Phase
Condition
Pneumonia
Myocardial Ischemia
Treatment
TAD® 600 mg/4 mL powder and solvent for solution for injection
Saline solution 0.9% of sodium chloride
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Connect with a study center
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI 56126
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, RM 00133
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, RM 00161
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, RM 00189
ItalyActive - Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, RM 00128
ItalyActive - Recruiting
Azienda Ospedaliera Santa Maria
Terni, TR 05100
ItalyActive - Recruiting
Ospedale Ca' Foncello
Treviso, TV 31100
ItalyActive - Recruiting
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