Respiratory Distress Syndrome, AdultNCT04345887
Spironolactone in Covid-19 Induced ARDS
An observational study of Respiratory Distress Syndrome, Adult, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Spironolactone 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2020to 5 Jul 2020
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted to the ICU due to Covid-19 ARDS requiring diuretic
Who may be able to join
- Hemodynamically stable
- Hypoxemia, i.e. p/f <150
- Admitted to ICU within 48 hours
- Not moribund has a life expectancy greater than 24 hours
Who cannot join
- Age criteria
- Pregnancy
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Spironolactone 100mg, Placebo oral tablet
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 100mgDrug
2x100 mg spironolactone for 5 consecutive days
Placebo oral tabletDrug
2 x1 placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | 2 x 100 mg spironolactone Receives: Drug: Spironolactone 100mg | |
| Placebo | 2 x 1 placebo Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
p/f ratio
improvement in oxygenation
Measured: 5 days
Secondary outcomes (1)
SOFA
improvement in SOFA Score
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start5 May 2020
- Primary completion15 Jun 2020
- Study completion5 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Dilken, Istanbul University - Cerrahpasa
- Investigators
- Yalim Dikmen, Study director, Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345887
- Sponsor's protocol ID
- 10042020
- Status last verified
- Oct 2021
- First submitted
- 10 Apr 2020
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32227760
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spironolactone on Oxygenation in Covid-19 ARDS Patients
- ClinicalTrials.gov ID
- NCT04345887
- Acronym / sponsor ID
- 10042020
- Conditions
- Respiratory Distress Syndrome, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 5 Jul 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | – | Drug: Spironolactone 100mg2 x 100 mg spironolactone |
| Placebo | – | Drug: Placebo oral tablet2 x 1 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to the ICU due to Covid-19 ARDS requiring diuretic
Key inclusion criteria (4 listed)
- Hemodynamically stable
- Hypoxemia, i.e. p/f <150
- Admitted to ICU within 48 hours
- Not moribund has a life expectancy greater than 24 hours
Key exclusion criteria (3 listed)
- Age criteria
- Pregnancy
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone 100mg2x100 mg spironolactone for 5 consecutive days | Drug | Spironolactone |
| Placebo oral tablet2 x1 placebo tablet | Drug | Placebo |
Primary outcome
p/f ratio
Time frame: 5 days
improvement in oxygenation
1 secondary outcome
SOFA
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 32227760Vaduganathan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yalim Dikmen study director
Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
p/f ratio (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.