6/30/23, 2:17 AM TOCIBRAS Pathway Feedback Search Clinical Topics Home Studies TOCIBRAS TOCIBRAS Disease COVID 19 infection Trial question What is the role of tocilizumab in patients with severe or critical COVID-19 infection? Study design Multi-center Open label RCT Population Characteristics of study participants 32.0% female N = 129 68.0% male 129 patients (41 female, 88 male) Inclusion criteria: adult patients with COVID-19 infection who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (CRP, D- dimer, LDH, or ferritin) Key exclusion criteria: hypersensitivity to tocilizumab, active uncontrolled infections, low neutrophils count, low platelets count, liver disease, cirrhosis or elevated AST or ALT above 5 times the upper limit, renal disease with estimate glomerular filtration below 30 mL/min/1.72 m , active diverticulitis Interventions N=65 tocilizumab (single intravenous infusion of 8 mg/kg plus standard care) N=64 standard of care (standard care alone) https://web.pathway.md/studies/recjZNcO4EdpvPfbp 1/2 6/30/23, 2:17 AM TOCIBRAS Pathway Primary outcome Death or mechanical ventilation at 15 days 28.0 % 28 21.0 % 20 14.0 % 7.0 % No significant difference 0.0 % Tocilizumab Standard of care No significant difference in death or mechanical ventilation at 15 days (28% vs. 20%; OR 1.54, 95% CI 0.66 to 3.66) Secondary outcomes No significant difference in death at 28 days (21% vs. 9%; OR 2.7, 95% CI 0.97 to 8.35) Significant increase in death in the hospital (21% vs. 9%; OR 2.7, 95% CI 0.97 to 8.35) Safety outcomes No significant difference in adverse events (43% vs. 34%) and serious adverse events (16% vs. 11%). Conclusion In adult patients with COVID-19 infection who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (CRP, D-dimer, LDH, or ferritin), tocilizumab was not superior to standard of care with respect to death or mechanical ventilation at 15 days. Reference Viviane C Veiga, Jo o A G G Prats, Danielle L C Farias et al. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial. BMJ. 2021 Jan 20;372:n84. Open reference URL https://web.pathway.md/studies/recjZNcO4EdpvPfbp 2/2