drugset / Trial / NCT04495101
Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
Timeline
- Start
- 2020-07-29
- Primary completion
- 2021-04-26
- Completion
- 2021-06-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 120 mg/kg | Intravenous |