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<p>COVID-19 severity is strongly associated with hyperinflammation. Cyclosporine A (CSA), an interleukin-2 inhibitor with immunomodulatory and antiviral activity, has been proposed as a potential adjunctive therapy. This study evaluated the safety and efficacy of CSA in patients with moderate to severe COVID-19. We conducted A randomized, open-label phase III trial was conducted involving 66 patients with COVID-19. Participants were assigned to one of two groups: the CSA group (n = 23), receiving 6&#xa0;mg/kg/day for 7–14&#xa0;days, and a standard treatment group (n = 43). Clinical improvement (WHO ordinal scale) was the main goal, with C-reactive protein (CRP), ferritin, interleukin-6 ( IL-6), and D-dimer, and safety monitoring for 28&#xa0;days as secondary outcomes significant differences in enrolment. The time to clinical improvement was significantly shorter in the CSA group (4.3 ± 1.0 vs. 5.1 ± 2.3&#xa0;days; <i>p</i> = 0.025). Oxygen supplementation was used in 7 patients (30.43%) versus 12 patients (27.91%) in the standard group, with a <i>p</i>-value of 0.828. No significant differences occurred in the WHO ordinal scale, advanced respiratory support, or mortality. No secondary infections occurred. CSA improved oxygen saturation and reduced CRP and IL-6; differences in saturation at day 14 were not significant. D-dimer and ferritin levels were lower at day 14, with no differences observed at day 7. Cyclosporine did not significantly improve ordinal scale outcomes. However, it was associated with a shorter time to clinical improvement and favorable modulation of inflammatory markers in patients with COVID-19 and cytokine storm, without major safety concerns.</p>

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Effectiveness and safety of cyclosporine A in moderate to severe COVID-19: a randomized, open-label trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月17日

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  • Amira A. Zidan,
  • Ahmed Y. S. Gad,
  • Nermine H. Zakaria,
  • Hazem M. El-Hariri,
  • Noha M. Elsharnouby,
  • Maged W. Helmy,
  • Maged El-Setouhy

摘要

COVID-19 severity is strongly associated with hyperinflammation. Cyclosporine A (CSA), an interleukin-2 inhibitor with immunomodulatory and antiviral activity, has been proposed as a potential adjunctive therapy. This study evaluated the safety and efficacy of CSA in patients with moderate to severe COVID-19. We conducted A randomized, open-label phase III trial was conducted involving 66 patients with COVID-19. Participants were assigned to one of two groups: the CSA group (n = 23), receiving 6 mg/kg/day for 7–14 days, and a standard treatment group (n = 43). Clinical improvement (WHO ordinal scale) was the main goal, with C-reactive protein (CRP), ferritin, interleukin-6 ( IL-6), and D-dimer, and safety monitoring for 28 days as secondary outcomes significant differences in enrolment. The time to clinical improvement was significantly shorter in the CSA group (4.3 ± 1.0 vs. 5.1 ± 2.3 days; p = 0.025). Oxygen supplementation was used in 7 patients (30.43%) versus 12 patients (27.91%) in the standard group, with a p-value of 0.828. No significant differences occurred in the WHO ordinal scale, advanced respiratory support, or mortality. No secondary infections occurred. CSA improved oxygen saturation and reduced CRP and IL-6; differences in saturation at day 14 were not significant. D-dimer and ferritin levels were lower at day 14, with no differences observed at day 7. Cyclosporine did not significantly improve ordinal scale outcomes. However, it was associated with a shorter time to clinical improvement and favorable modulation of inflammatory markers in patients with COVID-19 and cytokine storm, without major safety concerns.