Spironolactone in Covid-19 Induced ARDS

NCT ID: NCT04345887

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-05

Study Completion Date

2020-07-05

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Distress Syndrome, Adult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spironolactone

2 x 100 mg spironolactone

Spironolactone 100mg

Intervention Type DRUG

2x100 mg spironolactone for 5 consecutive days

Placebo

2 x 1 placebo

Placebo oral tablet

Intervention Type DRUG

2 x1 placebo tablet

Interventions

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Spironolactone 100mg

2x100 mg spironolactone for 5 consecutive days

Intervention Type DRUG

Placebo oral tablet

2 x1 placebo tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Olcay Dilken

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yalim Dikmen

Role: STUDY_DIRECTOR

Prof

Locations

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Istanbul University-Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 32227760 (View on PubMed)

Other Identifiers

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10042020

Identifier Type: -

Identifier Source: org_study_id