Spironolactone in Covid-19 Induced ARDS | NCT04345887

Studies
Spironolactone in Covid-19 Induced ARDS

NCT04345887

Sponsor

Istanbul University - Cerrahpasa

Status

Completed

Last Update Posted

Oct 28, 2021Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Respiratory Distress Syndrome, Adult

Interventions

Spironolactone 100mg
Placebo oral tablet

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2020Actual

Primary Completion Date

Jun 15, 2020Actual

Completion Date

Jul 5, 2020Actual

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2021

Last Update Posted Date

Oct 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spironolactone		2 x 100 mg spironolactone	Drug: Spironolactone 100mg
Placebo		2 x 1 placebo	Drug: Placebo oral tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spironolactone 100mg	Drug	2x100 mg spironolactone for 5 consecutive days	Spironolactone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
SOFA	improvement in SOFA Score	5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yalim Dikmen	Prof	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul University-Cerrahpaşa		Istanbul			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32227760	Background	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.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds