Clinical trial NCT06296212: Study of Intravenous TAD® 600 Mg/4 ML Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients with Pneumonia.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pneumonia
Myocardial Injury
Lead sponsor: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia.

The main question it aims to answer is:

• could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia?

Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment.

Eligible patients who meet the study inclusion criteria and complete the required Screening \& Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI \& Patient blinded.

TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered:

* intravenously (with an infusion rate of 10 mL/min)
* 2 times a day (with a dosing interval of 8 hours ± 30 minutes)
* for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5)
* patients will then be required to undergo five Follow-up Visits.


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.

Primary outcomes:
measure: Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups.
timeFrame: 7-9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
state: RM
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: RM
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I
state: RM
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Andrea
state: RM
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
state: TR
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello
state: TV
Study officials:
affiliation: Biomedica Foscama S.p.A
name: Noemi Evangelisti
role: STUDY_DIRECTOR
References: