NCT04345887

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

May 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2020

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

April 10, 2020

Last Update Submit

October 21, 2021

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (1)

  • p/f ratio

    improvement in oxygenation

    5 days

Secondary Outcomes (1)

  • SOFA

    5 days

Study Arms (2)

Spironolactone

2 x 100 mg spironolactone

Drug: Spironolactone 100mg

Placebo

2 x 1 placebo

Drug: Placebo oral tablet

Interventions

Spironolactone 100mgDRUG

2x100 mg spironolactone for 5 consecutive days

Spironolactone
Placebo oral tabletDRUG

2 x1 placebo tablet

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Hemodynamically stable
  • Hypoxemia, i.e. p/f \<150
  • Admitted to ICU within 48 hours
  • Not moribund has a life expectancy greater than 24 hours

You may not qualify if:

  • Age criteria
  • Pregnancy
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 32227760BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Canrenoic Acid

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yalim Dikmen

    Prof

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 15, 2020

Study Start

May 5, 2020

Primary Completion

June 15, 2020

Study Completion

July 5, 2020

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)