Phase 2, proof-of-concept, randomized, double-blinded, placebo-controlled, multicenter study to assess efficacy and safety of reparixin as add-on therapy to standard of care in adult patients with Acute Respiratory Distress Syndrome (RESPIRATIO)

Acute Respiratory Distress Syndrome

Change in oxygenation index (OI) from baseline to day 7 of treatment. The OI is defined as: % mean airway pressure x FIO2/PaO2, Ventilator free days (VFD) at day 28

Change in OI from baseline to day 4, Acute lung injury score [composite of PaO2/FIO2 ratio, PEEP, lung compliance (plateau airway pressure minus PEEP/TV) and extent of pulmonary infiltrates] at 2, 3, 7, 14 days (if still intubated), SOFA scores at 2, 3, 7, 14 days (if still intubated), Ventilatory ratio (product of minute ventilation and PaCO2) at 2, 3, 7, 14 days (if still intubated), Incidence of ECMO at day 14, Use of vasoactive medications at day 14, CXR assessment of pulmonary edema by "radiographic assessment of lung edema" (RALE) score at 2, 3, 7, 14 days, Percentage of patients achieving pressure support ventilation equal to 5 cm H20 with PEEP equal to 5 cm H20 for 2 hours (measure of weaning) by day 28 and hospital discharge, ICU-free days by day 28 and hospital discharge, Hospital-free days by day 28 and hospital discharge, Incidence of tracheostomies by day 28 and hospital discharge, Incidence of LTAC facility by day 28 and hospital discharge, All-cause mortality by day 28, Hospital discharge by day 28, All-cause mortality by day 60, Change from baseline to day 3, 7 and 14 in plasma levels of Il-6, IL-8, PAI-1, Plasma TNFr-1, ICAM-1 RAGE

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Germany, Italy