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

Phase 3

Completed

• Conditions: COVID-19; SARS-CoV-2
• Interventions: Drug: VYD222 (pemivibart); Drug: Normal saline

• Registration Number: NCT06039449
• Lead Sponsor: Invivyd, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Primary Completion: 2024-11-19
• Study Completion: 2024-11-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 790

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B VYD222	VYD222 (pemivibart)	-
Cohort B Placebo	Normal saline	-
Cohort A VYD222	VYD222 (pemivibart)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cohort A - sVNA titer by timepoint following VYD222 administration	Through Month 12
Cohort A - ADAs against VYD222	Through Month 12
Cohort B - ADAs against VYD222	Through Month 12
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 - 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	The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Cohort A - Serum concentrations (PK) of VYD222	Through Month 12
Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19	Through Month 12	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.	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	Through Month 12	The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
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

Trial Locations

Locations (1)

INVIVYD Investigative Site; 🇺🇸 Dallas, Texas, United States