Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
An erratum to this article was published (Lancet Diabetes Endocrinol, Jan 2024 ↗)
Primary result · DeathResult — go to the resultRate ratio 0.96 95% CI 0.82–1.13Authors' conclusion
In adults hospitalised with COVID-19, empagliflozin was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death so is not indicated for the treatment of such patients unless there is an established indication due to a different condition such as diabetes.
Study context
- Population
- Adults hospitalised with COVID-19randomised 1:1
- Participants
- 4,271 adults
- Comparison
- Usual care plus empagliflozin 10 mg once daily vs usual care alone
- Empagliflozinn = 2,113
- Usual caren = 2,158reference
- Primary endpoint
- 28-day mortality
- Follow-up
- 28 days
Methodological detailsopen-label, platform trial, Recruitment stopped on March 7, 2023 after the independent data monitoring committee recommended data review
- Open-label
- Platform trial
- Recruitment stopped on March 7, 2023 after the independent data monitoring committee recommended data review
Primary result
Death
Rate ratio
0.96
95% CI 0.82–1.13
P = 0.64
Events by treatment group
Empagliflozinvs Usual care
rate ratio 0.96 (95% CI 0.82–1.13); P = 0.64
As reported in the abstract
Secondary outcomes
Duration of hospitalisation
| Outcome | Empagliflozin | Usual care | Estimate | P value | |
|---|---|---|---|---|---|
| Discharged alive · 28 days | 79% | 78% | rate ratio 1.03 (95% CI 0.96–1.10) | P = 0.44 | |
| Invasive mechanical ventilation or death (not on invasive mechanical ventilation at baseline) | 16% | 17% | risk ratio 0.95 (95% CI 0.84–1.08) | P = 0.44 | |
| 0.512Ratio (log scale) |
- Invasive mechanical ventilation or death (not on invasive mechanical ventilation at baseline): 2084 vs 2143 at risk
Duration of hospitalisation
- No evidence of significant difference
Safety
- Serious adverse events believed related to empagliflozin, both ketosis without acidosis
- 2
Original publication
Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Diabetes Endocrinol. Published 18 October 2023. doi:10.
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