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

PHASE3RecruitingINTERVENTIONAL
Enrollment

178

Participants

Timeline

Start Date

June 25, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

September 30, 2025

Conditions
PneumoniaMyocardial Injury
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).

Trial Locations (7)

31100

RECRUITING

Ospedale Ca' Foncello, Treviso

56126

RECRUITING

Azienda Ospedaliero-Universitaria Pisana, Pisa

00128

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico, Roma

00133

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma

00161

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma

00189

RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea, Roma

05100

RECRUITING

Azienda Ospedaliera Santa Maria, Terni

All Listed Sponsors
lead

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

INDUSTRY