Effect of sodium–glucose co-transporter-2 inhibitors on survival free of organ support in patients hospitalised for COVID-19 (ACTIV-4a): a pragmatic, multicentre, open-label, randomised, controlled, platform trial
Primary result · Organ support-free daysResult — go to the resultAdjusted odds ratio 0.74 95% CrI 0.48–1.13- stopped early for futility
- Enrolment stopped prematurely for futility on DSMB recommendation (March 31, 2023)
Authors' conclusion
SGLT2 inhibitors did not significantly increase days free of organ support or reduce mortality in patients hospitalised with COVID-19. SGLT2 inhibitors were well tolerated with no observed safety concerns. Overall, these findings do not support the use of SGLT2 inhibitors as standard care in patients hospitalised with COVID-19.
Study context
- Population
- Patients aged ≥18 years hospitalised for COVID-19 (moderate or severe illness), 63 sites in the USA, Spain, Brazil, Italy and Mexico; mean age 72 years, 42% female573 with known 21-day outcome
- Participants
- 575 patients
- Comparison
- SGLT2 inhibitor plus standard of care vs standard of care
- SGLT2 inhibitor + standard of caren = 285
- Standard of caren = 288reference
- Primary endpoint
- Organ support-free days
- Follow-up
- Through 21 days
Methodological detailspragmatic, multicentre, open-label, platform trial
- Pragmatic
- Multicentre
- Open-label
- Platform trial
Primary result
As reported in the abstract
21 days
Adjusted odds ratio
0.74
95% CrI 0.48–1.13
Events by treatment group
SGLT2 inhibitor + standard of carevs Standard of care
adjusted OR 0.74 (95% CrI 0.48–1.13)
Further findings
| Outcome | SGLT2 inhibitor + standard of care | Standard of care | HR (95% CrI) | |
|---|---|---|---|---|
| Death · 90 daysCrI; probability of HR <1 of 66% | 13% | 15% | 0.91 (0.58–1.43) | |
| 0.512Hazard ratio (log scale) |
Safety
- Ketoacidosis cases
- 0
- No safety concerns observed with SGLT2 inhibitors
Original publication
Effect of sodium–glucose co-transporter-2 inhibitors on survival free of organ support in patients hospitalised for COVID-19 (ACTIV-4a): a pragmatic, multicentre, open-label, randomised, controlled, platform trial. Lancet Diabetes Endocrinol. Published 6 September 2024. doi:10.
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