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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
Must not have
Severe chronic renal dysfunction: eGFR (MDRD) < 30 mL/min/1.73m2 or End Stage Renal Disease on renal replacement therapy
Evidence of gastrointestinal (GI) dysmotility e.g., due to acute pancreatitis or immediate post-op state, as demonstrated by persistent gastric distention, enteral feeding intolerability and/or persistent gastric residuals >500 ml
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, day 7, day 14
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is severely impaired or I am on dialysis.
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I have stomach movement issues due to pancreatitis or surgery, shown by bloating, feeding problems, or large stomach residuals.
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My blood pressure medication has significantly increased recently.
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I have had stomach bleeding or ulcers from taking NSAIDs.
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I have a moderate to severe liver condition.
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I am currently on ECMO or high frequency ventilation.
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I am currently experiencing bleeding or have a bleeding disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, day 7, day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, day 7, day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in oxygenation index (OI) from baseline to day 7 of treatment
Ventilator - respiratory equipment
Secondary study objectives
Change in oxigenation index (OI) from baseline to day 4
Communicable Diseases
Plasma levels (free and bound) of DF1681Y (acidic form of reparixin) and relevant metabolites (DF2188Y, DF2243Y, and ibuprofen (DF1674Y))

Trial 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)

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
51 Previous Clinical Trials
4,642 Total Patients Enrolled
Francesco Sergio, MD-PhDStudy DirectorDompè farmaceutici SpA
Enrico Minnella, MDStudy DirectorDompè farmaceutici SpA
3 Previous Clinical Trials
853 Total Patients Enrolled

Media Library

Reparixin + Standard of care Clinical Trial Eligibility Overview. Trial Name: NCT05496868 — Phase 2
Acute Respiratory Distress Syndrome Research Study Groups: Reparixin + Standard of care, Placebo + Standard of care
Acute Respiratory Distress Syndrome Clinical Trial 2023: Reparixin + Standard of care Highlights & Side Effects. Trial Name: NCT05496868 — Phase 2
Reparixin + Standard of care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496868 — Phase 2
~16 spots leftby Apr 2025
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