Not recruiting

Study on the Effectiveness and Safety of Reparixin for Adults with Acute Respiratory Distress Syndrome

Verified siteInvestigationalNo 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), which is a severe lung condition that causes difficulty in breathing. The study is testing a medication called Reparixin, which is taken as a tablet. Reparixin is being investigated to see if it can help improve lung function and reduce inflammation in patients with ARDS. The trial will also compare the effects of Reparixin with a placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate how effective and safe Reparixin is when used alongside the standard care for ARDS. Participants in the study will receive either Reparixin or a placebo, and their progress will be monitored over a period of time. The study aims to see if Reparixin can help patients recover more quickly and reduce their need for mechanical ventilation, which is a machine that helps with breathing.

Throughout the study, researchers will observe changes in the patients' lung function and overall health. They will also look at specific markers in the blood that are linked to inflammation. The study will last for several weeks, and the results will help determine if Reparixin can be a beneficial treatment for people 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.

Step 1
Joining the study
Participation begins after signing an informed consent form. This confirms understanding and agreement to participate in the study.
Eligibility is confirmed based on criteria such as age, medical condition, and current treatment status.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health status. This includes measuring oxygen levels and other health indicators.
Step 3
Medication administration
Participants receive either reparixin or a placebo. Both are administered in tablet form for oral use.
The dosage and frequency of administration are determined by the study protocol and are monitored by the medical team.
Step 4
Monitoring and follow-up
Health status is monitored regularly to assess the effects of the medication. This includes checking oxygen levels and other vital signs.
Regular assessments are conducted on days 2, 3, 4, 7, 14, and 28 to evaluate progress and any changes in health status.
Step 5
Completion of treatment phase
The primary treatment phase concludes on day 28. The number of days without the need for a ventilator is recorded.
Additional health assessments are conducted to evaluate recovery and any remaining symptoms.
Step 6
Final assessment and study conclusion
A final assessment is conducted to evaluate overall health and recovery status.
The study concludes with a review of all collected data to determine the efficacy and safety of the treatment.

Who can join the trial?

7 criteria

The patient must provide a signed informed consent, following local guidelines and rules.
The patient must be an adult, meaning they are over 18 years old.
The patient must be on a breathing machine (mechanically ventilated) with a specific measurement called the **PaO2/FIO2 ratio** being 200 or less, and a **PEEP** (a setting on the breathing machine) of 5 cm H2O or more.
The patient's breathing problems should not be completely due to heart problems or too much fluid in the body. If heart failure is part of the problem, it should be treated quickly before joining the study.
The patient must have certain findings on a chest x-ray or CT scan that show signs of fluid in the lungs, known as **pulmonary edema** or **ground glass opacities**.
The patient must be enrolled in the study within 48 hours of meeting the above criteria. If transferred from another hospital, an extra 12 hours is allowed.
Females who can have children and are sexually active must agree not to become pregnant for 30 days after the last dose of the study drug. They must use reliable birth control methods, such as hormonal birth control, a sterile partner, or abstinence. If the patient cannot consent due to illness, a legal representative must assure this, and the patient must confirm when able. Females who cannot have children or have been in menopause for at least a year can join. A negative pregnancy test is required before starting the study drug.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to similar medications are excluded.
Patients with other serious health conditions that might interfere with the study are not eligible.
People who have participated in another clinical trial recently are not allowed to join.
Individuals with a history of drug or alcohol abuse may be excluded.
Patients who are unable to follow the study procedures or instructions cannot participate.
Anyone with a mental health condition that affects their ability to consent or comply with the study is excluded.
Patients with certain infections that could affect the study results are not eligible.
Individuals who have received certain treatments that might interfere with the study are excluded.
Patients with a history of certain lung diseases that are not related to the study condition cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Ospedale San Raffaele S.r.l.
Milan, Italy
Verified
Universitaet Leipzig
Leipzig, Germany
Verified
Universitaetsklinikum Essen AöR
Essen, Germany

Trial locations

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Investigated drugs

Reparixin is being studied as an additional treatment to the usual care for adults with Acute Respiratory Distress Syndrome (ARDS). The trial aims to see if reparixin can help reduce lung damage and inflammation, speed up recovery, and help patients come off mechanical ventilation sooner. The study also looks at how reparixin affects certain markers in the body that are linked to a more severe form of ARDS.

Reparixin

What is already known about the treatment

Reparixin – Reparixin is administered orally and is currently being studied in clinical trials for its potential benefits in treating Acute Respiratory Distress Syndrome (ARDS). It is in the phase 2 stage of clinical trials, where its efficacy and safety are being evaluated. The main therapeutic indication for reparixin is to reduce lung injury and systemic inflammation in patients with ARDS, potentially aiding in faster recovery and reducing the need for mechanical ventilation. At the molecular level, reparixin works by inhibiting the activity of certain proteins involved in the inflammatory response, thereby reducing inflammation. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Acute Respiratory Distress Syndrome – Acute Respiratory Distress Syndrome (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. 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 leads to severe shortness of breath and requires medical intervention, often involving mechanical ventilation. The progression of ARDS can vary, but it generally involves worsening respiratory function and increased difficulty in breathing.