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
  • Drug: Spironolactone 100mg
  • Drug: Placebo oral tablet

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

  1. p/f ratio [5 days]

    improvement in oxygenation

Secondary Outcome Measures

  1. 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:

Study Results

No Results Posted as of Oct 28, 2021