
Immune Compromise
VYD222
SARS-CoV-2 Monoclonal Antibody
COVID-19 Prevention
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases