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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05321394 | Non-inferiority Trial on Treatments in Early COVID-19 | PHASE3 | COMPLETED | 536 | — | — | Mar 7, 2022 | Oct 29, 2023 | Nov 7, 2023 | 19 | Italy |
(1) hospitalization or (2) need of supplemental oxygen therapy at home or (3) death within 14 days of randomisation
| Arm | Type | Description |
|---|---|---|
| Sotrovimab | ACTIVE_COMPARATOR | Sotrovimab 500 mg administered in 100 mL prefilled 0.9% sodium chloride injection infusion solution over 1/2 hour |
| Tixagevimab Cilgavimab | EXPERIMENTAL | 300 mg of tixagevimab and 300 mg of cilgavimab administered as two separate consecutive intramuscular injections |
| Nirmatrelvir Ritonavir | EXPERIMENTAL | 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) with all three tablets taken together twice daily for 5 days |
| Name | Type | Description |
|---|---|---|
| Sotrovimab | DRUG | Single intravenous infusion of sotrovimab 500 mg (500 mg/8 mL), administered in 100 mL prefilled 0.9% sodium chloride injection infusion solution over 1/2 hour. |
| Tixagevimab Cilgavimab | DRUG | 2 subsequent injections: 1. tixagevimab 300mg/3mL (100mg/mL) 2. cilgavimab 300mg/3mL (100mg/mL) |
| Nirmatrelvir Ritonavir | DRUG | 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) with all three tablets taken together twice daily for 5 days |
Inclusion Criteria: * Age ≥ 50 years * Informed consent by the subject or legally authorized representative * Laboratory-confirmed SARS-CoV-2 infection, as determined by PCR or other commercial or public health assay in any specimen, no more than 4 days prior to the study drug administration * Peri...