A Phase 2 Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Reparixin in Hospitalized Adult Patients with COVID-19 Pneumonia
Abstract
Rationale: Severe coronavirus disease 2019 (COVID-19) is associated with significant morbidity attributed from the complications of acute respiratory distress syndrome. Poor outcomes in severe COVID-19 patients have been related to cytokine release syndrome, which may be mediated by CX- C chemokine ligand 8/interleukin 8 (CXCL8/IL-8) acting through C-X-C chemokine receptor types 1 and 2 (CXCR1/2). The aim of this clinical trial was to determine if CXCR 1/2 blockade by reparixin, an IL-8 inhibitor, can improve clinical outcomes in hospitalized patients with severe COVID-19 pneumonia. Methods: This was a Phase 2, open-label, adaptive, multicenter, randomized trial in hospitalized adult patients, conducted in Italy and Brazil, with severe COVID-19 pneumonia between May and November 2020. Eligible patients had respiratory distress (respiratory rate ≥30 breaths/minute without oxygen and/or partial arterial oxygen pressure (PaO2)/fraction of inspiration O2 (FiO2) >100 to <300 mmHg), pneumonia confirmed by chest imaging, and elevated inflammatory markers. Patients were randomized 2:1 to receive oral reparixin 1200mg three times daily or the standard of care (SOC) for up to 21 days. Patients were followed for up to seven days after the end of treatment. The primary endpoint was defined as a composite of clinical events: use of supplemental oxygen, need for mechanical ventilation, intensivecare unit admission, and/or use of rescue medication. This study was funded by Dompé…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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