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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06039449
• Other study ID #: VYD222-PREV-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 8, 2023
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Invivyd, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 790
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	INVIVYD Investigative Site	Atlanta	Georgia
United States	INVIVYD Investigative Site	Beaumont	Texas
United States	INVIVYD Investigative Site	Burlington	Massachusetts
United States	INVIVYD Investigative Site	Clearwater	Florida
United States	INVIVYD Investigative Site	Culver City	California
United States	INVIVYD Investigative Site	Dallas	Texas
United States	INVIVYD Investigative Site	Edmond	Oklahoma
United States	INVIVYD Investigative Site	Fullerton	California
United States	INVIVYD Investigative Site	Hinesville	Georgia
United States	INVIVYD Investigative Site	Long Beach	California
United States	INVIVYD Investigative Site	Miami	Florida
United States	INVIVYD Investigative Site	Oak Brook	Illinois
United States	INVIVYD Investigative Site	Rolling Hills Estates	California
United States	INVIVYD Investigative Site	Saint Petersburg	Florida
United States	INVIVYD Investigative Site	Salisbury	North Carolina
United States	INVIVYD Investigative Site	San Diego	California
United States	INVIVYD Investigative Site	Silver Spring	Maryland
United States	INVIVYD Investigative Site	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Invivyd, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort A - Incidence of treatment emergent adverse events		Through Month 12
Primary	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
Primary	Cohort B - Incidence of treatment emergent adverse events		Through Month 12
Primary	Cohort B - RT-PCR-confirmed symptomatic COVID-19		Through Month 6
Secondary	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
Secondary	Cohort A - sVNA titer by timepoint following VYD222 administration		Through Month 12
Secondary	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
Secondary	Cohort A - ADAs against VYD222		Through Month 12
Secondary	Cohort A - Serum concentrations (PK) of VYD222		Through Month 12
Secondary	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
Secondary	Cohort B - RT-PCR-confirmed symptomatic COVID-19		Through Month 3
Secondary	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
Secondary	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
Secondary	Cohort B - sVNA titer by timepoint following VYD222 administration		Through Month 12
Secondary	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
Secondary	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
Secondary	Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset		Through Month 12
Secondary	Cohort B - COVID-19-related death		Through Month 12
Secondary	Cohort B - Serum concentrations (PK) of VYD222		Through Month 12
Secondary	Cohort B - ADAs against VYD222		Through Month 12