A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19
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, ran...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2022-02-01
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| Series: | Immunity, Inflammation and Disease |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/iid3.563 |
| _version_ | 1818744830313889792 |
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| author | Amir Behnam Kharazmi Omid Moradi Mehrdad Haghighi Mehran Kouchek Alireza Manafi‐Rasi Masoomeh Raoufi Simin Dokht Shoaei Fahimeh Hadavand Mahmood Nabavi Mir Mohammad Miri Sara Salarian Seyedpouzhia Shojaei Shayesteh Khalili Mohammad Sistanizad Setayesh Sadeghi Amirhossein Karagah Saemeh Asgari Morteza Jaffaraghaei Shahram Araghi |
| author_facet | Amir Behnam Kharazmi Omid Moradi Mehrdad Haghighi Mehran Kouchek Alireza Manafi‐Rasi Masoomeh Raoufi Simin Dokht Shoaei Fahimeh Hadavand Mahmood Nabavi Mir Mohammad Miri Sara Salarian Seyedpouzhia Shojaei Shayesteh Khalili Mohammad Sistanizad Setayesh Sadeghi Amirhossein Karagah Saemeh Asgari Morteza Jaffaraghaei Shahram Araghi |
| author_sort | Amir Behnam Kharazmi |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-18T02:50:32Z |
| format | Article |
| id | doaj.art-0b7715e22add4755a6232ef7e5c73537 |
| institution | Directory Open Access Journal |
| issn | 2050-4527 |
| language | English |
| last_indexed | 2024-12-18T02:50:32Z |
| publishDate | 2022-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Immunity, Inflammation and Disease |
| spelling | doaj.art-0b7715e22add4755a6232ef7e5c735372022-12-21T21:23:28ZengWileyImmunity, Inflammation and Disease2050-45272022-02-0110220120810.1002/iid3.563A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19Amir Behnam Kharazmi0Omid Moradi1Mehrdad Haghighi2Mehran Kouchek3Alireza Manafi‐Rasi4Masoomeh Raoufi5Simin Dokht Shoaei6Fahimeh Hadavand7Mahmood Nabavi8Mir Mohammad Miri9Sara Salarian10Seyedpouzhia Shojaei11Shayesteh Khalili12Mohammad Sistanizad13Setayesh Sadeghi14Amirhossein Karagah15Saemeh Asgari16Morteza Jaffaraghaei17Shahram Araghi18Department of Internal Medicine, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Clinical Pharmacy, Faculty of Pharmacy Shahid Beheshti University of Medical Sciences Tehran IranInfectious Diseases and Tropical Medicine Research Center Shahid Beheshti University of Medical Sciences, Tehran, Iran Tehran IranDepartment of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Orthopedic Surgery, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Radiology, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranInfectious Diseases and Tropical Medicine Research Center Shahid Beheshti University of Medical Sciences, Tehran, Iran Tehran IranInfectious Diseases and Tropical Medicine Research Center Shahid Beheshti University of Medical Sciences, Tehran, Iran Tehran IranInfectious Diseases and Tropical Medicine Research Center Shahid Beheshti University of Medical Sciences, Tehran, Iran Tehran IranDepartment of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Pulmonary and Critical Care Medicine, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Internal Medicine, Emam Hossein Medical Center Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Clinical Pharmacy, Faculty of Pharmacy Shahid Beheshti University of Medical Sciences Tehran IranDepartment of Clinical Pharmacy, Faculty of Pharmacy Tehran University of Medical Sciences Tehran IranDepartment of Clinical Pharmacy, Faculty of Pharmacy Shahid Beheshti University of Medical Sciences Tehran IranMedical Biotechnology Department, Biotechnology Research Center Pasteur Institute of Iran Tehran IranPersisGen Par Company Alborz IranDepartment of Microbiology, Faculty of Advanced Science and Technology, Tehran Medical Sciences Islamic Azad University Tehran IranAbstract 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.https://doi.org/10.1002/iid3.563acute respiratory distress syndromeanakinracoronavirusCOVID‐19inflammationinterleukin‐1 inhibitor |
| spellingShingle | Amir Behnam Kharazmi Omid Moradi Mehrdad Haghighi Mehran Kouchek Alireza Manafi‐Rasi Masoomeh Raoufi Simin Dokht Shoaei Fahimeh Hadavand Mahmood Nabavi Mir Mohammad Miri Sara Salarian Seyedpouzhia Shojaei Shayesteh Khalili Mohammad Sistanizad Setayesh Sadeghi Amirhossein Karagah Saemeh Asgari Morteza Jaffaraghaei Shahram Araghi A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19 Immunity, Inflammation and Disease acute respiratory distress syndrome anakinra coronavirus COVID‐19 inflammation interleukin‐1 inhibitor |
| title | A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19 |
| title_full | A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19 |
| title_fullStr | A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19 |
| title_full_unstemmed | A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19 |
| title_short | A randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe COVID‐19 |
| title_sort | randomized controlled clinical trial on efficacy and safety of anakinra in patients with severe covid 19 |
| topic | acute respiratory distress syndrome anakinra coronavirus COVID‐19 inflammation interleukin‐1 inhibitor |
| url | https://doi.org/10.1002/iid3.563 |
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