Efficacy of Canrenone as add-on Treatment in Moderate to Severe ARDS in COVID-19

MINECRAFT Study: MINEralcorticoid Receptor Antagonism With CanRenone As eFfective Treatment in Moderate to Severe ARDS in COVID-19, a Phase 2 Clinical Trial.

The main aim of the study is to estimate the potential efficacy of i.v. canrenone as add-on therapy on maximal medical treatment versus maximal medical treatment alone in treating moderate-to-severe ARDS due to SARS-CoV-2.

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