6/27/23, 11:40 PM BACC Pathway Feedback Search Clinical Topics Home Studies BACC BACC Disease COVID 19 infection Trial question What is the effect of tocilizumab in moderately ill patients hospitalized with COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 42.0% female N = 243 58.0% male 243 patients (102 female, 141 male) Inclusion criteria: patients with confirmed SARS-CoV-2 infection, hyperinflammatory states, and at least two of the following signs: fever, pulmonary infiltrates, or the need for supplemental oxygen in order to maintain oxygen saturation > 92% Key exclusion criteria: receipt of supplemental oxygen at a rate > 10 L/min, a recent history of treatment with biologic agents or small-molecule immunosuppressive therapy, receipt of other immunosuppressive therapy that would increase risk of infection, diverticulitis Interventions N=161 tocilizumab (single dose of intravenous 8 mg per kg of body weight, not exceeding 800 mg plus standard care) N=82 placebo (a matching single dose of intravenous placebo plus standard care) Primary outcome Intubation or death at day 28 https://web.pathway.md/studies/recyPBsALjcNb2NTY 1/2 6/27/23, 11:40 PM BACC Pathway 12.5 % 12.5 10.6 9.4 % 6.3 % 3.1 % No significant difference 0.0 % Tocilizumab Placebo No significant difference in intubation or death at day 28 (10.6% vs. 12.5%; HR 0.83, 95% CI 0.38 to 1.81) Secondary outcomes No significant difference in clinical worsening of disease at 28 days (19.3% vs. 17.4%; HR 1.11, 95% CI 0.59 to 2.1) No significant difference in median time to discontinuation of supplemental oxygen by 28 days (5 days vs. 4.9 days; HR 0.94, 95% CI 0.67 to 1.3) No significant difference in mechanical ventilation (6.8% vs. 9.8%; HR 0.65, 95% CI 0.26 to 1.62) Safety outcomes No significant differences in death, myocardial infarction, thrombocytopenia, bleeding, stroke, seizure, PE or deep vein thrombosis. Significant differences in serious infections (8.1% vs. 17.1%), severe neutropenia (13.7% vs. 1.2%). Conclusion In patients with confirmed SARS-CoV-2 infection, hyperinflammatory states, and at least two of the following signs: fever, pulmonary infiltrates, or the need for supplemental oxygen in order to maintain oxygen saturation > 92%, tocilizumab was not superior to placebo with respect to intubation or death at day 28. Reference John H Stone, Matthew J Frigault, Naomi J Serling-Boyd et al. Efficacy of Tocilizumab in Patients Hospitalized with Covid-19. N Engl J Med. 2020 Dec 10;383(24):2333-2344. Open reference URL https://web.pathway.md/studies/recyPBsALjcNb2NTY 2/2