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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

7 May 2024 → ongoing

Decision date (initial)

2024-02-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

TAD® used as an add-on treatment, due to the presence of the sodium salt glutathione, could be effective and safe in preventing myocardial injury in hospitalized patients with pneumonia.

Conditions and MedDRA coding

Myocardial injury in patients affected by pneumonia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients with an age of ≥ 18 and ≤ 85 years
2. Diagnosis of CAP or HAP requiring hospitalization
3. Patients with one of the following (a or b*): a. At least one cardiovascular comorbidity: • Chronic atrial fibrillation • History of ischemic heart disease (≥ 3 months) • History of heart failure (NYHA class I e II) • Cardiac Valvular Disease • Previous (≥ 2 months) episode of myocarditis or pericarditis b. 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 40-50 years old, score ≥ 10% for patients 50-69 years old, and score ≥ 15% for patients ≥ 70 years old). * Please note that if the patient meets inclusion criterion 3(a), the CVD risk should not be calculated.
4. Provision of written informed consent as approved by the Ethics Committee (EC) by the patient or his/her legal representative.

Exclusion criteria 15

1. Active malignancy with a life expectancy < 2 years
2. Recent (< 1 month) myocardial revascularization
3. Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
4. Pregnant or breastfeeding women
5. Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
6. Participation in other investigational drug or device clinical trials within 30 days prior to study screening
7. History of severe heart failure (NYHA class III and IV)
8. Severe to end-stage renal failure (eGFR < 30 mL/min)
9. History of severe liver disease
10. History of hypersensitivity to glutathione or any excipients
11. Use of drugs containing sacubitril
12. Use of drugs with antioxidant activity in the last 3 months
13. Routine use or abuse of narcotics
14. Use of invasive mechanical ventilation
15. Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups

Secondary endpoints 6

1. Assessment at V0 versus of V2 of hs-cTn
2. Assessment at V0 versus V1 and V2 of the following parameters: • Creatine Phosphokinase-MB (CPK-MB)* • C-Reactive Protein (CRP). *CPK-MB will be evaluated only if enough patients have performed the assessment
3. Electrocardiographic assessment of heart rate and rhythm, atrio-ventricular and intraventricular conduction, ST segment/T-wave, atrial and/or ventricular hyper/hypokinetic arrhythmias, at V0 versus V1 and V2
4. Echocardiographic assessment of left ventricular Ejection Fraction (EF), left ventricular diastolic and systolic volume values, Pulmonary Artery Systolic Pressure (PASP) at V0 versus V1 and V2
5. Assessment of Brain Natriuretic Peptide (BNP) or N-Terminal pro B-type Natriuretic Peptide (NT-proBNP) at V0 versus V2
6. Qualitative and Quantitative Evaluation of all adverse drug reactions and adverse events and their frequency

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Via Morolense 87

City

Ferentino

Postcode

03013

Country

Italy

Scientific contact point

Organisation

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

Contact name

President & CEO

Public contact point

Organisation

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

Contact name

President & CEO

Third parties 1

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications