Status:
UNKNOWN
Mineralocorticoid Receptor Antagonist and Pulmonary Fibrosis in COVID-19.
Lead Sponsor:
Pomeranian Medical University Szczecin
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
In December 2019 SARS-CoV-2 virus appeared in the world, mainly appearing as an acute infection of the lower respiratory tract. In March 2020, the World Health Organization (WHO) announced a pandemic ...
Eligibility Criteria
Inclusion
- Patients of both sexes, 18-90 years of age.
- Patient requiring oxygen therapy, SpO2 \<94%.
- Confirmed COVID-19 infection.
- At least one risk factor for increased mortality in the course of COVID-19: currently published in the literature e.g. smoking, hypertension, diabetes, cardiovascular disease.
- Documented informed consent according to ICH-GCP and national regulations.
Exclusion
- Chronic bronchitis, emphysema, interstitial lung disease, or other history of lung disease.
- Contraindications to the use of spironolactone.
- Hypersensitivity to spironolactone or any of the excipients.
- Pregnant patients (pregnancy test will be performed in every patient of reproductive age) and during lactation.
- Patients with mental illness or dementia who are unable to give informed consent to the examination.
- ARDS caused by another viral infection (SARS-CoV-2 negative).
- ARDS from other causes/trauma.
- Ionic disorders: hyperkalemia, hyponatraemia.
- Adrenal crisis.
- Acute and chronic renal failure, creatinine clearance less than 30 ml/min.
- Anuria.
- Porphyria.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04912011
Start Date
January 1 2021
End Date
December 31 2021
Last Update
June 8 2021
Active Locations (1)
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1
Pomeranian Medical University
Szczecin, Poland, 70-111