drugset / Trial / NCT04547140

Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)

NCT04547140

Phase 2 Terminated 57 enrolled Grifols Therapeutics LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.

Timeline

Start
2021-01-29
Primary completion
2021-12-13
Completion
2022-01-28

Drugs

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

Indications