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Trial - NCT04912011


Column Value
Trial registration number NCT04912011
Full text link
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04912011

First author
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Katarzyna L Kotfis, MD, PhD

Contact
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

katarzyna.kotfis@pum.edu.pl

Registration date
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-06-03

Recruitment status
Last imported at : June 4, 2023, 4 a.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 10, 2021, 12:33 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: 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 criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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.

Number of arms
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Pomeranian Medical University Szczecin

Inclusion age min
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

90

Countries
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Poland

Type of patients
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

50

primary outcome
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Mechanical ventilation;Passive oxygen therapy

Notes
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : June 10, 2021, 12:33 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 250, "treatment_name": "Canrenoate potassium", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]