6/28/23, 12:17 AM COV-BARRIER Pathway Feedback Search Clinical Topics Home Studies COV BARRIER COV BARRIER Disease COVID 19 infection Trial question What is the role of baricitinib in critically ill hospitalized patients with COVID-19 requiring invasive mechanical ventilation or ECMO? Study design Multi-center Double blinded RCT Population Characteristics of study participants 46.0% female N = 101 54.0% male 101 patients (46 female, 55 male) Inclusion criteria: adults hospitalized with COVID-19 on invasive mechanical ventilation or ECMO Key exclusion criteria: receipt of high-dose corticosteroids in the month before study entry; receipt of convalescent plasma or IVIG for COVID-19; suspected serious active bacterial, fungal, or other infection Interventions N=51 baricitinib (oral dose of 4 mg plus standard of care) N=50 placebo (oral dose of matching placebo plus standard of care) Primary outcome Death from all causes at day 28 58.0 % 58 https://web.pathway.md/studies/recpgDg5YTjalzY7B 1/2 6/28/23, 12:17 AM COV-BARRIER Pathway 43.5 % 39 29.0 % Significant decrease 14.5 % NNT = 5 0.0 % Baricitinib Placebo Significant decrease in death from all causes at day 28 (39% vs. 58%; HR 0.54, 95% CI 0.31 to 0.96) Secondary outcomes Significant decrease in death from all causes at day 60 (45% vs. 62%; HR 0.56, 95% CI 0.33 to 0.97) No significant difference in ventilator-free days (8.1 days vs. 5.5 days; AD 2.36 days, 95% CI -1.38 to 6.09) Borderline significant decrease in duration of hospitalization (23.7 days vs. 26.1 days; AD -2.3 days, 95% CI -4.59 to 0) Safety outcomes No significant differences in infection, blood clot formation, and adverse cardiovascular events. Conclusion In adults hospitalized with COVID-19 on invasive mechanical ventilation or ECMO, baricitinib was superior to placebo with respect to death from all causes at day 28. Reference E Wesley Ely, Athimalaipet V Ramanan, Cynthia E Kartman et al. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Apr;10(4):327-336. Open reference URL https://web.pathway.md/studies/recpgDg5YTjalzY7B 2/2