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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07013474 | A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | PHASE3 | RECRUITING | 300 | — | — | Jul 14, 2025 | Feb 25, 2028 | Jun 5, 2026 | 141 | United States, Argentina +16 |
The difference in the proportion of participants with the composite endpoint of a) COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antiviral, or IV treatment; COVID-19-related hospitalization; or all-cause mortality, and b) Evidence of recurrent or persistent SARS-CoV-2 infection
| Arm | Type | Description |
|---|---|---|
| Ibuzatrelvir | EXPERIMENTAL | Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir |
| Ibuzatrelvir + Remdesivir | EXPERIMENTAL | Participants will receive ibuzatrelvir orally twice a day + IV remdesivir |
| Remdesivir | EXPERIMENTAL | Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir |
| Name | Type | Description |
|---|---|---|
| ibuzatrelvir | DRUG | tablet |
| remdesivir | DRUG | injection, for intravenous use |
| placebo for ibuzatrelvir | DRUG | tablet |
| placebo for remdesivir | DRUG | injection, for intravenous use |
Inclusion Criteria: 1. 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention. 2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to ...