Effect of Hydroxychloroquine in Hospitalized Patients with COVID-19: Preliminary results from a multi-centre, randomized, controlled trial

  1. Peter Horby
  2. Marion Mafham
  3. Louise Linsell
  4. Jennifer L Bell
  5. Natalie Staplin
  6. Jonathan R Emberson
  7. Martin Wiselka
  8. Andrew Ustianowski
  9. Einas Elmahi
  10. Benjamin Prudon
  11. Anthony Whitehouse
  12. Timothy Felton
  13. John Williams
  14. Jakki Faccenda
  15. Jonathan Underwood
  16. J Kenneth Baillie
  17. Lucy Chappell
  18. Saul N Faust
  19. Thomas Jaki
  20. Katie Jeffery
  21. Wei Shen Lim
  22. Alan Montgomery
  23. Kathryn Rowan
  24. Joel Tarning
  25. James A Watson
  26. Nicholas J White
  27. Edmund Juszczak
  28. Richard Haynes
  29. Martin J Landray
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Abstract

Background

Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (COVID-19) on the basis of in vitro activity, uncontrolled data, and small randomized studies.

Methods

The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is a randomized, controlled, open-label, platform trial comparing a range of possible treatments with usual care in patients hospitalized with COVID-19. We report the preliminary results for the comparison of hydroxychloroquine vs. usual care alone. The primary outcome was 28-day mortality.

Results

1561 patients randomly allocated to receive hydroxychloroquine were compared with 3155 patients concurrently allocated to usual care. Overall, 418 (26.8%) patients allocated hydroxychloroquine and 788 (25.0%) patients allocated usual care died within 28 days (rate ratio 1.09; 95% confidence interval [CI] 0.96 to 1.23; P=0.18). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to hydroxychloroquine were less likely to be discharged from hospital alive within 28 days (60.3% vs. 62.8%; rate ratio 0.92; 95% CI 0.85-0.99) and those not on invasive mechanical ventilation at baseline were more likely to reach the composite endpoint of invasive mechanical ventilation or death (29.8% vs. 26.5%; risk ratio 1.12; 95% CI 1.01-1.25). There was no excess of new major cardiac arrhythmia.

Conclusions

In patients hospitalized with COVID-19, hydroxychloroquine was not associated with reductions in 28-day mortality but was associated with an increased length of hospital stay and increased risk of progressing to invasive mechanical ventilation or death.

Funding

Medical Research Council and NIHR (Grant ref: MC_PC_19056).

Trial registrations

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> ).

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