- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345887
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
Status
Completed
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Spironolactone
Other Study ID Numbers
- 10042020
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.
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