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NCT05254990 · ClinicalTrials.gov registry record · Phase 3
Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia
A Phase 3 study, sponsored by Dompé Farmaceutici S.p.A.
- Terminated
- Registry status
- Phase 3
- Development phase
- 414
- Enrollment target
NCT05254990: Clinical Trial Phase 3 study, sponsored by Dompé Farmaceutici S.p.A.
NCT05254990 is a Phase 3 study that was terminated before completion, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 414 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05254990, a Phase 3 study, was terminated before completion, sponsored by Dompé Farmaceutici S.p.A.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 414 participants
- Enrollment target
Study Summary
Primary objective: \- To compare the efficacy of reparixin vs. placebo in the proportion of patients dead or requiring IMV (or ECMO) by Day 28. Key secondary objectives: * To compare the efficacy of reparixin vs placebo in all-cause mortality at day 180. * To compare the efficacy of reparixin vs placebo in proportion of patients alive and discharged at day 28 * To compare the efficacy of reparixin vs placebo in ventilatory-free days at day 28. * To compare the efficacy of reparixin vs placebo in proportion of patients with IMV (or ECMO) by day 28. * To compare the efficacy of reparixin vs placebo in length of primary hospital stay. Other efficacy objectives \- To compare the efficacy of reparixin vs placebo on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: \- To evaluate safety and tolerability of oral reparixin versus placebo in the specific clinical setting.
Primary Outcome
The primary endpoint was based on NIAID-OS ordinal scale (National Institute of Allergy and Infectious Disease) with score OS 7 which means patients "hospitalized, on invasive mechanical ventilation or ECMO". The scores on this scale of Disease severity range from OS 1 (best outcome) to OS 8 (worst outcome). NIAID-OS (National Institute of Allergy and Infectious Disease Ordinal Scale) SCORE Descriptor: * OS 1 Not hospitalized, no limitations on activities; * OS 2 Not hospitalized, limitation
Interventions
- OTHER Placebo
- DRUG Reparixin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 3 |
Why NCT05254990 stopped before completion
NCT05254990 is an interventional study that assigns participants to a tested intervention. The registered 414 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05254990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05254990 about?
NCT05254990 is a clinical study titled "Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia". Primary objective: \- To compare the efficacy of reparixin vs. placebo in the proportion of patients dead or requiring IMV (or ECMO) by Day 28. Key secondary objectives: * To compare the efficacy of reparixin vs placebo in all-cause mortality at day 180. * To compare the efficacy of reparixin vs ...
What is the current status of trial NCT05254990?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 414 participants. The study started on 2022-04-27. Estimated completion is 2024-09-27.
What interventions are being tested in trial NCT05254990?
The interventions under investigation include: Placebo (OTHER), Reparixin (DRUG).
Who is sponsoring clinical trial NCT05254990?
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 NCT05254990's enrollment target sits among peer trials
414 905th of 2000 higher than 1,096 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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