• Farzaneh Dastan, Ali Saffaei, Sara Haseli, Majid Marjani, Afshin Moniri, Zahra Abtahian, Atefeh Abedini, Arda Kiani, Sharareh Seifi, Hamidreza Jammati, Hashemian Seyed Mohammad Reza SMR Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beh, Mihan Pourabdollah Toutkaboni, Alireza Eslaminejad, Jalal Heshmatnia, Mohsen Sadeghi, Seyed Alireza Nadji, Alireza Dastan, Parvaneh Baghaei, Mohammad Varahram, Sahar Yousefian, Jamshid Salamzadeh, and Payam Tabarsi.
• Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
• Int. Immunopharmacol. 2020 Nov 1; 88: 106869.

BackgroundThe clinical presentation of SARS-CoV-2 infection ranges from mild symptoms to severe complications, including acute respiratory distress syndrome. In this syndrome, inflammatory cytokines are released after activation of the inflammatory cascade, with the predominant role of interleukin (IL)-6. The aim of this study was to evaluate the effects of tocilizumab, as an IL-6 antagonist, in patients with severe or critical SARS-CoV-2 infection.MethodsIn this prospective clinical trial, 76 patients with severe or critical SARS-CoV-2 infection were evaluated for eligibility, and ultimately, 42 patients were included. Tocilizumab was administered at a dose of 400 mg as a single dose via intravenous infusion. Primary outcomes included changes in oxygenation support, need for invasive mechanical ventilation, and death. Secondary outcomes included radiological changes in the lungs, IL-6 plasma levels, C-reactive protein levels, and adverse drug reactions. The data were analyzed using SPSS software.ResultsOf the 42 included patients, 20 (48%) patients presented the severe infection stage and 22 (52%) were in the critical stage. The median age of patients was 56 years, and the median IL-6 level was 28.55 pg/mL. After tocilizumab administration, only 6 patients (14%) required invasive ventilation. Additionally, 35 patients (83.33%) showed clinical improvement. By day 28, a total of 7 patients died (6 patients in the critical stage and 1 patient in the severe stage). Neurological adverse effects were observed in 3 patients.ConclusionsBased on the current results, tocilizumab may be a promising agent for patients with severe or critical SARS-CoV-2 infection, if promptly initiated during the severe stage.Copyright © 2020 Elsevier B.V. All rights reserved.

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