SARS-CoV2 infection MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: LUVION - 200 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE USO ENDOVENOSO 6 FLACONI LIOFILIZZATI + 6 FIALE
Product Name: Luvion
Product Code: [Canrenoato potassico]
Pharmaceutical F
Sponsors
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 2) evaluate the safety profile of canrenone administration in COVID-19 patients; 3) preliminary screening of potential new biomarkers, prognostic for clinical outcome and/or predictive of efficacy and safety of canrenone; 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 48 hours/7 days after randomization and at the event (need for invasive mechanical ventilation, duration of hospitalization, safety endpoints);Secondary end point(s): • Need of invasive mechanical ventilation throughout hospitalization; • Change in SOFA score from randomization to 7 days after randomization; • Changes in hemodynamic and respiratory parameters (Heart Rate, Blood Pressure, PaO2/FiO2, alveolar-arterial gradient (deltaA-a), inflammatory status (CRP levels, IL-6, Ddimer and Ferritin) at 48 hours and 168 hours (7th day) from randomization; • Changes in features of pulmonary interstitial disease measured by chest X-Ray at 7 days after randomization in both groups; • Changes in [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids at randomization (T1), and after 48 hrs (T2) and 7 days (T3) and comparison between the two groups of the study; • Correlation between levels of [K+]hematic, renin, AngII, Ang1-7, Ang1-9, aldosterone and structurally related steroids, at basal level (randomization) and clinical outcomes (in-hospital death, need of invasive mechanical ventilation, SOFA score); • Duration of hospitalization for alive patients (from randomization to discharge, T4); • Safety endpoints: - Drug intolerance measured as number of AR and SAR as defined in the “Harm” paragraph; - Number of hypotensive events defined as systolic blood pressure constantly 5.1 mEq/L; - Number of Renal failures defined as eGFR <30 ml/min. | — |
Countries
Italy
Contacts
Public ContactUOC CARDIOLOGIA
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Outcome results
None listed