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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; University of Milan
• Treatments: Canrenoic Acid; Canrenone

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