Nature Communications (Jan 2024)

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

  • RECOVERY Collaborative Group,
  • Peter W. Horby,
  • Leon Peto,
  • Natalie Staplin,
  • Mark Campbell,
  • Guilherme Pessoa-Amorim,
  • Marion Mafham,
  • Jonathan R. Emberson,
  • Richard Stewart,
  • Benjamin Prudon,
  • Alison Uriel,
  • Christopher A. Green,
  • Devesh J. Dhasmana,
  • Flora Malein,
  • Jaydip Majumdar,
  • Paul Collini,
  • Jack Shurmer,
  • Bryan Yates,
  • J. Kenneth Baillie,
  • Maya H. Buch,
  • Jeremy Day,
  • Saul N. Faust,
  • Thomas Jaki,
  • Katie Jeffery,
  • Edmund Juszczak,
  • Marian Knight,
  • Wei Shen Lim,
  • Alan Montgomery,
  • Andrew Mumford,
  • Kathryn Rowan,
  • Guy Thwaites,
  • Richard Haynes,
  • Martin J. Landray

DOI
https://doi.org/10.1038/s41467-023-43644-x
Journal volume & issue
Vol. 15, no. 1
pp. 1 – 13

Abstract

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Abstract Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome.