Abstract
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.
【저자키워드】 COVID-19, SARS-CoV-2, coronavirus, Tocilizumab, interleukin 6, 【초록키워드】 Severe infection, IL-6, SARS-COV-2 infection, C-reactive protein, outcome, invasive ventilation, Lungs, Patient, death, Clinical improvement, plasma, Critical, patients, Inflammatory cytokine, single dose, acute respiratory distress, Adverse drug reactions, Invasive mechanical ventilation, dose, Oxygenation, intravenous, IL-6 antagonist, Support, Prospective clinical trial, adverse effect, Activation, Mild symptom, median age, syndrome, SPSS software, eligibility, tocilizumab administration, severe complications, Administered, inflammatory cascade, secondary, radiological, Result, analyzed, evaluated, required, changes in, initiated, predominant, released, evaluate the effect, patients died, the median, 【제목키워드】 Prospective clinical trial, Effect,