Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prolastin · 1 trial · 1 indication
| 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...
Prolastin is an investigational monoclonal antibody being studied for the treatment of hospitalized patients with COVID-19. It is being developed by Grifols, S.A. and has completed a Phase 2 clinical trial evaluating its safety and efficacy in this patient population.
Prolastin is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential role in treating COVID-19, though the exact mechanism of action is not publicly detailed.
Prolastin is developed by Grifols, S.A., a biopharmaceutical company. Grifols is conducting clinical research on Prolastin for the treatment of COVID-19 in hospitalized patients.
Prolastin is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not been approved for any use and is still undergoing clinical evaluation.
Prolastin has one completed Phase 2 clinical trial, identified as NCT04495101, which evaluated the safety and efficacy of Prolastin in hospitalized subjects with COVID-19. The trial enrolled 100 participants in Spain and was active-controlled.
Prolastin is a distinct investigational monoclonal antibody developed by Grifols. It is not known to be the same as any other approved or investigational COVID-19 therapy, and no alternative names have been associated with it.