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Study on Glutathione and Sodium Chloride for Preventing Heart Injury in Pneumonia Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of myocardial injury, which is a type of heart damage, in patients who have pneumonia. The study will use a treatment called TAD® 600 mg/4 ml solution for injection, which contains the active substance glutathione. Glutathione is a chemical that may help protect the heart from damage. The trial will also involve the use of sodium chloride solution, which is commonly used in medical settings as a solvent or diluting agent.

The purpose of the study is to evaluate the effectiveness and safety of TAD® as an additional treatment to prevent heart damage in patients hospitalized with pneumonia. Participants in the study will receive the treatment intravenously, meaning it will be administered directly into a vein. The study will compare the effects of TAD® with those of a placebo to determine its potential benefits. The trial will be conducted over a period of several days, during which participants will be closely monitored for any changes in their heart health.

Throughout the study, various health assessments will be conducted to monitor the participants' heart function and overall well-being. These assessments will include measuring levels of certain proteins in the blood that indicate heart health, as well as performing tests like electrocardiograms (ECGs) to check heart rhythm and function. The study aims to provide valuable information on whether TAD® can be a safe and effective option for preventing heart damage in patients with pneumonia.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age between 18 and 80 years, diagnosis of community-acquired or hospital-acquired pneumonia requiring hospitalization, and certain cardiovascular conditions or risks.

    Written informed consent is required before participation.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes evaluating levels of high-sensitivity cardiac Troponin (hs-cTn), which is a protein released when the heart muscle is damaged.

    Other assessments include electrocardiographic and echocardiographic evaluations to check heart function and structure.

  3. Step 3

    Treatment administration

    The treatment involves the administration of TAD® 600 mg/4 ml solution for injection, which contains glutathione, a substance that may help prevent heart injury.

    The medication is given intravenously, meaning it is delivered directly into a vein.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments are conducted to monitor changes in hs-cTn levels and other heart-related parameters.

    These assessments help evaluate the effectiveness and safety of the treatment in preventing heart injury.

  5. Step 5

    Final evaluation

    At the end of the study, a final evaluation is performed to compare the initial and ongoing assessment results.

    This includes a comprehensive review of any adverse reactions or events experienced during the trial.

Who can join the trial?

14 criteria

  • Patients must be between the ages of 18 and 80 years old.
  • Patients must have a diagnosis of pneumonia that requires them to be in the hospital. Pneumonia is an infection that inflames the air sacs in one or both lungs.
  • Patients must have at least one of the following heart-related conditions or risks:
    • Hypertension: This means having high blood pressure.
    • Permanent atrial fibrillation: A condition where the heart beats irregularly and often rapidly.
    • History of ischemic heart disease: This means having had problems with blood flow to the heart.
    • Heart failure: A condition where the heart doesn't pump blood as well as it should.
    • Diabetes: A disease that affects how the body uses blood sugar.
    • Cardiac Valvular Disease: Problems with one or more of the heart valves.
    • Previous episode of myocarditis or pericarditis: These are conditions where the heart muscle or the lining around the heart is inflamed, and it must have occurred at least 6 months ago.
    • Chronic kidney disease: A long-term condition where the kidneys do not work as well as they should, with a specific measure of kidney function between 30 and 60.
    • Patients can also participate if they are at a very high risk of developing heart-related diseases based on specific risk models. These models use scores to estimate the risk:
      • For patients under 50 years old, the score must be 7.5% or higher.
      • For patients aged 50 to 69 years old, the score must be 10% or higher.
      • For patients 70 years old or older, the score must be 15% or higher.
      • Patients must agree to participate by signing a written consent form that has been approved by an Ethics Committee. This means they understand the study and agree to be part of it.

Who cannot join the trial?

5 criteria

  • Patients who are not affected by pneumonia cannot participate.
  • Patients who do not have a risk of myocardial injury cannot participate. Myocardial injury refers to damage to the heart muscle.
  • Patients who are not hospitalized cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like pregnant women, children, or people with certain disabilities.
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Investigated drugs

TAD® is a medication being studied for its potential to prevent heart damage in patients with pneumonia. It is given as an injection and contains a substance called sodium salt glutathione, which may help protect the heart. The study aims to determine if TAD® is both effective and safe for this purpose.

What is already known about the treatment

TAD® – This medication is administered intravenously as a 600 mg/4 ml solution for injection. It is currently being studied in a Phase III clinical trial to assess its efficacy and safety in preventing myocardial injury in patients with pneumonia. The main therapeutic indication is to serve as an add-on treatment for myocardial injury prevention in these patients. TAD® contains sodium salt glutathione, which is believed to work by reducing oxidative stress at the molecular level, potentially protecting heart tissue. It is classified pharmacologically as an antioxidant.

Investigated diseases

Myocardial injury in patients affected by pneumonia – This condition occurs when the heart muscle is damaged in individuals who are suffering from pneumonia. Pneumonia is an infection that inflames the air sacs in one or both lungs, which can fill with fluid or pus. The inflammation and infection can lead to stress on the heart, potentially causing injury to the heart muscle. This injury is often indicated by elevated levels of cardiac biomarkers such as high-sensitivity cardiac Troponin (hs-cTn). The progression of myocardial injury can vary, but it generally involves changes in heart function and structure, which may be monitored through various cardiac assessments. These assessments can include electrocardiograms, echocardiograms, and measurements of specific proteins in the blood that indicate heart stress or damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503950-11-00Protocol codeGLT-07-22Estimated enrolment178 patientsSponsorBiomedica Foscama Industria Chimico-Farmaceutica S.p.A.

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