Impact of the intravenous administration of the diuretic canrenone together with standard therapy on clinical outcome in patients suffering for moderate-to-severe respiratory failure caused by COVID-19 infection.

Phase 1

Active, not recruiting

• Conditions: SARS-CoV2 infection; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-001360-20-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-17
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

- Invasive mechanical ventilation
- I.v. hydratation with Darrow’s solution or half-strenght 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
- Hyponatremia
- Anuria
- Familial history of porphyria
- Pregnancy or breastfeeding
- known or suspected hypersensitivity to canrenone
- Inclusion in any other pharmacological clinical trials

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 1)investigate whether i.v. canrenone can modulate the COVID-19 progression;<br>2)evaluate the safety profile of canrenone administration in COVID-19 patients;<br>3)preliminary screening of potential new biomarkers, prognostic for clinical outcome and/or predictive of efficacy and safety of canrenone;<br>4)explore the role of RAAS on SARS-CoV-2 infection.;Primary end point(s): In-hospital death. This implies that patients discharged to a long-term care facility will be classified as discharged alive”;Timepoint(s) of evaluation of this end point: Primary endpoint will be assessed at the event (discharge or death).