Efficacy and Safety of Reparixin in Patients with Severe COVID-19 Pneumonia: A Phase 3, Randomized, Double-Blind Placebo-Controlled Study

• DOI: 10.1007/s40121-023-00871-5
• Publication Date: 2023-10-05T16:01:56Z
• Authors: Lorenzo Piemonti; Giovanni Landoni; Antonio Voza; Massimo Puoti; Ivan Gentile; Nicola Coppola; Stefano Nava; Alessia Mattei; Franco Marinangeli; Giulia Marchetti; Paolo Bonfanti; Claudio Maria Mas...; Matteo Bassetti; Ernesto Crisafulli; Paolo Antonio Grossi; Alberto Zangrillo; Antonio Desai; Marco Merli; Maria Foggia; Marco Carpano; Lorenzo Schiavoni; Antonella D’Armin...; Luca Bisi; Gianluca Russo; Fabiana Busti; Cristina Rovelli; Elisabetta Perrotta; Giovanni Goisis; Elizabeth M. Gavioli; Sophie Toya; Maria De Pizzol; Flavio Mantelli; Marcello Allegretti; Enrico Maria Minn...
• Keywords: Clinical endpoint

Polymorphonuclear cell influx into the interstitial and bronchoalveolar spaces is a cardinal feature of severe coronavirus disease 2019 (COVID-19), principally mediated by interleukin-8 (IL-8). We sought to determine whether reparixin, novel IL-8 pathway inhibitor, could reduce progression in patients hospitalized with COVID-19 pneumonia.In this Phase 3, randomized, double-blind, placebo-controlled, multicenter study, adult pneumonia were randomized 2:1 receive oral reparixin 1200 mg three times daily or placebo for up 21 days until hospital discharge. The primary endpoint was proportion alive free respiratory failure at Day 28, key secondary endpoints being 60, incidence intensive care unit (ICU) admission 28 time recovery 28.Of 279 182 received least one dose 88 placebo. similar two groups {83.5% versus 80.7%; odds ratio 1.63 [95% confidence interval (CI) 0.75, 3.51]; p = 0.216}. There no statistically significant differences endpoints, but numerically higher group 60 (88.7% 84.6%; 0.195), fewer required ICU admissions (15.8% 21.7%; 0.168), recovered compared (81.6% 74.9%; 0.167). Fewer experienced adverse events than (45.6% 54.5%), most mild moderate intensity not related study treatment.This trial did meet efficacy yet showed trend toward limiting as an add-on therapy well tolerated.ClinicalTrials.gov: NCT04878055, EudraCT: 2020-005919-51.