Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547140
Status:
TERMINATED
Last Update Posted:
2023-03-22
First Post:
2020-09-10
Brief Title:
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor Human in Hospitalized Participants With Coronavirus Disease COVID-19
Sponsor:
Grifols Therapeutics LLC
Organization:
Grifols Therapeutics LLC
Study Overview
Official Title:
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
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study Stopped for Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None