1. Baricitinib with usual care was associated with a 13% proportional reduction in mortality compared to treatment as usual care alone.
2. Baricitinib was associated with a higher discharge alive rate and lower progression to mechanical ventilation.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The RECOVERY study has tested multiple promising drug treatments for COVID-19. In this study, RECOVERY assessed baricitinib, a JAK 1-2 inhibitor, in hospitalized patients with suspected or laboratory confirmed COVID-19 for 10 days. The follow-up period was for 28 days or until discharge or death. Baricitinib was found to be associated with a significantly lower mortality rate compared to usual care alone, as well as a higher rate of discharge. Unexpectedly, this 13% proportional reduction of risk was smaller than eight previous trials. Limitations of this study include the open label design and limited follow-up post-discharge. Nonetheless, using these results in an updated meta-analysis, baricitinib has overall been associated with a 20% proportional reduction in mortality (p<0.0001). These results therefore support the use of baricitinib for COVID-19 in hospitalized patients.
In-Depth [randomized controlled trial]: As part of the larger RECOVERY study, this trial evaluated the use of a JAK inhibitor, baricitinib, for the treatment of COVID-19. Eligible patients were greater than age 2 years and had suspected or laboratory confirmed SARS-CoV-2 infection. Enrolled participants were randomized 1:1 to either standard of care alone (n=4008) or standard of care plus baricitinib (n=4148) for 10 days or until discharge. Outcomes were recorded when patients died, were discharged or after 28 days post-randomization. The primary outcome was 28-day all-cause mortality. Follow-up was completed for 99% of patients in both treatment and control groups. Adjusted for age, treatment with baricitinib was associated with a lower mortality rate (rate ratio 0.87, 95% CI 0.77-0.99; p=0.028) compared to treatment as usual. The absolute mortality rate difference was -2% (14% in treatment as usual and 12% in baricitinib group). Discharge rate was also higher in the baricitinib group (1.10, 1.04-1.15). Risk of progression to mechanical ventilation if not on ventilation at baseline was also lowered (0.89, 0.81-0.98). There was no increase in prespecified safety outcomes during the trial.
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