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Spironolactone in Covid-19 Induced ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345887
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Olcay Dilken, Istanbul University-Cerrahpasa

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
Respiratory Distress Syndrome, Adult Drug: Spironolactone 100mg Drug: Placebo oral tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Spironolactone on Oxygenation in Covid-19 ARDS Patients
Estimated Study Start Date : April 21, 2020
Estimated Primary Completion Date : July 21, 2020
Estimated Study Completion Date : October 21, 2020


Arm Intervention/treatment
Active Comparator: Spironolactone
2 x 100 mg spironolactone
Drug: Spironolactone 100mg
2x100 mg spironolactone for 5 consecutive days

Placebo Comparator: Placebo
2 x 1 placebo
Drug: Placebo oral tablet
2 x1 placebo tablet




Primary Outcome Measures :
  1. p/f ratio [ Time Frame: 5 days ]
    improvement in oxygenation


Secondary Outcome Measures :
  1. SOFA [ Time Frame: 5 days ]
    improvement in SOFA Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345887


Contacts
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Contact: Olcay Dilken +905547378709 olcaydilken@gmail.com

Locations
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Turkey
Istanbul University-Cerrahpaşa
Istanbul, Turkey
Contact: Olcay Dilken    +905547378709    olcaydilken@gmail.com   
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Study Director: Yalim Dikmen Prof
Publications:
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Responsible Party: Olcay Dilken, Araş. Gör., Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT04345887    
Other Study ID Numbers: 10042020
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents