Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

Summary

Primary objective: \- To compare the efficacy of reparixin vs. placebo in the proportion of patients dead or requiring IMV (or ECMO) by Day 28. Key secondary objectives: * To compare the efficacy of reparixin vs placebo in all-cause mortality at day 180. * To compare the efficacy of reparixin vs placebo in proportion of patients alive and discharged at day 28 * To compare the efficacy of reparixin vs placebo in ventilatory-free days at day 28. * To compare the efficacy of reparixin vs placebo in proportion of patients with IMV (or ECMO) by day 28. * To compare the efficacy of reparixin vs placebo in length of primary hospital stay. Other efficacy objectives \- To compare the efficacy of reparixin vs placebo on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: \- To evaluate safety and tolerability of oral reparixin versus placebo in the specific clinical setting.

Timeline

Start

2022-04-27

Primary completion

2024-07-29

Completion

2024-09-27

Outcome

Outcome not reported

Stopped: “The study was stopped due to futility as per protocol”

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

Indications