The main aim of the study is to estimate the potential efficacy of i.v. canrenone asadd-on therapy on maximal medical treatment versus maximal medical treatment alone intreating moderate-to-severe ARDS due to SARS-CoV-2.
Drug: Potassium Canrenoate
potassium canrenoate for 7 days in addition to maximal medical treatment
Other Name: Canrenone
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
Marco Vicenzi, MD
+390255033537
marco.vicenzi@policlinico.mi.it
Marco Vicenzi, MD, Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico