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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
EU CTIS ID: 2023-503950-11-00
What this study is testing
TAD® used as an add-on treatment, due to the presence of the sodium salt glutathione, could be effective and safe in preventing myocardial injury in hospitalized patients with pneumonia.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with an age of ≥ 18 and ≤ 85 years
- Diagnosis of CAP or HAP requiring hospitalization
- 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.
- Provision of written informed consent as approved by the Ethics Committee (EC) by the patient or his/her legal representative.
You likely can't join if
- Active malignancy with a life expectancy < 2 years
- History of hypersensitivity to glutathione or any excipients
- Use of drugs containing sacubitril
- Use of drugs with antioxidant activity in the last 3 months
- Routine use or abuse of narcotics
- Use of invasive mechanical ventilation
See the full eligibility criteria
- Patients with an age of ≥ 18 and ≤ 85 years
- Diagnosis of CAP or HAP requiring hospitalization
- 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.
- Provision of written informed consent as approved by the Ethics Committee (EC) by the patient or his/her legal representative.
- Active malignancy with a life expectancy < 2 years
- History of hypersensitivity to glutathione or any excipients
- Use of drugs containing sacubitril
- Use of drugs with antioxidant activity in the last 3 months
- Routine use or abuse of narcotics
- Use of invasive mechanical ventilation
- Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol
- Recent (< 1 month) myocardial revascularization
- Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
- 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
- History of severe heart failure (NYHA class III and IV)
- Severe to end-stage renal failure (eGFR < 30 mL/min)
- History of severe liver disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.