NCT06039449

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
790

participants targeted

Target at P50-P75 for phase_3 covid19

Timeline
Completed

Started Sep 2023

Typical duration for phase_3 covid19

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

September 8, 2023

Last Update Submit

December 6, 2024

Conditions

COVID-19SARS-CoV-2

Keywords

Immune CompromiseVYD222SARS-CoV-2 Monoclonal AntibodyCOVID-19 Prevention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • 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

    Through Month 12

  • Cohort A - ADAs against VYD222

    Through Month 12

  • Cohort A - Serum concentrations (PK) of VYD222

    Through Month 12

  • +9 more secondary outcomes

Study Arms (3)

Cohort A VYD222

EXPERIMENTAL
Drug: VYD222 (pemivibart)

Cohort B VYD222

EXPERIMENTAL
Drug: VYD222 (pemivibart)

Cohort B Placebo

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

VYD222 (pemivibart)DRUG

Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.

Cohort A VYD222Cohort B VYD222
Normal salineDRUG

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

Cohort B Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

INVIVYD Investigative Site

Fullerton, California, 92835, United States

Location

INVIVYD Investigative Site

Long Beach, California, 90806, United States

Location

INVIVYD Investigative Site

Rolling Hills Estates, California, 90274, United States

Location

INVIVYD Investigative Site

San Diego, California, 92103, United States

Location

INVIVYD Investigative Site

Clearwater, Florida, 33756, United States

Location

INVIVYD Investigative Site

Miami, Florida, 33186, United States

Location

INVIVYD Investigative Site

St. Petersburg, Florida, 33705, United States

Location

INVIVYD Investigative Site

Atlanta, Georgia, 30328, United States

Location

INVIVYD Investigative Site

Hinesville, Georgia, 31313, United States

Location

INVIVYD Investigative Site

Oak Brook, Illinois, 60523, United States

Location

INVIVYD Investigative Site

Silver Spring, Maryland, 20904, United States

Location

INVIVYD Investigative Site

Burlington, Massachusetts, 01803, United States

Location

INVIVYD Investigative Site

Morrisville, North Carolina, 27560, United States

Location

INVIVYD Investigative Site

Salisbury, North Carolina, 28144, United States

Location

INVIVYD Investigative Site

Edmond, Oklahoma, 73013, United States

Location

INVIVYD Investigative Site

Yukon, Oklahoma, 73099, United States

Location

INVIVYD Investigative Site

Beaumont, Texas, 77706, United States

Location

INVIVYD Investigative Site

Dallas, Texas, 75230, United States

Location

Related Publications (1)

  • Wolfe CR, Cohen J, Mahoney K, Holmes A, Betancourt N, Gupta D, Tosh K, Narayan K, Campanaro E, Katz C, Phelan AM, Yalcin I, Wingertzahn M, Hawn P, Schmidt P, Li Y, Popejoy M. Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY). Clin Infect Dis. 2025 Oct 6;81(3):439-450. doi: 10.1093/cid/ciaf265.

    PMID: 40410927DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Only applies to Cohort B
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

September 8, 2023

Primary Completion

November 19, 2024

Study Completion

November 19, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(18)