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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04530136 | Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19 | PHASE2 | COMPLETED | 38 | — | — | Nov 30, 2020 | Dec 1, 2021 | Feb 16, 2024 | 4 | United States |
The disease severity on the 7-point WHO Ordinal Scale on Day 7 was the primary objective of this study. This endpoint had been suggested by the WHO for clinical trials in patients with Covid-19. The ordinal scale measures illness severity over time. The higher score, the worst outcome: meaning score 1, no limitation in activities and score 7, death.
| Arm | Type | Description |
|---|---|---|
| Ruconest | EXPERIMENTAL | Patients receive (150 U/ml) of Ruconest at a 50 U/kg dose (max dose of 4200 U) as a slow intravenous injection via a peripheral every 12 hours; for 4 days. A total of 8 doses will be administered. |
| Standard of Care | OTHER | SOC |
| Name | Type | Description |
|---|---|---|
| Ruconest | DRUG | Patients will be randomized to Ruconest or Standard of Care |
Inclusion Criteria: * Age 18-85 years, * Admitted to the hospital because of confirmed positive SARS-CoV-2 (COVID-19 infection). * Evidence of pulmonary involvement on CT scan or X-Ray of the chest, * Symptom onset within the previous 10 days AND at least one additional risk factor for progression ...