Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial
Primary result · All-cause mortalityResult — go to the resultAdjusted absolute difference - 0.1 % 95% CI - 8.3 to 8.0- stopped prematurely for external evidence
- Enrolment June 3, 2021 to March 7, 2022; stopped prematurely for external evidence
Authors' conclusion
This clinical trial was prematurely stopped for external evidence and therefore underpowered to conclude on a potential survival benefit of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities.
Study context
- Population
- Hospitalised adults with severe/critical COVID-19275 in modified ITT analysis
- Participants
- 284 adults
- Comparison
- Baricitinib 4 mg once daily vs placebo, added to standard of care
- Baricitinibn = 139
- Placebon = 136reference
- Primary endpoint
- All-cause mortality
- Follow-up
- 60 days
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Adjusted absolute difference
- 0.1 %
95% CI - 8.3 to 8.0
Events by treatment group
Further findings
Death, sensitivity analysis censoring after drug discontinuation or rescue therapy (tocilizumab/increased steroid dose)
difference (%) - 3.2 (- 9.0 to 2.7)
60-day mortality by vaccination status (subgroup)
- Potential interaction between vaccination status and treatment allocation
Safety
Serious adverse events
Serious adverse events Baricitinib 148 · Placebo 155
Serious adverse events by vaccination status (post hoc)
- Significant interaction between vaccination status and treatment allocation, with more respiratory complications and severe infections in vaccinated participants treated with baricitinib
- Post hoc analysis
- Vaccinated participants on average 11 years older, with more comorbidities
Original publication
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