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

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.

Not yet recruiting
COVID-19 Acute Respiratory Distress Syndrome

Drug: Potassium Canrenoate
potassium canrenoate for 7 days in addition to maximal medical treatment
Experimental Group
Other Name: Canrenone

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 80 Years
Contacts

Marco Vicenzi, MD
+390255033537
marco.vicenzi@policlinico.mi.it

Marco Vicenzi, MD
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
University of Milan
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT Number
Keywords
Covid-19
potassium canrenoate
MeSH Terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Canrenone
Canrenoic Acid