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Experimental drug aims to help ARDS patients breathe easier

NCT ID NCT05496868

Disease control Sponsor: Dompé Farmaceutici S.p.A Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested whether adding reparixin, an anti-inflammatory drug, to standard care could improve lung function in adults with moderate to severe acute respiratory distress syndrome (ARDS). The study enrolled 66 patients on mechanical ventilators. Researchers measured changes in oxygenation and how many days patients were free from the ventilator. The goal was to see if reparixin could speed recovery and reduce inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Reparixin (an experimental anti-inflammatory drug)
What this could lead to
If successful, reparixin could help reduce lung injury and shorten the time patients with ARDS need a ventilator, potentially improving recovery.
What could go wrong
This is an early Phase 2 trial with only 66 participants, so results may not apply to all ARDS patients. The drug may not show clear benefit over standard care, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Dec 2022

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed Informed Consent, according to local guidelines and regulation. 2. Male and female adults (\>18 years old). 3. Mechanically ventilated (invasive) patients with PaO2/FIO2 ratio ≤200 in the presence of PEEP of ≥5 cmH20. 4. Respiratory failure not fully explained by cardiac failure or fluid overload (if acute Congestive Heart Failure exacerbation is identified as part of the clinical picture this should be addressed effectively and as soon as possible before the patient can be enrolled). 5. Bilateral radiologic opacities consistent with pulmonary edema on the frontal chest x-ray (CXR), or bilateral ground glass opacities on a chest computerized tomography (CT) scan. 6. ≤48 hours from fulfilling above ARDS criteria (if a patient is transferred from a non-participating hospital to a participating site a 12-hour period beyond the 48 hours is allowed) 7. Females of child-bearing potential who are sexually active must be willing not to get pregnant within 30 days after the last Investigational Medicinal Product (IMP) dose and must agree to at least one of the following reliable methods of contraception: 1. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives from at least 2 months before the screening visit until 30 days after the last IMP dose; 2. A sterile sexual partner; 3. Abstinence. In patients non able to personally consent to above due to complications of acute illness and/or its treatment assurances for the above must be given by LR and reiterated by patient when/if she is able to do so. Female participants of non-child-bearing potential or in post- menopausal status for at least 1 year will be admitted. For all female subjects with child-bearing potential, pregnancy test result must be negative before first drug intake. Exclusion Criteria: 1. Moderate-Severe chronic hepatic disease (as verified by a previously known Child-Pugh score ≥7). If baseline Child-Pugh score is not known it should not be calculated while the patient is acutely ill. In that case the patient is excluded on the basis of: ALT/AST ≥ 3x ULN and total bilirubin \> 2x ULN or ALT/AST ≥ 5x ULN 2. Severe chronic renal dysfunction: eGFR (2021 CKD-EPI) \< 30 mL/min/1.73m2. If baseline (chronic) renal function is not known the patient is only excluded if in need of acute renal replacement therapy (currently on RRT or to be imminently placed on RRT) 3. Participation in another interventional clinical trial. 4. Patients that are clinically determined to have a high likelihood of death within the next 24 hours based on PI's estimation. 5. Currently receiving ECMO or high frequency oscillatory ventilation. 6. Anticipated extubation within 24 hours of screening. (In such cases re-screening is allowed if the patient is within the enrollment window). 7. Evidence of GI dysmotility as demonstrated by presence of all the following: persistent gastric distention and enteral feeding intolerability and persistent gastric residuals \>500 ml). 8. Anticipated transfer to a hospital not participating in the trial within 72 hours of screening. 9. Decision to withhold or withdraw life-sustaining treatment (patients may still be eligible however if they are committed to full support except cardiopulmonary resuscitation if cardiac arrest occurs). 10. History of: 1. Documented allergy/hypersensitivity to sulfonamides, ibuprofen and other COX-1 and 2 inhibitors, and to the study product and/or its excipients. 2. Lactase deficiency, galactosemia or glucose-galactose malabsorption. 3. History of peptic ulcer, GI bleeding or perforation due to previous NSAID therapy. 11. Active bleeding (excluding menses) from uncontrolled site that cannot be definitively resolved prior to enrollment. 12. Pregnant or lactating women. 13. Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception during the study and up to 30 days after the last IMP dose. For patients non able to personally consent to above due to complications of acute illness and/or its treatment assurances for the above must be given by LR and reiterated by patient when/if he/she is able to do so.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute respiratory distress syndrome, adult

Contacts and locations

Locations

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Baptist Hospitals of Southeast Texas

    Beaumont, Texas, 77701, United States

  • Baystate Health

    Springfield, Massachusetts, 01107, United States

  • Berufsgenossenschaftliche Kliniken Bergmannstrost

    Halle, Saxony-Anhalt, 6112, Germany

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cardiovoyage

    Denison, Texas, 75020, United States

  • Denver Health

    Denver, Colorado, 80204, United States

  • Detroit Medical Center

    Detroit, Michigan, 48201, United States

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Herzzentrum Muenster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Jackson Pulmonary Associates

    Jackson, Mississippi, 39202, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Methodist Hospitals of Northwest Indiana

    Gary, Indiana, 46404, United States

  • MyMichigan Medical Center Midland

    Midland, Michigan, 48670, United States

  • NYU Langone Brooklyn

    Brooklyn, New York, 11220, United States

  • New York University Langone Health

    New York, New York, 10016, United States

  • Newton Wellesley Hospital

    Newton, Massachusetts, 02462-1607, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35233, United States

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, Saxony, 4103, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075, Germany

  • University Hospital of Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105, Germany

  • University of California Irvine Health

    Orange, California, 92868, United States

  • University of Missouri Health Care

    Columbia, Missouri, 65212, United States

  • University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8894, United States

  • University of Utah Hospitals & Clinics

    Salt Lake City, Utah, 84108, United States

  • Unversity of California Davis Medical Center

    Sacramento, California, 95817, United States

  • Virginia Commonwealth University Health System

    Richmond, Virginia, 23298, United States

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

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