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

NCT06296212 | Recruiting Phase 3

• 1 other identifier: GLT-07-22
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TAD® 600 mg/4 mL Solution for Injection

EXPERIMENTAL

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

Saline solution of 0.9% sodium chloride

PLACEBO COMPARATOR

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

Interventions

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

TAD® 600 mg/4 mL Solution for Injection

Saline solution 0.9% of sodium chloride 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).

Saline solution of 0.9% sodium chloride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica: lead

Study Sites (7)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56126, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, 00128, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Roma, RM, 00133, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, RM, 00161, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, RM, 00189, Italy

RECRUITING

Azienda Ospedaliera Santa Maria

Terni, TR, 05100, Italy

RECRUITING

Ospedale Ca' Foncello

Treviso, TV, 31100, Italy

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

DAT protocol 1; Powders; Solvents; Solutions; Injections; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Noemi Evangelisti

  Biomedica Foscama S.p.A

  STUDY DIRECTOR

Central Study Contacts

Noemi Evangelisti

CONTACT

07751509595; n.evangelisti@foscamaspa.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 6, 2024
• Study Start: June 25, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)