Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT04977960
Eligibility Criteria:
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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04977960
Study Brief:
Protocol Section:
NCT04977960