Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 790 | — | — | Sep 8, 2023 | Nov 19, 2024 | Dec 9, 2024 | 18 | United States |
| NCT05791318 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants | PHASE1 | COMPLETED | 30 | — | — | Mar 28, 2023 | May 8, 2024 | May 31, 2024 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| Cohort A VYD222 | EXPERIMENTAL | - |
| Cohort B VYD222 | EXPERIMENTAL | - |
| Cohort B Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | 10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo |
| Cohort 2 | EXPERIMENTAL | 10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo |
| Cohort 3 | EXPERIMENTAL | 10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo |
| Name | Type | Description |
|---|---|---|
| VYD222 (pemivibart) | DRUG | Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222. |
| Normal saline | DRUG | Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo. |
| VYD222 | DRUG | Monoclonal antibody |
| Placebo | OTHER | Matching Placebo |
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 f...