Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.

Summary

The study objective is to assess Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.

Timeline

Start

2021-02-14

Primary completion

2021-09-30

Completion

2021-10-31

Outcome

Missed primary endpoint

registry analysis (superiority test); Reparixin vs Placebo; p = 0.216; Odds Ratio (OR) 1.626 (95% CI 0.752 to 3.514); NCT04878055 ↗

paper CONCLUSIONS: This trial did not meet the primary efficacy endpoints PMID 37798468 ↗

Publications

• Piemonti L, Landoni G, Voza A, Puoti M, Gentile I, Coppola N, Nava S, Mattei A, Marinangeli F, Marchetti G, Bonfanti P, Mastroianni CM, Bassetti M, Crisafulli E, Grossi PA, Zangrillo A, Desai A, Merli M, Foggia M, Carpano M, Schiavoni L, D'Arminio Monforte A, Bisi L, Russo G, Busti F, Rovelli C, Perrotta E, Goisis G, Gavioli EM, Toya S, De Pizzol M, Mantelli F, Allegretti M, Minnella EM. Efficacy and Safety of Reparixin in Patients with Severe COVID-19 Pneumonia: A Phase 3, Randomized, Double-Blind Placebo-Controlled Study. Infect Dis Ther. 2023 Oct;12(10):2437-2456. doi: 10.1007/s40121-023-00871-5. Epub 2023 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Reparixin	Small molecule	1200 mg	Oral

Indications