Spironolactone in Covid-19 Induced ARDS

October 21, 2021 updated by: Olcay Dilken, Istanbul University - Cerrahpasa (IUC)

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

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

Study Overview

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients admitted to the ICU due to Covid-19 ARDS requiring diuretic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spironolactone
2 x 100 mg spironolactone
2x100 mg spironolactone for 5 consecutive days
Placebo
2 x 1 placebo
2 x1 placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
p/f ratio
Time Frame: 5 days
improvement in oxygenation
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOFA
Time Frame: 5 days
improvement in SOFA Score
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yalim Dikmen, Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2020

Primary Completion (ACTUAL)

June 15, 2020

Study Completion (ACTUAL)

July 5, 2020

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (ACTUAL)

April 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Distress Syndrome, Adult

Clinical Trials on Spironolactone 100mg

Subscribe