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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2024-11-27

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Noemi Evangelisti · Biomedica Foscama S.p.A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06296212 on ClinicalTrials.gov