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Study on Anakinra for Patients with Non-COVID-19 Related Acute Respiratory Distress Syndrome (ARDS)

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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 effectiveness and safety of a medication called anakinra in treating a condition known as Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition where the lungs cannot provide enough oxygen to the body's organs. This study is specifically looking at cases of ARDS that are not related to COVID-19.

The purpose of the study is to evaluate how many days patients can breathe without the help of a ventilator. Participants in the study will receive Kineret, which is the brand name for anakinra, administered as a solution for injection. The study will compare the effects of this treatment on patients with ARDS to see if it can help improve their breathing and reduce the need for mechanical ventilation.

Throughout the study, researchers will monitor various health outcomes, including survival rates and improvements in lung function. The study will also assess the overall health of participants by looking at factors like organ function and pressure in the lungs. The goal is to gather information that could lead to better treatment options for people suffering from ARDS.

The research process

The trial runs in 4 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, the patient is confirmed to meet the inclusion criteria, which include being 18 years or older, having a diagnosis of moderate to severe acute respiratory distress syndrome (ARDS) within 48 hours, and requiring intubation and mechanical ventilation.

    The patient must have a negative COVID-19 test and provide informed consent to participate in the study.

  2. Step 2

    Treatment administration

    The patient receives the medication Kineret, which contains the active substance anakinra.

    The medication is administered as a subcutaneous injection using a pre-filled syringe containing 100 mg/0.67 ml of solution.

    The frequency and duration of administration are determined by the study protocol and the patient's condition.

  3. Step 3

    Monitoring and evaluation

    The primary goal is to evaluate the number of ventilation-free days the patient experiences.

    Secondary evaluations include 28-day mortality, ICU mortality, in-hospital mortality, and improvements in respiratory function, such as the PaO2/FiO2 ratio, driving pressure, peak pressure, and plateau pressure.

    The patient's overall organ function is assessed using the Sequential Organ Failure Assessment (SOFA) score, with a focus on achieving a score of less than 2 by day 28.

  4. Step 4

    Study duration

    The study is expected to conclude by May 3, 2025.

    The patient's participation in the study is monitored throughout this period, with regular assessments and adjustments to treatment as necessary.

Who can join the trial?

9 criteria

  • Must be **18 years or older**.
  • Can be **any gender**.
  • Must be admitted to the **Intensive Care Unit (ICU)** with a diagnosis of **moderate to severe Acute Respiratory Distress Syndrome (ARDS)** within 48 hours. This means having a specific breathing problem that requires a machine to help with breathing.
  • Must meet the **Berlin criteria** for ARDS, which includes symptoms starting within one week of an injury or new/worsening breathing problems, and specific findings on a chest scan that are not due to other causes like heart failure.
  • Must have an **ARDS-like profile** based on at least one of the following:
    • High levels of certain **inflammatory markers** in the blood, such as IL-6 or PCR.
    • Need for **vasopressors**, which are medications that help maintain blood pressure, for at least one hour.
    • Low levels of **bicarbonate** in the blood or high levels of **lactate**, which are indicators of certain metabolic conditions.
    • Must provide **informed consent**, meaning they agree to participate after understanding the study.
    • Must have a **negative test for COVID-19**.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing Acute Respiratory Distress Syndrome (ARDS). ARDS is a severe lung condition that causes difficulty in breathing.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

Anakinra is a medication used in this study to assess its effectiveness and safety in treating acute respiratory distress syndrome (ARDS) that is not related to COVID-19. The study aims to determine if this medication can help increase the number of days patients can breathe without the assistance of a ventilator.

What is already known about the treatment

Anakinra – Anakinra is administered through subcutaneous injection, meaning it is injected under the skin. It is currently being studied for its effectiveness and safety in treating acute respiratory distress syndrome (ARDS) not related to COVID-19. The main therapeutic use of Anakinra is to reduce inflammation in conditions like rheumatoid arthritis, and it is being explored for ARDS to potentially increase ventilation-free days. At the molecular level, Anakinra works by blocking the activity of interleukin-1, a protein that plays a key role in inflammation. It is classified as an interleukin-1 receptor antagonist in pharmacology.

Investigated diseases

Acute Respiratory Distress Syndrome (ARDS) – This is a severe lung condition that occurs when fluid builds up in the tiny, elastic air sacs in the lungs. The fluid prevents the lungs from filling with enough air, which means less oxygen reaches the bloodstream. This can lead to organs not getting 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 cause severe shortness of breath and requires immediate medical attention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518125-15-00Protocol codeCARR-ARDS-2021Estimated enrolment36 patientsSponsorAzienda Sanitaria Universitaria Friuli Centrale

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