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NCT04345887 Clinical Trial

Spironolactone in Covid-19 Induced ARDS

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:
The Effect of Spironolactone on Oxygenation in Covid-19 ARDS Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04345887
Other study ID # 10042020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 5, 2020
Est. completion date July 5, 2020

Study information
Verified date October 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 5, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Spironolactone 100mg
2x100 mg spironolactone for 5 consecutive days
• Placebo oral tablet
2 x1 placebo tablet

Locations
Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Vaduganathan M, Vardeny O, Michel T, McMurray JJV, Pfeffer MA, Solomon SD. Renin-Angiotensin-Aldosterone System Inhibitors in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):1653-1659. doi: 10.1056/NEJMsr2005760. Epub 2020 Mar 30. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary p/f ratio improvement in oxygenation 5 days
Secondary SOFA improvement in SOFA Score 5 days
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