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Reparixin for Acute Respiratory Distress Syndrome
Phase 2
Recruiting
Led By Moerer Onnen, MD
Research Sponsored by Dompé Farmaceutici S.p.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Respiratory failure not fully explained by cardiac failure or fluid overload
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first patient first visit (fpfv) to the date of last patient last visit (lplv)
Awards & highlights
Study Summary
This trial will evaluate the effectiveness of a drug to improve lung injury & inflammation and help patients recover from ARDS. It will also assess the drug's safety.
Who is the study for?
Adults over 18 with moderate to severe ARDS, mechanically ventilated, and a specific oxygenation criterion. They must have been in the hospital for less than a week and not be likely to die within 24 hours or need extensive life support soon. Women of childbearing age must use contraception.Check my eligibility
What is being tested?
The trial is testing reparixin's effectiveness in improving lung function and reducing inflammation compared to a placebo in adults with ARDS. It also assesses safety and aims to help patients wean off mechanical ventilation sooner.See study design
What are the potential side effects?
Potential side effects may include reactions similar to those seen with NSAIDs since reparixin belongs to this drug class. These could involve digestive issues, risk of bleeding, kidney problems, or allergic reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My chest X-ray or CT scan shows signs of fluid in my lungs.
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My breathing issues are not just because of heart problems or fluid in my body.
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I am on a ventilator and have specific oxygen and pressure settings.
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I was admitted to the hospital less than a week ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ to day 3(±8h), 7±1 day, 14±2 day, 21±2 day, 28±2 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to day 3(±8h), 7±1 day, 14±2 day, 21±2 day, 28±2 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in oxygenation index (OI) from baseline to day 7 of treatment
Ventilator - respiratory equipment
Secondary outcome measures
Intubation (procedure)
All-cause mortality by day 28
All-cause mortality by day 60
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Reparixin + Standard of careExperimental Treatment1 Intervention
Reparixin tablets 1200 mg TID (2 tablets x 600 mg TID) as add-on to the standard of care (SoC).
Group II: Placebo + Standard of carePlacebo Group1 Intervention
Placebo tablets with the same schedule of reparixin, as add-on to the standard of care (SoC)
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Who is running the clinical trial?
Dompé Farmaceutici S.p.ALead Sponsor
49 Previous Clinical Trials
4,468 Total Patients Enrolled
Moerer Onnen, MDPrincipal InvestigatorUniversitaetsmedizin Goettingen
Francesco Sergio, MD-PhDStudy DirectorDompè farmaceutici SpA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely impaired or I am on dialysis.I am over 18 years old.I have stomach movement issues due to pancreatitis or surgery, shown by bloating, feeding problems, or large stomach residuals.I agree to use birth control during and up to 30 days after the study.My breathing issues are not just because of heart problems or fluid in my body.I am either not able to have children, have been in menopause for at least a year, or have a negative pregnancy test.My blood pressure medication has significantly increased recently.My chest X-ray or CT scan shows signs of fluid in my lungs.I agree to use effective birth control or abstain from sex during the study.I am allergic to more than one sulfonamide medication.I have had stomach bleeding or ulcers from taking NSAIDs.I am on a ventilator and have specific oxygen and pressure settings.You have a condition that makes it difficult for your body to process lactose or galactose.I was diagnosed with ARDS less than 48 hours ago.I was admitted to the hospital less than a week ago.The doctor thinks you might pass away within the next day.You have signs of brain damage from lack of oxygen.I am expected to be taken off a ventilator within 24 hours of joining.I have a moderate to severe liver condition.I am currently on ECMO or high frequency ventilation.I have an active cancer other than non-melanoma skin cancer.You are allergic to ibuprofen.You have decided not to receive life-saving treatment, except for CPR if your heart stops.I am currently experiencing bleeding or have a bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Reparixin + Standard of care
- Group 2: Placebo + Standard of care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitments still taking place for this clinical experiment?
"Indeed, clinicaltrials.gov provides evidence that this investigation is actively sourcing possible participants. This trial was initially introduced on February 7th 2023 and most recently modified on the 24th of the same month. 66 people are required to be recruited from 30 distinct medical facilities for completion."
Answered by AI
Does the FDA sanction the use of Reparixin in combination with accepted medical practices?
"A score of 2 was given to Reparixin + Standard of care as there is evidence for its safety, yet no documentation has been found proving the efficacy."
Answered by AI
What is the uppermost number of participants in this investigation?
"This medical study necessitates 66 eligible candidates. Different locations, such as Banner - University Medical Center Phoenix in Phoenix and University of Southern California in Los Angeles, are providing patients with the opportunity to take part."
Answered by AI
How widespread is the implementation of this trial?
"Banner - University Medical Center Phoenix in Phoenix, Arizona, the University of Southern California in Los Angeles, and the University of California Irvine Health in Orange are three primary sites for this medical trial. Additionally, there are 30 other places around the United States involved with the study."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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