Add-on Reparixin in Adult Patients With ARDS

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.

Timeline

Start

2022-12-06

Primary completion

2025-03-18

Completion

2025-04-18

Outcome

Missed primary endpoint

registry analysis (superiority test); Reparixin vs Placebo; p = 0.735; Adjusted mean difference 1.3 (95% CI -2.1 to 4.7); ANOVA NCT05496868 ↗

registry analysis (superiority test); Reparixin vs Placebo; p = 0.625; Adjusted mean difference -0.9 (95% CI -5.6 to 3.8); ANOVA NCT05496868 ↗

Publications

• Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reparixin	Small molecule	1200 mg	Other

Indications