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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A VYD222 | Experimental |
| |
| Cohort B VYD222 | Experimental |
| |
| Cohort B Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VYD222 (pemivibart) | Drug | Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222. |
|
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INVIVYD Investigative Site | Fullerton | California | 92835 | United States | ||
| INVIVYD Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41697535 | Derived | Yalcin I, Hu L, West B, Narayan K, Holmes A, Wingertzahn MA. A Statistical Immune Correlates of Protection Model for Predicting Efficacy from Neutralizing Antibody Titers to Establish Immunobridging of Monoclonal Antibodies for Prevention of COVID-19. Infect Dis Ther. 2026 Apr;15(4):1007-1017. doi: 10.1007/s40121-026-01315-6. Epub 2026 Feb 16. | |
| 40410927 |
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Only applies to Cohort B
| Normal saline | Drug | Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo. |
|
| 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 |
| Long Beach |
| California |
| 90806 |
| United States |
| INVIVYD Investigative Site | Rolling Hills Estates | California | 90274 | United States |
| INVIVYD Investigative Site | San Diego | California | 92103 | United States |
| INVIVYD Investigative Site | Clearwater | Florida | 33756 | United States |
| INVIVYD Investigative Site | Miami | Florida | 33186 | United States |
| INVIVYD Investigative Site | St. Petersburg | Florida | 33705 | United States |
| INVIVYD Investigative Site | Atlanta | Georgia | 30328 | United States |
| INVIVYD Investigative Site | Hinesville | Georgia | 31313 | United States |
| INVIVYD Investigative Site | Oak Brook | Illinois | 60523 | United States |
| INVIVYD Investigative Site | Silver Spring | Maryland | 20904 | United States |
| INVIVYD Investigative Site | Burlington | Massachusetts | 01803 | United States |
| INVIVYD Investigative Site | Morrisville | North Carolina | 27560 | United States |
| INVIVYD Investigative Site | Salisbury | North Carolina | 28144 | United States |
| INVIVYD Investigative Site | Edmond | Oklahoma | 73013 | United States |
| INVIVYD Investigative Site | Yukon | Oklahoma | 73099 | United States |
| INVIVYD Investigative Site | Beaumont | Texas | 77706 | United States |
| INVIVYD Investigative Site | Dallas | Texas | 75230 | United States |
| 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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