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NCT05496868 · ClinicalTrials.gov registry record · Phase 2
Add-on Reparixin in Adult Patients With ARDS
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT05496868: Completed Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
NCT05496868 is a Phase 2 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05496868, a Phase 2 study, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study 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.
Primary Outcome
Oxygenation Index is defined as Mean Airway Pressure multiplied by (Fraction of Inspired Oxygen\[FiO2\]) x (100)/(Partial Pressure of Oxygen\[PaO2\]). It is a measure of efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to estimand definition. If a participant died before or at Day 7 and OI was missing,
Interventions
- OTHER Matching Placebo
- DRUG Reparixin 600mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-12-06 |
| Est. Completion | 2025-04-18 |
| Phase | Phase 2 |
What the finished NCT05496868 record still lists
NCT05496868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT05496868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05496868 about?
NCT05496868 is a clinical study titled "Add-on Reparixin in Adult Patients With ARDS". 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 reparixi...
What is the current status of trial NCT05496868?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2022-12-06. Estimated completion is 2025-04-18.
What interventions are being tested in trial NCT05496868?
The interventions under investigation include: Matching Placebo (OTHER), Reparixin 600mg (DRUG).
Who is sponsoring clinical trial NCT05496868?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05496868's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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