Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-28 @ 8:24 PM
Study NCT ID:
NCT04424134
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2020-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BromhexIne And Spironolactone For CoronŠ°VirUs Infection Requiring HospiTalization
Sponsor:
Lomonosov Moscow State University Medical Research and Educational Center
Organization:
Study Overview
Official Title:
Open Label Randomized Clinical Trial BromhexIne And Spironolactone For CoronŠ°VirUs Infection Requiring HospiTalization
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
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:
BISCUIT
Brief Summary:
Patients with mild and severe COVID 19 will be randomized 1:1 into two groups: experimental, which will get bromhexine and spironolactone, and control. Patients will get investigated therapy for ten days. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as a primary endpoint. Forty-five-day risk of death or mechanical ventilation will also be assessed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: