6/28/23, 12:48 AM ATTKPATRASCOVID19 Pathway Feedback Search Clinical Topics Home Studies ATTKPATRASCOVID19 ATTKPATRASCOVID19 Disease COVID 19 infection Trial question Is baricitinib noninferior to tocilizumab in patients with severe COVID-19 infection? Study design Single center Open label RCT Population Characteristics of study participants 41.0% female N = 251 59.0% male 251 patients (103 female, 148 male) Inclusion criteria: patients with COVID-19 and the ratio of partial pressure of oxygen to FiO2 < 200 Key exclusion criteria: age < 18 years; pregnancy; eGFR < 30 mL/min/1.73 m ; mechanical ventilation prior to randomization Interventions N=125 baricitinib (at a dose of 4 mg/day for up to 14 days or until discharge) N=125 tocilizumab (a single infusion of 8 mg/kg plus standard care) Primary outcome Rate of mechanical ventilation or death by day 28 44.4 44.4 % https://web.pathway.md/studies/reclc4HuFbuI1KWKa 1/2 6/28/23, 12:48 AM 44.4 % ATTKPATRASCOVID19 Pathway 39.2 33.3 % 22.2 % Difference not exceeding nonferiority margin 11.1 % 0.0 % Baricitinib Tocilizumab Difference not exceeding nonferiority margin in the rate of mechanical ventilation or death by day 28 (39.2% vs. 44.4%; HR 0.83, 95% CI 0.56 to 1.21) Secondary outcomes Significant increase in the rate of the percentage of patients who were discharged alive after 28 days (58.4% vs. 52.4%; HR 1.17, 95% CI 0.84 to 1.63) Significant decrease in the rate of death within 28 days (32% vs. 39.7%; HR 0.73, 95% CI 0.49 to 1.09) Safety outcomes No significant difference in 1 adverse event. Significant difference in increased liver transaminases (2.4% vs. 7.9%). Conclusion In patients with COVID-19 and the ratio of partial pressure of oxygen to FiO2 < 200, baricitinib was noninferior to tocilizumab with respect to the rate of mechanical ventilation or death by day 28. Reference Theodoros Karampitsakos, Ourania Papaioannou, Panagiota Tsiri et al. Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial. Clin Microbiol Infect. 2022 Oct 20;S1198-743X(22)00529-8. Open reference URL https://web.pathway.md/studies/reclc4HuFbuI1KWKa 2/2