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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Myocardial Injury
• Intervention / Treatment: Drug: TAD® 600 mg/4 mL powder and solvent for solution for injection; Drug: Saline solution 0.9% of sodium chloride

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Noemi Evangelisti; Phone Number: 07751509595; Email: n.evangelisti@foscamaspa.it

Study Locations

• Italy
  • PI
    • Pisa, PI, Italy, 56126
      • Recruiting
      • Azienda Ospedaliero-Universitaria Pisana
      • Contact: Massimiliano Desideri
  • RM
    • Roma, RM, Italy, 00128
      • Recruiting
      • Fondazione Policlinico Universitario Campus Bio-medico
      • Contact: Francesco Grigioni
    • Roma, RM, Italy, 00133
      • Recruiting
      • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
      • Contact: Francesco Barillà
    • Roma, RM, Italy, 00161
      • Recruiting
      • Azienda Ospedaliero-Universitaria Policlinico Umberto I
      • Contact: Pasquale Pignatelli
    • Roma, RM, Italy, 00189
      • Recruiting
      • Azienda Ospedaliero-Universitaria Sant'Andrea
      • Contact: Alberto Ricci
  • TR
    • Terni, TR, Italy, 05100
      • Recruiting
      • Azienda Ospedaliera Santa Maria
      • Contact: Giacomo Pucci
  • TV
    • Treviso, TV, Italy, 31100
      • Recruiting
      • Ospedale Ca' Foncello
      • Contact: Marcello Rattazzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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).
Placebo Comparator: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups.	Change of levels of high-sensitivity cardiac Troponin (hs-cTn) between V1 and V0 will be calculated. The non-paired T test or Mann Whitney test will be used to compare changes between groups.	7-9 days

Collaborators and Investigators

• Sponsor: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica
• Investigators: Study Director: Noemi Evangelisti, Biomedica Foscama S.p.A

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Pneumonia; Pharmaceutical Solutions
• Other Study ID Numbers: GLT-07-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No