Multicenter, randomized, double-blind, Phase III study of intravenous TAD® 600 mg/4 ml solution for injection to evaluate efficacy and safety in preventing myocardial injury in patients with pneumonia

Phase 1

Recruiting

• Conditions: Myocardial injury in patients affected by pneumonia; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-503950-11-00
• Lead Sponsor: Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Patients with an age of = 18 and = 80 years, Diagnosis of CAP or HAP requiring hospitalization, Patients with one of the following (a or b): a. At least one cardiovascular comorbidity: • Hypertension • Permanent atrial fibrillation • History of ischemic heart disease • Heart failure • Diabetes • Cardiac Valvular Disease • Previous (= 6 months) episode of myocarditis or pericarditis • Chronic kidney disease (eGFR = 60 mL/min and = 30 mL/min) 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 < 50 years old, score = 10% for patients 50-69 years old, and score = 15% for patients = 70 years old), Provision of written informed consent as approved by the Ethics Committee (EC)

Exclusion Criteria

Active malignancy, Pregnant or breastfeeding women, Women of child-bearing potential not using at least one effective contraceptive method for the entire trial, Participation in other investigational drug or device clinical trials within 30 days prior to study screening, Patients legally or mentally incapacitated unable to give informed consent for the participation in this trial, Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol, End-stage renal failure (eGFR < 30 mL/min), Severe liver disease, History of hypersensitivity to glutathione, Use of drugs containing sacubitril, Use of drugs with antioxidant activity in the last 3 months, Use of narcotics, Use of invasive mechanical ventilation, Recent (< 3 months) ACS (STEMI, NSTEMI, UA), myocardial revascularization, myocarditis, acute pericarditis episodes

Study & Design

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