Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ratutrelvir non-randomised · 1 trial · 1 indication
Adverse events incidence will be described using descriptive statistics methods
Adverse events severity will be assessed by current version of CTCAE
| Arm | Type | Description |
|---|---|---|
| Ratutrelvir (83-0060) non-randomised | EXPERIMENTAL | - |
| Paxlovid | ACTIVE_COMPARATOR | Standard of care |
| Ratutrelvir (83-0060) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ratutrelvir (83-0060) non-randomised | DRUG | 83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL) |
| Paxlovid | DRUG | Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor) |
| Ratutrelvir (83-0060) | DRUG | 83-0060, a covalent inhibitor of the SARS-CoV-2 main protease (Mpro; 3CL) |
Inclusion Criteria: 1. Confirmed SARS-CoV-2 infection for 120 h prior to randomization. 2. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization. 3. At least one of the symptoms attributable to COVID-19 present within 24 hours prior to the Day 1 with the seve...