At a glance
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Phase 2, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Assess Efficacy and Safety of Reparixin as add-on Therapy to SoC in Acute Respiratory Distress Syndrome (RESPIRATIO)
In Brief
A Phase 2 clinical trial evaluating Reparixin 600mg and Matching Placebo for Acute Respiratory Distress Syndrome, Adult. Completed, enrolled 66 participants across 40 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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
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