Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-01-03 @ 8:43 PM
Study NCT ID:
NCT04539795
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Study of Safety and Tolerability of Alvelestat
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
A Phase Ib/II, Single Center, Placebo-Controlled, Randomized, Blinded Study in Adult Patients (> 18 Years) With COVID-19 Respiratory Disease, to Evaluate, Safety, Tolerability and Mechanistic Effect of Alvelestat on Top of Standard of Care (COSTA)
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSTA
Brief Summary:
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK), and explore the mechanistic and clinical effect of alvelestat (an oral neutrophil elastase inhibitor) orally twice per day for 10 days added to standard of care in adult patients (≥18 years) with COVID-19 respiratory disease.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: