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A Randomized Controlled Clinical Trial on Efficacy and Safety of Anakinra in Patients With Severe Covid-19 Publisher Pubmed



Kharazmi AB1 ; Moradi O2 ; Haghighi M3, 4 ; Kouchek M5 ; Manafirasi A6 ; Raoufi M7 ; Shoaei D3, 4 ; Hadavand F3, 4 ; Nabavi M3, 4 ; Miri MM5 ; Salarian S5 ; Shojaei S5 ; Khalili S1 ; Sistanizad M2, 8 Show All Authors
Authors
  1. Kharazmi AB1
  2. Moradi O2
  3. Haghighi M3, 4
  4. Kouchek M5
  5. Manafirasi A6
  6. Raoufi M7
  7. Shoaei D3, 4
  8. Hadavand F3, 4
  9. Nabavi M3, 4
  10. Miri MM5
  11. Salarian S5
  12. Shojaei S5
  13. Khalili S1
  14. Sistanizad M2, 8
  15. Sadeghi S9
  16. Karagah A2
  17. Asgari S10
  18. Jaffaraghaei M11
  19. Araghi S12

Source: Immunity# Inflammation and Disease Published:2022


Abstract

Introduction: Hyperinflammatory state has a role in the pathogenesis of COVID-19. Anakinra could reduce inflammation and help to combat the condition. In this study, we aimed to assess the safety and efficacy of anakinra (PerkinRA®) in severe COVID-19. Method: The study was an open-label, randomized, controlled trial conducted in Imam Hossein Medical Center from May to July 2020. Patients with a confirmed diagnosis of COVID-19 were included in this study. We administered anakinra 100 mg daily intravenously. All patients received COVID-19 pharmacotherapy based on the represented national guideline. The need for invasive mechanical ventilation is considered the primary outcome. Results: Thirty patients were included in this study, and 15 of them received Anakinra. Nineteen patients were male (63.3%), and 11 were female (36.7%). The mean age of patients was 55.77 ± 15.89 years. In the intervention group, the need for invasive mechanical ventilation was significantly reduced compared to the control group (20.0% vs. 66.7%, p =.010). Also, these patients had a significantly lower length of hospital stay (p =.043). No significant higher rate of infection was recorded. Conclusion: Anakinra as an immunomodulatory agent has been associated with the reduced need for mechanical ventilation in patients admitted to intensive care units because of severe COVID-19. The medication reduced the hospital length of stay. Furthermore, no increased risk of infection was observed. Further randomized placebo-controlled trials with a larger sample size are needed to confirm these findings. © 2021 The Authors. Immunity, Inflammation and Disease published by John Wiley & Sons Ltd.
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