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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04495101 | Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19 | PHASE2 | COMPLETED | 100 | — | — | Jul 29, 2020 | Jun 10, 2021 | Jul 8, 2021 | 9 | Spain |
| Arm | Type | Description |
|---|---|---|
| Prolastin 120 mg/kg + Standard Medical Treatment | EXPERIMENTAL | Subjects will receive Prolastin, two intravenous infusion (IV) doses of 120 milligram per kilogram (mg/kg), based upon the subject's body weight, on Day 1 and Day 8. Subjects will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Standard Medical Treatment | ACTIVE_COMPARATOR | Subjects will receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Name | Type | Description |
|---|---|---|
| Prolastin | BIOLOGICAL | Intravenous infusion 120 mg/kg |
| Standard Medical Treatment | DRUG | Standard medical treatment per local policies or guidelines |
Inclusion Criteria: 1. Hospitalized male or female subject ≥ 18 years of age at the time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (≤ 48 hours) of hospital admission. 2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined b...