Zilucoplan in patients with acute hypoxic respiratory failure due to COVID-19 (ZILU-COV): A structured summary of a stud
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Open Access
Zilucoplan in patients with acute hypoxic respiratory failure due to COVID-19 (ZILUCOV): A structured summary of a study protocol for a randomised controlled trial Jozefien Declercq1†, Cedric Bosteels1†, Karel Van Damme1†, Elisabeth De Leeuw1†, Bastiaan Maes1†, Ans Vandecauter2, Stefanie Vermeersch2, Anja Delporte2, Bénédicte Demeyere2, Marnik Vuylsteke3, Marianna Lalla4, Trevor Smart5, Laurent Detalle4, René Bouw4, Johannes Streffer4, Thibo Degeeter6, Marie Vergotte6, Tanguy Guisez6, Eva Van Braeckel2, Catherine Van Der Straeten2 and Bart N. Lambrecht1*
Abstract Objectives: Zilucoplan (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms that lead to improvement in lung oxygenation parameters. The purpose of this study is to investigate the efficacy and safety of Zilucoplan in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. Trial design: This is a phase 2 academic, prospective, 2:1 randomized, open-label, multi-center interventional study. Participants: Adult patients (≥18y old) will be recruited at specialized COVID-19 units and ICUs at 9 Belgian hospitals. The main eligibility criteria are as follows: 1) Inclusion criteria: a. Recent (≥6 days and ≤16 days) SARS-CoV-2 infection. b. Chest CT scan showing bilateral infiltrates within the last 2 days prior to randomisation. c. Acute hypoxia (defined as PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen). d. Signs of cytokine release syndrome characterized by either high serum ferritin, or high D-dimers, or high LDH or deep lymphopenia or a combination of those. 2) Exclusion criteria: e. Mechanical ventilation for more than 24 hours prior to randomisation. f. Active bacterial or fungal infection. g. History of meningococcal disease (due to the known high predisposition to invasive, often recurrent meningococcal (Continued on next page)
* Correspondence: [email protected] † Jozefien Declerq, Cedric Bosteels, Karel Van Damme, Elisabeth De Leeuw and Bastiaan Maes contributed equally to this work and are joint first authors. 1 VIB Center for Inflammation Research, Ghent, Belgium and Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use
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