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

  1. RECOVERY Collaborative Group
  2. Peter W Horby
  3. Guilherme Pessoa-Amorim
  4. Natalie Staplin
  5. Jonathan R Emberson
  6. Mark Campbell
  7. Enti Spata
  8. Leon Peto
  9. Nigel J Brunskill
  10. Simon Tiberi
  11. Victor Chew
  12. Thomas Brown
  13. Hasan Tahir
  14. Beate Ebert
  15. David Chadwick
  16. Tony Whitehouse
  17. Rahuldeb Sarkar
  18. Clive Graham
  19. J Kenneth Baillie
  20. Buddha Basnyat
  21. Maya H Buch
  22. Lucy C Chappell
  23. Jeremy Day
  24. Saul N Faust
  25. Raph L Hamers
  26. Thomas Jaki
  27. Edmund Juszczak
  28. Katie Jeffery
  29. Wei Shen Lim
  30. Alan Montgomery
  31. Andrew Mumford
  32. Kathryn Rowan
  33. Guy Thwaites
  34. Marion Mafham
  35. Richard Haynes
  36. Martin J Landray
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Abstract

Background

Aspirin has been proposed as a treatment for COVID-19 on the basis of its antithrombotic properties.

Methods

In this randomised, controlled, open-label platform trial, several possible treatments were 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 plus 150mg aspirin once daily until discharge or usual standard of care alone using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. The trial is registered with ISRCTN (50189673) and <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">clinicaltrials.gov</ext-link> ( <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04381936">NCT04381936</ext-link> ).

Findings

Between 01 November 2020 and 21 March 2021, 7351 patients were randomly allocated to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) patients allocated to aspirin and 1299 (17%) patients allocated to usual care died within 28 days (rate ratio 0·96; 95% confidence interval [CI] 0·89-1·04; p=0·35). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 vs. 9 days) and a higher proportion were discharged from hospital alive within 28 days (75% vs. 74%; rate ratio 1·06; 95% CI 1·02-1·10; p=0·0062). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0·96; 95% CI 0·90-1·03; p=0·23). Aspirin use was associated with an absolute reduction in thrombotic events of 0.6% (SE 0.4%) and an absolute increase in major bleeding events of 0.6% (SE 0.2%).

Interpretation

In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28-day mortality or in the risk of progressing to invasive mechanical ventilation or death but was associated with a small increase in the rate of being discharged alive within 28 days.

Funding

UK Research and Innovation (Medical Research Council), National Institute of Health Research (Grant ref: MC_PC_19056), and the Wellcome Trust (Grant Ref: 222406/Z/20/Z) through the COVID-19 Therapeutics Accelerator.

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