drugset / Trial / NCT04495101

Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19

NCT04495101

Phase 2 Completed 100 enrolled Grifols, S.A.
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

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic 120 mg/kg Intravenous

Indications