6/28/23, 9:56 PM EMPACTA Pathway Feedback Search Clinical Topics Home Studies EMPACTA EMPACTA Disease COVID 19 infection Trial question What is the role of tocilizumab in patients hospitalized with COVID-19 pneumonia not undergoing mechanical ventilation? Study design Multi-center Double blinded RCT Population Characteristics of study participants 41.2% female N = 389 58.8% male 389 patients (154 female, 223 male) Inclusion criteria: patients hospitalized with COVID-19 pneumonia who were not receiving mechanical ventilation Key exclusion criteria: receiving CPAP, bilevel positive airway pressure, or mechanical ventilation; progression of the illness to death imminent and inevitable within 24 hours; active tuberculosis or suspected active bacterial, fungal, or viral infection (other than SARS-CoV-2 infection or well-controlled human immunodeficiency virus infection) Interventions N=249 tocilizumab plus standard care (one or two doses of intravenous 8 mg/kg of body weight, to a maximum of 800 mg per dose) N=128 placebo plus standard care (matching one or two intravenous doses of placebo) Primary outcome https://web.pathway.md/studies/recraHR8fi1ToHRg7 1/2 6/28/23, 9:56 PM EMPACTA Pathway Rate of mechanical ventilation or death by day 28 19.3 % 19.3 14.5 % 12 9.7 % Significant decrease 4.8 % NNT = 14 0.0 % Tocilizumab plus standard care Placebo plus standard care Significant decrease in the rate of mechanical ventilation or death by day 28 (12% vs. 19.3%; HR 0.56, 95% CI 0.33 to 0.97) Secondary outcomes No significant difference in median time to hospital discharge or readiness for discharge over 28- day period (6 days vs. 7.5 days; HR 1.16, 95% CI 0.91 to 1.48) Safety outcomes No significant differences in overall adverse events, death, and progression of illness to category 6 on the seven-category ordinal scale. Significant difference in serious adverse events (15.2% vs. 19.7%) and serious infections (5.2% vs. 7.1%). Conclusion In patients hospitalized with COVID-19 pneumonia who were not receiving mechanical ventilation, tocilizumab plus standard care was superior to placebo plus standard care with respect to the rate of mechanical ventilation or death by day 28. Reference Carlos Salama, Jian Han, Linda Yau et al. Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021 Jan 7;384(1):20-30. Open reference URL https://web.pathway.md/studies/recraHR8fi1ToHRg7 2/2