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.

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-06-01
• Completion: 2025-09-30
• First posted: 2024-03-06
• Last updated: 2024-11-27

Locations

7 sites across 1 country: Italy