Trials / Terminated
TerminatedNCT04547140
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) Plus Standard Medical Treatment (SMT) Versus Placebo Plus SMT in Hospitalized Subjects With COVID-19
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Grifols Therapeutics LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Liquid Alpha1-Proteinase Inhibitor (Human) | Intravenous infusion 120 mg/kg |
| DRUG | Placebo | Intravenous infusion |
| DRUG | Standard Medical Treatment | SMT |
Timeline
- Start date
- 2021-01-29
- Primary completion
- 2021-12-13
- Completion
- 2022-01-28
- First posted
- 2020-09-14
- Last updated
- 2023-03-22
- Results posted
- 2023-03-22
Locations
20 sites across 5 countries: United States, Brazil, Chile, Colombia, Mexico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04547140. Inclusion in this directory is not an endorsement.