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Add-on Reparixin in Adult Patients With ARDS

NCT05496868 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-11

Study results available
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Summary

Study objectives

1. To characterize the efficacy of reparixin in ameliorating lung injury and systemic inflammation and expediting clinical recovery and liberation from mechanical ventilation in adult patients with moderate to severe ARDS (PaO2/FIO2 ratio ≤ 200).
2. to assess the effect of reparixin on systemic biomarkers linked to a hyper-inflammatory ARDS phenotype.
3. To evaluate the safety of reparixin vs. placebo in patients enrolled in the study.

Conditions

  • Acute Respiratory Distress Syndrome, Adult

Interventions

DRUG

Reparixin 600mg

Reparixin 600 mg tablets, administered crushed through nasogastric tube at the dose of 1200 mg TID (2 tablets TID administered approximately about every 8 hours) as add-on to the standard of care. After extubation and if the patient can swallow, reparixin may be administered orally. Total duration of the treatment: 14 days

OTHER

Matching Placebo

Placebo tablets. Administered crushed through nasogastric tube with the same schedule as reparixin as add-on to the standard of care. After extubation and if the patient can swallow placebo may be administered orally. Total duration of the treatment: 14 days

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Moerer Onnen, MD · Universitaetsmedizin Goettingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2025-03-18
Completion
2025-04-18
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05496868 on ClinicalTrials.gov