Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia.

Pneumonia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296212
• Other study ID #: GLT-07-22
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 15, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica
• Contact: Noemi Evangelisti
• Phone: 07751509595
• Email: n.evangelisti[@]foscamaspa.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Patients legally or mentally incapacitated unable to give informed consent for the participation in this trial

• Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol.

Related Conditions & MeSH terms

• Myocardial Injury
• Pneumonia
• Wounds and Injuries

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma	RM
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I	Roma	RM
Italy	Azienda Ospedaliero-Universitaria Sant'Andrea	Roma	RM
Italy	Fondazione Policlinico Universitario Campus Bio-Medico	Roma	RM
Italy	Azienda Ospedaliera Santa Maria	Terni	TR
Italy	Ospedale Ca' Foncello	Treviso	TV

Sponsors (1)

Lead Sponsor	Collaborator
Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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