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De Leeuw, Elisabeth; Van Damme, Karel F. A.; Declercq, Jozefien; Bosteels, Cedric; Maes, Bastiaan; Tavernier, Simon J.; Detalle, Laurent; Smart, Trevor; Glatt, Sophie; Debeuf, Nincy; Deckers, Julie; Lameire, Sahine; Vandecasteele, Stefaan J.; De Neve, Nikolaas; Demedts, Ingel K.; Govaerts, Elke; Knoop, Christiane; Vanhove, Karolien; Moutschen, Michel; Terryn, Wim; Depuydt, Pieter; Van Braeckel, Eva; Haerynck, Filomeen; Hendrickx, Tine C. J.; [...]

Efficacy and safety of the investigational complement C5 inhibitor zilucoplan in patients hospitalized with COVID-19: an open-label randomized controlled trial

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  • Medientyp: E-Artikel
  • Titel: Efficacy and safety of the investigational complement C5 inhibitor zilucoplan in patients hospitalized with COVID-19: an open-label randomized controlled trial
  • Beteiligte: De Leeuw, Elisabeth; Van Damme, Karel F. A.; Declercq, Jozefien; Bosteels, Cedric; Maes, Bastiaan; Tavernier, Simon J.; Detalle, Laurent; Smart, Trevor; Glatt, Sophie; Debeuf, Nincy; Deckers, Julie; Lameire, Sahine; Vandecasteele, Stefaan J.; De Neve, Nikolaas; Demedts, Ingel K.; Govaerts, Elke; Knoop, Christiane; Vanhove, Karolien; Moutschen, Michel; Terryn, Wim; Depuydt, Pieter; Van Braeckel, Eva; Haerynck, Filomeen; Hendrickx, Tine C. J.; [...]
  • Erschienen: Springer Science and Business Media LLC, 2022
  • Erschienen in: Respiratory Research
  • Sprache: Englisch
  • DOI: 10.1186/s12931-022-02126-2
  • ISSN: 1465-993X
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>The efficacy and safety of complement inhibition in COVID-19 patients is unclear.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>A multicenter randomized controlled, open-label trial. Hospitalized COVID-19 patients with signs of systemic inflammation and hypoxemia (PaO<jats:sub>2</jats:sub>/FiO<jats:sub>2</jats:sub> below 350 mmHg) were randomized (2:1 ratio) to receive standard of care with or without the C5 inhibitor zilucoplan daily for 14 days, under antibiotic prophylaxis. The primary outcome was improvement in oxygenation at day 6 and 15.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>81 patients were randomly assigned to zilucoplan (n = 55) or the control group (n = 26). 78 patients were included in the safety and primary analysis. Most were men (87%) and the median age was 63 years. The mean improvement in PaO<jats:sub>2</jats:sub>/FiO<jats:sub>2</jats:sub> from baseline to day 6 was 56.4 mmHg in the zilucoplan group and 20.6 mmHg in the control group (mean difference + 35.8; 95% confidence interval (CI) − 9.4 to 80.9; p = 0.12), an effect also observed at day 15. Day 28 mortality was 9% in the zilucoplan and 21% in the control group (odds ratio 0.4; 95% CI 0.1 to 1.5). At long-term follow up, the distance walked in a 6-min test was 539.7 m in zilucoplan and 490.6 m in the control group (p = 0.18). Zilucoplan lowered serum C5b-9 (p &lt; 0.001) and interleukin-8 (p = 0.03) concentration compared with control. No relevant safety differences between the zilucoplan and control group were identified.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>Administration of zilucoplan to COVID-19 patients in this proof-of-concept randomized trial was well tolerated under antibiotic prophylaxis. While not reaching statistical significance, indicators of respiratory function (PaO<jats:sub>2</jats:sub>/FiO<jats:sub>2</jats:sub>) and clinical outcome (mortality and 6-min walk test) suggest that C5 inhibition might be beneficial, although this requires further research in larger randomized studies<jats:italic>.</jats:italic></jats:p> </jats:sec>
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