Glutathione for Myocardial injury | Pneumonia

Inclusion criteria

• {"criterion_text":"- Patients with an age of ≥ 18 and ≤ 85 years"}
• {"criterion_text":"- Diagnosis of CAP or HAP requiring hospitalization"}
• {"criterion_text":"- Patients with one of the following (a or b*): a. At least one cardiovascular comorbidity: • Chronic atrial fibrillation • History of ischemic heart disease (≥ 3 months) • History of heart failure (NYHA class I e II) • Cardiac Valvular Disease • Previous (≥ 2 months) episode of myocarditis or pericarditis b. Very high risk of developing cardiovascular diseases according to the SCORE2 and SCORE2-OP risk models for moderate risk European regions (score ≥ 7.5% for patients 40-50 years old, score ≥ 10% for patients 50-69 years old, and score ≥ 15% for patients ≥ 70 years old). * Please note that if the patient meets inclusion criterion 3(a), the CVD risk should not be calculated."}
• {"criterion_text":"- Provision of written informed consent as approved by the Ethics Committee (EC) by the patient or his/her legal representative."}

Exclusion criteria

• {"criterion_text":"- Active malignancy with a life expectancy < 2 years"}
• {"criterion_text":"- History of hypersensitivity to glutathione or any excipients"}
• {"criterion_text":"- Use of drugs containing sacubitril"}
• {"criterion_text":"- Use of drugs with antioxidant activity in the last 3 months"}
• {"criterion_text":"- Routine use or abuse of narcotics"}
• {"criterion_text":"- Use of invasive mechanical ventilation"}
• {"criterion_text":"- Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol"}
• {"criterion_text":"- Recent (< 1 month) myocardial revascularization"}
• {"criterion_text":"- Women of child-bearing potential not using at least one effective contraceptive method for the entire trial"}
• {"criterion_text":"- Pregnant or breastfeeding women"}
• {"criterion_text":"- Women of child-bearing potential not using at least one effective contraceptive method for the entire trial"}
• {"criterion_text":"- Participation in other investigational drug or device clinical trials within 30 days prior to study screening"}
• {"criterion_text":"- History of severe heart failure (NYHA class III and IV)"}
• {"criterion_text":"- Severe to end-stage renal failure (eGFR < 30 mL/min)"}
• {"criterion_text":"- History of severe liver disease"}

Primary endpoints

• {"endpoint_text":"- Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups","definition_or_measurement_approach":"Change in levels of high-sensitivity cardiac Troponin (hs-cTn) measured at visit V1 compared to baseline V0 in the two groups."}

Secondary endpoints

• {"endpoint_text":"- Assessment at V0 versus of V2 of hs-cTn","definition_or_measurement_approach":"Comparison of high-sensitivity cardiac Troponin (hs-cTn) levels at V2 versus baseline V0."}
• {"endpoint_text":"- Assessment at V0 versus V1 and V2 of the following parameters: • Creatine Phosphokinase-MB (CPK-MB)* • C-Reactive Protein (CRP). *CPK-MB will be evaluated only if enough patients have performed the assessment","definition_or_measurement_approach":"Comparisons of CPK-MB (if sufficient data) and C-Reactive Protein (CRP) at V1 and V2 versus baseline V0."}
• {"endpoint_text":"- Electrocardiographic assessment of heart rate and rhythm, atrio-ventricular and intraventricular conduction, ST segment/T-wave, atrial and/or ventricular hyper/hypokinetic arrhythmias, at V0 versus V1 and V2","definition_or_measurement_approach":"ECG assessments comparing specified ECG parameters (heart rate, rhythm, conduction, ST/T changes, arrhythmias) at V1 and V2 versus baseline V0."}
• {"endpoint_text":"- Echocardiographic assessment of left ventricular Ejection Fraction (EF), left ventricular diastolic and systolic volume values, Pulmonary Artery Systolic Pressure (PASP) at V0 versus V1 and V2","definition_or_measurement_approach":"Echocardiographic measurements of LVEF, LV volumes, and PASP compared at V1 and V2 versus baseline V0."}
• {"endpoint_text":"- Assessment of Brain Natriuretic Peptide (BNP) or N-Terminal pro B-type Natriuretic Peptide (NT-proBNP) at V0 versus V2","definition_or_measurement_approach":"Comparison of BNP or NT-proBNP biomarker levels at V2 versus baseline V0."}
• {"endpoint_text":"- Qualitative and Quantitative Evaluation of all adverse drug reactions and adverse events and their frequency","definition_or_measurement_approach":"Collection and analysis of adverse drug reactions and adverse events, qualitatively and quantitatively, with frequency counts."}

Italy

Earliest CTIS Part Ii Submission Date

14-02-2024

Latest Decision Or Authorization Date

25-06-2025

Processing Time Days

497

Number Of Sites

7

Number Of Participants

178

Primary sponsor

Full Name

Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Crolife S.r.l.","duties_or_roles":"1;10;11;12;13;14;2;3;5;6;7;9","organisation_type":"Pharmaceutical company"}