Multinational, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase III trial.~It will enrol 526 male and female patients >18 years, hospitalised for CAP (including COVID-19), assigned (1:1) to receive either oral reparixin (treatment group) or matched placebo (control group) three times a day (TID) for up to 21 days. Randomisation will be stratified according to disease severity and site.~All the patients will receive the standard of care based on their clinical need, including COVID-19 and CAP medications, as per local standard therapy at the trial site and in line with international guidelines.~The primary outcome will be evaluated at day 28, secondary will be evaluated from day 3 to day 180.~An independent external data monitoring committee (DMC) will oversee the study and evaluate unblinded interim data for efficacy, futility, and safety.
Primary objective:~- To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19.~Secondary objectives:~- To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality.~Safety objectives:~- To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.