Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

  1. Peter W Horby
  2. Natalie Staplin
  3. Leon Peto
  4. Jonathan R Emberson
  5. Mark Campbell
  6. Guilherme Pessoa-Amorim
  7. Buddha Basnyat
  8. Louise Thwaites
  9. Rogier Van Doorn
  10. Raph L Hamers
  11. Jeremy Nel
  12. John Amuasi
  13. Manisha Rawal
  14. Dipansu Ghosh
  15. Jonathan Douse
  16. Fergus Hamilton
  17. Anthony Kerry
  18. Pinky Thu-Ta
  19. John Widdrington
  20. Chris Green
  21. Purav Desai
  22. Richard Stewart
  23. Nguyen Thanh Phong
  24. J Kenneth Baillie
  25. Maya H Buch
  26. Saul N Faust
  27. Thomas Jaki
  28. Katie Jeffery
  29. Edmund Juszczak
  30. Marian Knight
  31. Wei Shen Lim
  32. Alan Montgomery
  33. Aparna Mukherjee
  34. Andrew Mumford
  35. Kathryn Rowan
  36. Guy Thwaites
  37. Marion Mafham
  38. Richard Haynes
  39. Martin J Landray
  40. RECOVERY Collaborative Group
Read the full article See related articles

Listed in

This article is not in any list yet, why not save it to one of your lists.
Log in to save this article

Abstract

Background

Empagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic and haemodynamic effects.

Methods

In this randomised, controlled, open-label trial, several possible treatments are compared with usual care in patients hospitalised with COVID-19. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus empagliflozin 10mg once daily for 28 days or until discharge using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. On 3 March the independent data monitoring committee recommended that the investigators review the data and recruitment was consequently stopped on 7 March. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov ( NCT04381936 ).

Findings

Between 8 July 2021 and 6 March 2023, 4271 patients were randomly allocated to receive either empagliflozin (2113 patients) or usual care alone (2158 patients). Overall, 289 (14%) patients allocated to empagliflozin and 307 (14%) patients allocated to usual care died within 28 days (rate ratio 0.96; 95% confidence interval [CI] 0.82-1.13; p=0.64). There was no evidence of significant differences in duration of hospitalisation (median 8 days vs. 8 days) or the proportion of patients discharged from hospital alive within 28 days (79% vs. 78%; rate ratio 1.03; 95% CI 0.96-1.10; p=0.44). Among those not on invasive mechanical ventilation at baseline, there was no evidence of a significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (16% vs. 17%; risk ratio 0.95; 95% CI 0.84-1.08; p=0.44).

Interpretation

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.

Funding

UK Research and Innovation (Medical Research Council) and National Institute of Health Research (Grant ref: MC_PC_19056), and Wellcome Trust (Grant Ref: 222406/Z/20/Z).

Trial registration

ClinicalTrials.gov NCT04381936 https://clinicaltrials.gov/ct2/show/NCT04381936

ISRCTN50189673 http://www.isrctn.com/ISRCTN50189673

Article activity feed

  1. Version published to 10.1101/2023.04.13.23288469v1 on medRxiv