Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ibuzatrelvir · 4 trials · 4 indications
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
The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.
if data permits
| 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 |
| placebo | PLACEBO_COMPARATOR | placebo administered orally every 12 hours (twice daily) for 5 days. |
| Period 1 | EXPERIMENTAL | ibuzatrelvir single oral dose on Day 1. |
| Period 2 | EXPERIMENTAL | carbamazepine BID oral doses on Day 1-15. ibuzatrelvir single oral dose on Day 14. |
| 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 |
| placebo | DRUG | placebo tablets |
| carbamazepine ER | DRUG | 100 mg BID (Day 1-3) 200 mg BID (Day 4-7) 300 mg BID (Day 8-15) |
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 ...