Subcutaneous tocilizumab in adults with severe and critical COVID-19: A prospective open-label uncontrolled multicenter trial |
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| Affiliation: | 1. Digestive Disease Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran;2. Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran;3. Department of Infectious Disease, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran;4. Neuroscience Research Center, Qom University of Medical Sciences, Qom, Iran;5. Department of Infectious Diseases, School of Medicine, Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran;6. Department of Pulmonology, Rasool-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran;7. Department of Infectious Diseases, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran;8. Department of Internal Medicine, Semnan University of Medical Sciences, Semnan, Iran;9. Antimicrobial Resistance Research Center, Iran University of Medical Sciences, Tehran, Iran;10. Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran;11. Department of Infectious Disease, Tehran University of Medical Sciences, Tehran, Iran;12. Isabn-e-Maryam Hospital, Isfahan University of Medical Sciences, Isfahan, Iran;13. Department of Infectious Disease, Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran;14. Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran;15. Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran;p. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran;q. Medical Department, Orchid Pharmed Company, Tehran, Iran |
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| Abstract: | Potential therapeutic approaches in coronavirus disease 2019 (COVID-19) comprise antiviral and immunomodulatory agents; however, no immunomodulator drug has been approved. This multicenter, prospective, open-label, uncontrolled study aimed to assess the use of subcutaneous tocilizumab in adult patients with severe and critical COVID-19. Tocilizumab was added to the standard care of therapy at a dose of 324 mg (<100 kg bodyweight) or 486 mg (≥100 kg bodyweight). The study endpoints were all-cause mortality rate, changes in oxygen-support level, oxygen saturation, body temperature, respiratory rate, and laboratory variables during the study, and drug safety. Of 126 patients enrolled, 86 had severe and 40 had critical disease. Most patients were male (63.49%) and aged below 65 (78.57%). By day 14 of the study, 4.65% (4/86) of severe patients and 50.00% (20/40) of critical patients died. By the end, 6.98% (6/86) of severe patients and 60.00% (24/40) of critical patients died. Outcomes concerning three additional endpoints (oral temperature, oxygen saturation, and respiratory rate) were significantly improved as early as three days after tocilizumab administration in both groups of subjects, more considerably in severe patients. Significant improvement in the required level of oxygenation was reported in severe patients seven days after tocilizumab administration. No tocilizumab-related serious adverse event occurred in this study. Subcutaneous tocilizumab might improve some clinical parameters and reduce the risk of death in COVID-19 patients, particularly if used in the early stages of respiratory failure. |
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| Keywords: | Tocilizumab COVID-19 COVID-19 pandemic Coronavirus Interleukin 6 Multicenter trial |
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