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

NCT ID: NCT06296212

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-09-30

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.

Conditions

Pneumonia; Myocardial Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TAD® 600 mg/4 mL Solution for Injection

TAD® 600 mg/4 mL powder and solvent for solution for injection, 1 vial powder (glutathione sodium salt 646 mg) + 1 solvent ampoule (4 mL water for injection) reconstituted solution in 50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes).

Group Type: EXPERIMENTAL

TAD® 600 mg/4 mL powder and solvent for solution for injection

Intervention Type: DRUG

TAD® 600 mg/4 mL powder and solvent for solution for injection, 1 vial powder (glutathione sodium salt 646 mg) + 1 solvent ampoule (4 mL water for injection) reconstituted solution in 50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes).

Saline solution of 0.9% sodium chloride

Placebo (50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes).

Group Type: PLACEBO_COMPARATOR

Saline solution 0.9% of sodium chloride

Intervention Type: DRUG

Placebo (50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes).

Interventions

TAD® 600 mg/4 mL powder and solvent for solution for injection

TAD® 600 mg/4 mL powder and solvent for solution for injection, 1 vial powder (glutathione sodium salt 646 mg) + 1 solvent ampoule (4 mL water for injection) reconstituted solution in 50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes).

Intervention Type: DRUG

Saline solution 0.9% of sodium chloride

Placebo (50 mL of 0.9% sodium chloride solution) 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). Doses will be administered at the same time of the day (every 24 hours ± 30 minutes).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noemi Evangelisti

Role: STUDY_DIRECTOR

Biomedica Foscama S.p.A

Locations

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Site Status: RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Roma, RM, Italy

Site Status: RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, RM, Italy

Site Status: RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, RM, Italy

Site Status: RECRUITING

Azienda Ospedaliera Santa Maria

Terni, TR, Italy

Site Status: RECRUITING

Ospedale Ca' Foncello

Treviso, TV, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Noemi Evangelisti

Role: CONTACT

n.evangelisti@foscamaspa.it

07751509595

Facility Contacts

Massimiliano Desideri

Role: primary

Francesco Grigioni

Role: primary

Francesco Barillà

Role: primary

Pasquale Pignatelli

Role: primary

Alberto Ricci

Role: primary

Giacomo Pucci

Role: primary

Marcello Rattazzi

Role: primary

Other Identifiers

GLT-07-22

Identifier Type: -

Identifier Source: org_study_id