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NCT05496868
Add-on Reparixin in Adult Patients With ARDS
Phase 2 trial testing Reparixin 600mg in Acute Respiratory Distress Syndrome, Adult in 66 participants. Completed in 18 April 2025.
18 March 2025
Quick facts
| Lead sponsor | Dompé Farmaceutici S.p.A |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 6 December 2022 |
| Primary completion | 18 March 2025 |
| Estimated completion | 18 April 2025 |
| Sites | 40 locations across Italy, United States, Germany |
Drugs / interventions tested
- Reparixin 600mg — full drug profile →
- Matching Placebo — full drug profile →
Conditions studied
- Acute Respiratory Distress Syndrome, Adult — all drugs for Acute Respiratory Distress Syndrome, Adult →
Sponsor
Dompé Farmaceutici S.p.A — full company profile →
Who can join
18 and older, any sex, with Acute Respiratory Distress Syndrome, Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dysregulation of Neutrophil-Endothelial Communication in Sepsis: Mechanisms and Therapeutic Perspectives.
Esmalian Afyouni N, Kiani MF, Kilpatrick LE. · · 2026 · PMID 41972674 · DOI 10.3390/cells15070581
Verify or expand the search:
- PubMed search for NCT05496868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05496868 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dompé Farmaceutici S.p.A
- Last refreshed: 27 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05496868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing