What is the full potential of baricitinib in treating patients with COVID-19?

Figures & data

Figure 1. A summary of the proposed anti-inflammatory and anti-viral actions of baricitinib in the treatment of COVID-19.

Table 1. A summary of the RCTs investigating the efficacy of baricitinib in the management of adult inpatients with COVID-19. The table outlines differences in size, recruitment period, standard of care (SOC) therapies, primary outcomes, and AEs between trials. Note that RCTs investigating other JAK inhibitors were excluded from this summary

RCT	Number of participants	Enrollment period	SOC therapy in enrolled patients	Primary endpoint	Primary outcome	28-day mortality	AEs
ACTT-2[13] NCT04401579	1033	May 2020 – July 2021	100% remdesivir Excluded corticosteroids and IL-6 inhibitors	Time to recovery	Median time to recovery 7 days in baricitinib arm vs. 8 days in placebo arm (p = 0.03)	HR 0.65 in baricitinib vs. placebo arm (95% CI: 0.39 to 1.09)	SAEs less frequent in the baricitinib group
COV−BARRIER[8] NCT04421027	1525	Jun 2020-Jan 2021	91% corticosteroids 19% remdesivir Excluded IL-6 inhibitors	Proportion who progressed to high-flow oxygen, NIV, invasive mechanical ventilation, or death by day 28	27 · 8% in baricitinib arm vs. 30 · 5% in placebo arm progressed to the primary endpoint (OR 0 · 85 [95% CI 0 · 67 to 1 · 08])	HR 0 · 57 in baricitinib vs. placebo arm (95% CI 0 · 41–0 · 78)	No difference in SAEs between two groups
COV−BARRIER (critically -ill)[15]NCT04421027	101	Dec 2020 – April 2021	86% corticosteroids Excluded IL-6 inhibitors	28-day all-cause mortality	HR 0 · 54 in baricitinib vs. placebo arm (95% CI: 0 · 31–0 · 96; p = 0 · 030) 46% relative reduction and 19% absolute risk reduction in mortality in baricitinib arm		No difference in SAEs between two groups
RECOVERY[14] NCT04381936	8156	Feb 2021 – Dec 2021	95% corticosteroids 23% tocilizumab 21% remdesivir 11% casirivimab -imdevimab	28-day all-cause mortality	Age-adjusted mortality rate 0 · 87 in baricitinib vs. placebo arm (95% CI 0 · 77–0 · 98; p = 0 · 026)		Reduction in new onset cardiac arrhythmia in baricitinib group. No other differences between arms

HR: Hazard ratio, OR: Odds ratio, AE: Adverse events, SAE: Serious adverse events, SOC: Standard of care, RCT: Randomized control trial

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