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| Column | Value |
|---|---|
| Trial registration number | NCT04977960 |
|
Full text link
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
marco.vicenzi@policlinico.mi.it |
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Registration date
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
2021-07-27 |
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Recruitment status
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
inclusion criteria: - age 18 - 80 y.o. since over eighties are very fragile patients, a lot of confounding unpredictable events may interfere with the trial analyses; thus, these patients will be excluded from this exploratory proof-of-concept trial; - covid-19 diagnosis through swab within 14 days from the beginning of symptoms - hospitalization for moderate to severe ards (as determined by pao2/fio2 ≤300 mmhg at admission) - serum concentration of potassium ≤4.5 meq/l - consent to participate |
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Exclusion criteria
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
- invasive mechanical ventilation - i.v. hydratation with darrow's solution or half-strength darrow's solution underway - acute cardiovascular event (acute myocardial infarction, acute ischaemic stroke) - current malignant disease - creatinine >1.8 mg/dl (for women) and >2.0 mg/dl (for men) or glomerular filtration rate <50 ml/mm - systolic blood pressure <110 mmhg and/or diastolic blood pressure <60 mmhg - known or suspected hypersensitivity to canrenone - hyponatremia - anuria - familial history of porphyria - pregnancy and breastfeeding - known or suspected hypersensitivity to canrenone - inclusion in any other pharmacological clinical trials |
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Number of arms
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
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Inclusion age min
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
80 |
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Countries
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
180 |
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primary outcome
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
in-hospital death |
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Notes
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 250, "treatment_name": "Canrenoate potassium", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |