Using TAD® to prevent heart injury in pneumonia patients
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.
This study is testing if a new treatment called TAD® can help prevent heart injury in pneumonia patients who are hospitalized.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica Industry-sponsored |
| Locations | 7 sites (Pisa, PI and 6 other locations) |
| Trial ID | NCT06296212 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial evaluates the efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury among hospitalized patients diagnosed with pneumonia. The study aims to determine if TAD®, which contains sodium salt glutathione, can serve as an effective add-on treatment to standard therapy. Eligible patients will be randomized in a double-blind manner to receive either the TAD® treatment or a placebo, allowing for a rigorous assessment of its impact on heart health. The trial will include patients aged 18 to 80 with specific cardiovascular comorbidities or high risk for cardiovascular diseases.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 18 to 80 with pneumonia and at least one cardiovascular comorbidity or a high risk of developing cardiovascular diseases.
Not a fit: Patients with active malignancy, severe heart failure, end-stage renal failure, or severe liver disease are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of myocardial injury in patients suffering from pneumonia.
How similar studies have performed: Other studies have explored similar approaches, but the specific use of TAD® in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pisa, PI and 6 other locations
- Azienda Ospedaliero-Universitaria Pisana — Pisa, Pi, Italy (Recruiting)
- Fondazione Policlinico Universitario Campus Bio-Medico — Roma, Rm, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Roma, Rm, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Policlinico Umberto I — Roma, Rm, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Sant'Andrea — Roma, Rm, Italy (Recruiting)
- Azienda Ospedaliera Santa Maria — Terni, Tr, Italy (Recruiting)
- Ospedale Ca' Foncello — Treviso, Tv, Italy (Recruiting)
Study contacts
- Study coordinator: Noemi Evangelisti
- Email: n.evangelisti@foscamaspa.it
- Phone: 07751509595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.