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

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

Tracking Information

• First Submitted Date: September 8, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: January 18, 2024
• Actual Study Start Date: September 8, 2023
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 16, 2024)

• Cohort A - Incidence of treatment emergent adverse events [ Time Frame: Through Month 12 ]
• 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 ]
• Cohort B - Incidence of treatment emergent adverse events [ Time Frame: Through Month 12 ]
• Cohort B - RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Month 6 ]

Original Primary Outcome Measures (submitted: September 8, 2023)

• Cohort A - Incidence of treatment emergent adverse events [ Time Frame: Through Month 12 ]
• 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 ]
• Cohort B - Incidence of treatment emergent adverse events [ Time Frame: Through Month 12 ]

Current Secondary Outcome Measures (submitted: January 16, 2024)

• 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 ]
• Cohort A - sVNA titer by timepoint following VYD222 administration [ Time Frame: Through Month 12 ]
• 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.
• Cohort A - ADAs against VYD222 [ Time Frame: Through Month 12 ]
• Cohort A - Serum concentrations (PK) of VYD222 [ Time Frame: Through Month 12 ]
• 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.
• Cohort B - RT-PCR-confirmed symptomatic COVID-19 [ Time Frame: Through Month 3 ]
• 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 ]
• 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 ]
• Cohort B - sVNA titer by timepoint following VYD222 administration [ Time Frame: Through Month 12 ]
• 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.
• 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.
• Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset [ Time Frame: Through Month 12 ]
• Cohort B - COVID-19-related death [ Time Frame: Through Month 12 ]
• Cohort B - Serum concentrations (PK) of VYD222 [ Time Frame: Through Month 12 ]
• Cohort B - ADAs against VYD222 [ Time Frame: Through Month 12 ]

Original Secondary Outcome Measures (submitted: September 8, 2023)

• 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 ]
• Cohort A - sVNA titer by timepoint following VYD222 administration [ Time Frame: Through Month 12 ]
• 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.
• Cohort A - ADAs against VYD222 [ Time Frame: Through Month 12 ]
• Cohort A - Serum concentrations (PK) of VYD222 [ Time Frame: Through Month 12 ]
• 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.
• 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 ]
• 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 ]
• Cohort B - sVNA titer by timepoint following VYD222 administration [ Time Frame: Through Month 12 ]
• 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.
• 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.
• Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset [ Time Frame: Through Month 12 ]
• Cohort B - COVID-19-related death [ Time Frame: Through Month 12 ]
• Cohort B - Serum concentrations (PK) of VYD222 [ Time Frame: Through Month 12 ]
• Cohort B - ADAs against VYD222 [ Time Frame: Through Month 12 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Only applies to Cohort B

Primary Purpose: Prevention

Condition

• COVID-19
• SARS-CoV-2

Intervention

• Drug: VYD222
  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.

Study Arms

• Experimental: Cohort A VYD222
  Intervention: Drug: VYD222
• Experimental: Cohort B VYD222
  Intervention: Drug: VYD222
• Placebo Comparator: Cohort B Placebo
  Intervention: Drug: Normal saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 13, 2023): 790
• Original Estimated Enrollment (submitted: September 8, 2023): 750
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06039449
• Other Study ID Numbers: VYD222-PREV-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Invivyd, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Invivyd, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Invivyd, Inc.
• Verification Date: November 2023