Clinical trial NCT06039449: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
SARS-CoV-2
Keywords: Immune Compromise
VYD222
SARS-CoV-2 Monoclonal Antibody
COVID-19 Prevention
Lead sponsor: Invivyd, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 790
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Cohort A - Incidence of treatment emergent adverse events
timeFrame: Through Month 12
measure: 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.
timeFrame: Day 28
measure: Cohort B - Incidence of treatment emergent adverse events
timeFrame: Through Month 12
Secondary outcomes:
measure: 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.
timeFrame: Day 28
measure: Cohort A - sVNA titer by timepoint following VYD222 administration
timeFrame: Through Month 12
measure: 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
timeFrame: Through Month 12
measure: Cohort A - ADAs against VYD222
timeFrame: Through Month 12
measure: Cohort A - Serum concentrations (PK) of VYD222
timeFrame: Through Month 12
measure: Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
timeFrame: Through Month 12
measure: 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.
timeFrame: Day 28
measure: 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.
timeFrame: Day 28
measure: Cohort B - sVNA titer by timepoint following VYD222 administration
timeFrame: Through Month 12
measure: 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
timeFrame: Through Month 12
measure: Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset
timeFrame: Through Month 12
measure: Cohort B - COVID-19-related death
timeFrame: Through Month 12
measure: Cohort B - Serum concentrations (PK) of VYD222
timeFrame: Through Month 12
measure: Cohort B - ADAs against VYD222
timeFrame: Through Month 12
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: INVIVYD Investigative Site
state: California
city: Long Beach
country: United States
facility: INVIVYD Investigative Site
state: California
city: Rolling Hills Estates
country: United States
facility: INVIVYD Investigative Site
state: California
city: San Diego
country: United States
facility: INVIVYD Investigative Site
state: California
city: Clearwater
country: United States
facility: INVIVYD Investigative Site
state: Florida
city: Miami
country: United States
facility: INVIVYD Investigative Site
state: Florida
city: St. Petersburg
country: United States
facility: INVIVYD Investigative Site
state: Florida
city: Atlanta
country: United States
facility: INVIVYD Investigative Site
state: Georgia
city: Hinesville
country: United States
facility: INVIVYD Investigative Site
state: Georgia
city: Oak Brook
country: United States
facility: INVIVYD Investigative Site
state: Illinois
city: Silver Spring
country: United States
facility: INVIVYD Investigative Site
state: Maryland
city: Burlington
country: United States
facility: INVIVYD Investigative Site
state: Massachusetts
city: Morrisville
country: United States
facility: INVIVYD Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: INVIVYD Investigative Site
state: North Carolina
city: Edmond
country: United States
facility: INVIVYD Investigative Site
state: Oklahoma
city: Yukon
country: United States
facility: INVIVYD Investigative Site
state: Oklahoma
city: Beaumont
country: United States
facility: INVIVYD Investigative Site
state: Texas
city: Dallas
country: United States
facility: INVIVYD Investigative Site
state: Texas
Study officials:
References: