Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.

Launched by BIOMEDICA FOSCAMA S.P.A. INDUSTRIA CHIMICO-FARMACEUTICA · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called TAD®, given through an IV, to see if it can help prevent heart injury in patients who have pneumonia. The goal is to find out if adding TAD® to standard pneumonia treatments is safe and effective, especially for patients who may have existing heart problems. To participate, you need to be between 18 and 80 years old and have pneumonia that requires hospitalization, along with certain heart-related health issues or a high risk for heart disease.

If you join the trial, you will receive either the TAD® treatment or a placebo (which looks the same but has no active ingredients) over five days, with two doses each day. The study is double-blind, meaning neither you nor the doctors will know which treatment you are getting. After the treatment period, there will be follow-up visits to check on your health. It’s important to note that certain medical conditions, like severe heart failure or active cancer, may prevent you from participating. If you’re interested in joining or want more information, please talk to your healthcare provider.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Patients with an age of ≥ 18 and ≤ 80 years
• • Diagnosis of CAP or HAP requiring hospitalization
• * Patients with one of the following :
• - At least one cardiovascular comorbidity:
• • Chronic atrial fibrillation
• • History of ischemic heart disease (≥ 3 months)
• • Heart failure
• • Cardiac Valvular Disease
• • Previous (≥ 6 months) episode of myocarditis or pericarditis.
• • - 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
• Medical Conditions:
• • Active malignancy
• • Severe heart failure (NYHA class III and IV)
• • End-stage renal failure (eGFR \< 30 mL/min)
• • Severe liver disease
• • History of hypersensitivity to glutathione or any excipients
• • 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.
• General Conditions:
• • 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.