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Study on Pirfenidone for Preventing Lung Fibrosis in Patients with Acute Respiratory Distress Syndrome (ARDS)

Fast replyRegistered drugNo placebo
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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 a condition known as Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious lung condition that causes difficulty in breathing. The study is testing a medication called Pirfenidone, which is being evaluated for its potential to prevent lung scarring in patients with ARDS. The trial will compare the effects of Pirfenidone to a placebo, which is a substance with no active medication.

The main goal of the study is to see if Pirfenidone can increase the number of days patients can breathe without the help of a ventilator by day 28. Participants in the study will receive either Pirfenidone or a placebo, and their progress will be monitored over a period of 28 days. The study will also look at other outcomes, such as the number of days patients spend outside of the intensive care unit (ICU), improvements in lung function, and overall quality of life.

Throughout the study, various tests and assessments will be conducted to gather information on the effectiveness and safety of Pirfenidone. These include checking for changes in lung tissue using high-resolution computed tomography (CT) scans, measuring heart function with echocardiography, and evaluating physical performance through a six-minute walk test. The study aims to provide valuable insights into the potential benefits of Pirfenidone for patients with ARDS.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including having moderate or severe acute respiratory distress syndrome (ARDS) as defined by the Berlin definition.

    Consent must be provided by the patient, a legal representative, or as indicated by an ethical committee.

  2. Step 2

    Treatment administration

    The treatment involves the administration of pirfenidone, which is provided in the form of 267 mg film-coated tablets known as Esbriet.

    The medication is taken orally, or through a nasogastric tube or percutaneous endoscopic gastrostomy tube, depending on the patient's condition.

    The treatment aims to increase the number of ventilator-free days by day 28 compared to a placebo group.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, various health parameters are monitored, including the number of intensive care unit (ICU)-free days and the cumulative SOFA-free score at day 28.

    Additional assessments include the length of hospital stay, changes in lung condition as seen on high-resolution CT scans, and overall mortality at ICU or hospital discharge.

  4. Step 4

    Follow-up evaluations

    Upon discharge from the hospital, pulmonary function tests such as spirometry are conducted to evaluate lung function.

    Further evaluations include a six-minute walk test conducted between 6 to 12 months after discharge to assess physical endurance.

  5. Step 5

    Quality of life assessment

    Quality of life is measured using the EQ-5D Health Questionnaire and the SF-36 questionnaire to understand the impact of the treatment on daily living.

    Heart function is also assessed through echocardiography at ICU discharge to check for any dysfunction.

  6. Step 6

    Adverse events and additional therapies

    The trial monitors any adverse events that may occur during the treatment period.

    The use of additional therapies for severe low oxygen levels is also documented.

Who can join the trial?

7 criteria

  • The patient must have **Acute Respiratory Distress Syndrome (ARDS)**, which is a serious lung condition. It should be either moderate or severe, as defined by the Berlin definition.
  • The patient must have an **inflammatory ARDS phenotype**, which means their ARDS is related to inflammation. This can be shown by at least one of the following:
    • High levels of inflammatory markers in the blood, such as **IL-6** greater than 80 pg/ml or **PCR** greater than 250 mg/l.
    • Dependence on **vasopressors**, which are medications that help raise blood pressure, for at least one hour.
    • Low levels of **serum bicarbonate** (less than 18 mmol/l) or high levels of **serum lactate** (greater than 4 mmol/l).
    • The patient or their legal representative must give **informed consent**, which means they agree to participate in the study after understanding what it involves.
    • The study is open to both **male and female** participants.
    • The study includes participants from a **vulnerable population**, which means they might need special protection or consideration.

Who cannot join the trial?

10 criteria

  • Patients who have a known allergy or sensitivity to the study medication, which is called **Pirfenidone**.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe liver disease, which means the liver is not working properly.
  • Patients with a history of severe kidney disease, which means the kidneys are not working properly.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of certain heart conditions, such as a recent heart attack.
  • Patients who have a history of certain lung conditions, such as severe asthma.
  • Patients who have a history of certain blood disorders, which affect how blood cells work.
  • Patients who have a history of certain immune system disorders, which affect how the body fights infections.
  • Patients who have a history of certain mental health conditions, such as severe depression.
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Investigated drugs

Pirfenidone is a medication being tested in this clinical trial to see if it can help prevent lung fibrosis in patients with Acute Respiratory Distress Syndrome (ARDS). The goal is to see if patients taking Pirfenidone have more days without needing a ventilator within the first 28 days compared to those who do not receive the medication.

What is already known about the treatment

Pirfenidone – Pirfenidone is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential to prevent fibrosis in patients with Acute Respiratory Distress Syndrome (ARDS). The main therapeutic indication for Pirfenidone is to increase the number of ventilator-free days in patients with ARDS. At the molecular level, Pirfenidone works by inhibiting the production of certain proteins that lead to inflammation and scarring in the lungs. It is classified as an antifibrotic agent, which means it helps reduce the formation of fibrous tissue.

Investigated diseases

Acute Respiratory Distress Syndrome (ARDS) – ARDS is a severe lung condition that occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. This fluid prevents the lungs from filling with enough air, which means less oxygen reaches the bloodstream. As a result, organs may not get the oxygen they need to function properly. ARDS typically develops in people who are already critically ill or who have significant injuries. The condition progresses rapidly, often within a few hours to a few days after the initial injury or illness. It can lead to severe shortness of breath and requires immediate medical attention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514355-16-01Protocol codeGR-2019-12371063Estimated enrolment130 patientsSponsorOspedale San Raffaele S.r.l.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).