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
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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