Spironolactone in Covid-19 Induced ARDS
Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Completed
CT.gov ID
NCT04345887
Collaborator
(none)
60
1
2
29.9
Study Details
Study Description
Brief Summary
This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Spironolactone on Oxygenation in Covid-19 ARDS Patients
Actual Study Start Date
:
May 5, 2020
Actual Primary Completion Date
:
Jun 15, 2020
Actual Study Completion Date
:
Jul 5, 2020
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Spironolactone 2 x 100 mg spironolactone |
Drug: Spironolactone 100mg
2x100 mg spironolactone for 5 consecutive days
|
Placebo 2 x 1 placebo |
Drug: Placebo oral tablet
2 x1 placebo tablet
|
Outcome Measures
Primary Outcome Measures
- p/f ratio [5 days]
improvement in oxygenation
Secondary Outcome Measures
- SOFA [5 days]
improvement in SOFA Score
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Hemodynamically stable
-
Hypoxemia, i.e. p/f <150
-
Admitted to ICU within 48 hours
-
Not moribund has a life expectancy greater than 24 hours
Exclusion Criteria:
-
Age criteria
-
Pregnancy
-
Unwillingness to participate
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Istanbul University-Cerrahpaşa | Istanbul | Turkey |
Sponsors and Collaborators
- Istanbul University-Cerrahpasa
Investigators
- Study Director: Yalim Dikmen, Prof
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Olcay Dilken,
Dr.,
Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT04345887
Other Study ID Numbers:
- 10042020
First Posted:
Apr 15, 2020
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: