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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
Show Affiliations
Authors Affiliations
  1. 1. Department of Internal Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2. Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  3. 3. Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Tehran, Iran
  4. 4. Department of Infectious Diseases, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  5. 5. Department of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  6. 6. Department of Orthopedic Surgery, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  7. 7. Department of Radiology, Emam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  8. 8. Prevention of Cardiovascular Disease Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  9. 9. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  10. 10. Medical Biotechnology Department, Biotechnology Research Center, Pasteur Institute of Iran, Tehran, Iran
  11. 11. PersisGen Par Company, Alborz, Iran
  12. 12. Department of Microbiology, Faculty of Advanced Science and Technology, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran

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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