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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

Primary Purpose

COVID-19, SARS-CoV-2

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VYD222
Normal saline
Sponsored by
Invivyd, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Immune Compromise, VYD222, SARS-CoV-2 Monoclonal Antibody, COVID-19 Prevention

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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. Note 1: Other protocol defined inclusion/exclusion criteria apply Note 2: Unless specified by Cohort, the criteria apply to both Cohorts

Sites / Locations

  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative Site
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting
  • INVIVYD Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort A VYD222

Cohort B VYD222

Cohort B Placebo

Arm Description

Outcomes

Primary Outcome Measures

Cohort A - Incidence of treatment emergent adverse events
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.
Cohort B - Incidence of treatment emergent adverse events

Secondary Outcome Measures

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.
Cohort A - sVNA titer by timepoint following VYD222 administration
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.
Cohort A - ADAs against VYD222
Cohort A - Serum concentrations (PK) of VYD222
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.
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.
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.
Cohort B - sVNA titer by timepoint following VYD222 administration
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.
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.
Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset
Cohort B - COVID-19-related death
Cohort B - Serum concentrations (PK) of VYD222
Cohort B - ADAs against VYD222

Full Information

First Posted
September 8, 2023
Last Updated
September 29, 2023
Sponsor
Invivyd, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06039449
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invivyd, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
Immune Compromise, VYD222, SARS-CoV-2 Monoclonal Antibody, COVID-19 Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Only applies to Cohort B
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A VYD222
Arm Type
Experimental
Arm Title
Cohort B VYD222
Arm Type
Experimental
Arm Title
Cohort B Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VYD222
Intervention Description
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.
Primary Outcome Measure Information:
Title
Cohort A - Incidence of treatment emergent adverse events
Time Frame
Through Month 12
Title
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
Title
Cohort B - Incidence of treatment emergent adverse events
Time Frame
Through Month 12
Secondary Outcome Measure Information:
Title
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
Title
Cohort A - sVNA titer by timepoint following VYD222 administration
Time Frame
Through Month 12
Title
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
Description
The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Time Frame
Through Month 12
Title
Cohort A - ADAs against VYD222
Time Frame
Through Month 12
Title
Cohort A - Serum concentrations (PK) of VYD222
Time Frame
Through Month 12
Title
Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
Description
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.
Time Frame
Through Month 12
Title
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
Title
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
Title
Cohort B - sVNA titer by timepoint following VYD222 administration
Time Frame
Through Month 12
Title
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
Description
The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Time Frame
Through Month 12
Title
Cohort B - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
Description
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.
Time Frame
Through Month 12
Title
Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset
Time Frame
Through Month 12
Title
Cohort B - COVID-19-related death
Time Frame
Through Month 12
Title
Cohort B - Serum concentrations (PK) of VYD222
Time Frame
Through Month 12
Title
Cohort B - ADAs against VYD222
Time Frame
Through Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Inquiry
Phone
+1 781-819-0080
Email
ClinicalTrials@invivyd.com
Facility Information:
Facility Name
INVIVYD Investigative Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
INVIVYD Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Hinesville
State/Province
Georgia
ZIP/Postal Code
31313
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01803
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Individual Site Status
Recruiting
Facility Name
INVIVYD Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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