Reparixin in COVID-19 Pneumonia - Efficacy and Safety

Summary

* Phase 2 Study Objectives: efficacy and safety of of Reparixin treatment as compared to the control arm in adult patients with severe COVID-19 pneumonia * Phase 3 Study Objectives: efficacy and safety of Reparixin treatment as compared to the control arm in adult patients with moderate or severe COVID-19 pneumonia

Timeline

Start

2020-05-05

Primary completion

2020-11-27

Completion

2021-02-02

Outcome

Met primary endpoint

Stopped: “The sponsor has decided to start with a separate protocol for phase 3 and therefore this study was terminated with only phase 2.”

paper The rate of clinical events was statistically significantly lower in the reparixin group compared with the SOC group (16.7% [95% CI 6.4-32.8%] PMID 35618953 ↗

registry analysis (superiority test); Reparixin (FAS) vs Standard of Care (FAS); p = 0.02164; Log Rank NCT04794803 ↗

release “The Phase 2 REPAVID-19 clinical trial of reparixin in hospitalized patients with severe COVID-19 pneumonia, (NCT04794803) which achieved its primary endpoint” dompe.com ↗

release “In hospitalized patients with COVID-19 Pneumonia, the rates of clinical events among those treated with Reparixin (n=36) were statistically significantly lower than standard of care” dompe.com ↗

Publications

• Landoni G, Piemonti L, Monforte AD, Grossi P, Zangrillo A, Bucci E, Allegretti M, Goisis G, Gavioli EM, Patel N, De Pizzol M, Pasedis G, Mantelli F. A Multicenter Phase 2 Randomized Controlled Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients with COVID-19 Pneumonia. Infect Dis Ther. 2022 Aug;11(4):1559-1574. doi: 10.1007/s40121-022-00644-6. Epub 2022 May 26.

Drugs

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

Indications