COV-BARRIER
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
54.0% male
N = 101
101 patients (46 female, 55 male).
Inclusion criteria: adult patients 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
All-cause mortality at day 28
39%
58%
58.0 %
43.5 %
29.0 %
14.5 %
0.0 %
Baricitinib
Placebo
Significant
decrease ▼
NNT = 5
Significant decrease in all-cause mortality at day 28 (39% vs. 58%; HR 0.54, 95% CI 0.31 to 0.96).
Secondary outcomes
Significant decrease in all-cause mortality 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 CV events.
Conclusion
In adult patients hospitalized with COVID-19 on invasive mechanical ventilation or ECMO, baricitinib was superior to placebo with respect to all-cause mortality 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.
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