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

Study Overview
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Brief Summary
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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

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

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Drug: VYD222
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A VYD222<br> | Drug: VYD222<br>* Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.<br>|
| Experimental: Cohort B VYD222<br> | Drug: VYD222<br>* Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.<br>|
| Placebo Comparator: Cohort B Placebo<br> | Drug: Normal saline<br>* Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort A - Incidence of treatment emergent adverse events |  | 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. |  | Day 28 | 
| Cohort B - Incidence of treatment emergent adverse events |  | Through Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Day 28 | 
| Cohort A - sVNA titer by timepoint following VYD222 administration |  | 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 | The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis. | Through Month 12 | 
| Cohort A - ADAs against VYD222 |  | Through Month 12 | 
| Cohort A - Serum concentrations (PK) of VYD222 |  | Through Month 12 | 
| Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 | 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. | Through Month 12 | 
| 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. |  | 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. |  | Day 28 | 
| Cohort B - sVNA titer by timepoint following VYD222 administration |  | 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 | The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis. | Through Month 12 | 
| Cohort B - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19 | 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. | Through Month 12 | 
| Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset |  | Through Month 12 | 
| Cohort B - COVID-19-related death |  | Through Month 12 | 
| Cohort B - Serum concentrations (PK) of VYD222 |  | Through Month 12 | 
| Cohort B - ADAs against VYD222 |  | Through Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Compromise, VYD222, SARS-CoV-2 Monoclonal Antibody, COVID-19 Prevention