178
Participants
Start Date
June 25, 2024
Primary Completion Date
June 30, 2025
Study Completion Date
September 30, 2025
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).
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).
RECRUITING
Ospedale Ca' Foncello, Treviso
RECRUITING
Azienda Ospedaliero-Universitaria Pisana, Pisa
RECRUITING
Fondazione Policlinico Universitario Campus Bio-Medico, Roma
RECRUITING
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma
RECRUITING
Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma
RECRUITING
Azienda Ospedaliero-Universitaria Sant'Andrea, Roma
RECRUITING
Azienda Ospedaliera Santa Maria, Terni
Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica
INDUSTRY