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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Drug: Normal saline; Drug: VYD222 (pemivibart)

• Study Type: Interventional
• Enrollment (Actual): 790
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92835
      • Invivyd Investigative Site
    • Long Beach, California, United States, 90806
      • Invivyd Investigative Site
    • Rolling Hills Estates, California, United States, 90274
      • Invivyd Investigative Site
    • San Diego, California, United States, 92103
      • Invivyd Investigative Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • Invivyd Investigative Site
    • Miami, Florida, United States, 33186
      • Invivyd Investigative Site
    • St. Petersburg, Florida, United States, 33705
      • Invivyd Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Invivyd Investigative Site
    • Hinesville, Georgia, United States, 31313
      • Invivyd Investigative Site
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • Invivyd Investigative Site
  • Maryland
    • Silver Spring, Maryland, United States, 20904
      • Invivyd Investigative Site
  • Massachusetts
    • Burlington, Massachusetts, United States, 01803
      • Invivyd Investigative Site
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Invivyd Investigative Site
    • Salisbury, North Carolina, United States, 28144
      • Invivyd Investigative Site
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Invivyd Investigative Site
    • Yukon, Oklahoma, United States, 73099
      • Invivyd Investigative Site
  • Texas
    • Beaumont, Texas, United States, 77706
      • Invivyd Investigative Site
    • Dallas, Texas, United States, 75230
      • Invivyd Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 - 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

Collaborators and Investigators

• Sponsor: Invivyd, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): November 19, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19 Prevention; SARS-CoV-2 Monoclonal Antibody; Immune Compromise; VYD222
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: VYD222-PREV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No