Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04481685
Status:
COMPLETED
Last Update Posted:
2021-06-23
First Post:
2020-07-15
Brief Title:
A Trial of Aclaris Therapeutics Inc ATI-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 COVID-19
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
A Double-blind Randomized Controlled Trial of ATI-450 in Patients With Moderate-severe COVID-19
Status:
COMPLETED
Status Verified Date:
2020-05
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:
None
Brief Summary:
COVID-19 morbidity and mortality has been associated with Cytokine Release Syndrome CRS and Acute Respiratory Distress Syndrome ARDS
ATI-450 is an oral small molecule MAPKAPK2 MK2 inhibitor that potently inhibits multiple inflammatory cytokines
The investigator hypothesizes that MK2 pathway blockade during active COVID-19 infection in hospitalized participants will result in improvement in respiratory-failure free survival
ATI-450 is an oral small molecule MAPKAPK2 MK2 inhibitor that potently inhibits multiple inflammatory cytokines
The investigator hypothesizes that MK2 pathway blockade during active COVID-19 infection in hospitalized participants will result in improvement in respiratory-failure free survival
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