Promising Effects of Tocilizumab in COVID-19: A Non-Controlled, Prospective Clinical Trial
Autor: | Seyed Mohammadreza Hashemian, Jalal Heshmatnia, Mihan Pourabdollah Toutkaboni, Payam Tabarsi, Sahar Yousefian, Sara Haseli, Farzaneh Dastan, Hamidreza Jammati, Alireza Dastan, Mohsen Sadeghi, Arda Kiani, Ali Saffaei, Parvaneh Baghaei, Jamshid Salamzadeh, Mohammad Varahram, Zahra Abtahian, Seyed Alireza Nadji, Sharareh Seifi, Alireza Eslaminejad, Majid Marjani, Afshin Moniri, Atefeh Abedini |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
0301 basic medicine
Male medicine.medical_treatment Interleukin 6 Kaplan-Meier Estimate Severity of Illness Index chemistry.chemical_compound 0302 clinical medicine Immunology and Allergy Medicine Prospective Studies Stage (cooking) Prospective cohort study Infusions Intravenous skin and connective tissue diseases Lung Middle Aged Tocilizumab 030220 oncology & carcinogenesis Breathing Female Coronavirus Infections medicine.medical_specialty Immunology Pneumonia Viral macromolecular substances Antibodies Monoclonal Humanized Antiviral Agents Article 03 medical and health sciences Betacoronavirus Internal medicine Severity of illness Humans Adverse effect Pandemics Pharmacology Mechanical ventilation business.industry Interleukin-6 SARS-CoV-2 COVID-19 Respiration Artificial Clinical trial Coronavirus 030104 developmental biology chemistry business Tomography X-Ray Computed |
Zdroj: | International Immunopharmacology |
ISSN: | 1878-1705 1567-5769 |
Popis: | Highlights • The pathophysiology of severe SARS-CoV-2 infection may be attributed to cytokine release syndrome. • In this syndrome, inflammatory cytokines (especially interleukin 6) are released after the activation of the inflammatory cascade. • The mortality rate among patients receiving tocilizumab with severe or critical SARS-CoV-2 infection was reported 16% in the current study comparing to 49 % based on the recent studies. • Tocilizumab, as an interleukin 6 antagonist, may be a promising agent to decrease the mortality rate in severe or critical SARS-CoV-2 infection. Background The 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. Methods In 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. Results Of 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. Conclusions Based 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. |
Databáze: | OpenAIRE |
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