TY - JOUR
T1 - Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY)
T2 - a randomised, controlled, open-label, platform trial
AU - RECOVERY Collaborative Group
AU - Horby, Peter W
AU - Peto, Leon
AU - Staplin, Natalie
AU - Campbell, Mark
AU - Pessoa-Amorim, Guilherme
AU - Mafham, Marion
AU - Emberson, Jonathan R
AU - Stewart, Richard
AU - Prudon, Benjamin
AU - Uriel, Alison
AU - Green, Christopher A
AU - Dhasmana, Devesh J
AU - Malein, Flora
AU - Majumdar, Jaydip
AU - Collini, Paul
AU - Shurmer, Jack
AU - Yates, Bryan
AU - Baillie, J Kenneth
AU - Buch, Maya H
AU - Day, Jeremy
AU - Faust, Saul N
AU - Jaki, Thomas
AU - Jeffery, Katie
AU - Juszczak, Edmund
AU - Knight, Marian
AU - Lim, Wei Shen
AU - Montgomery, Alan
AU - Mumford, Andrew
AU - Rowan, Kathryn
AU - Thwaites, Guy
AU - Haynes, Richard
AU - Landray, Martin J
N1 - Publisher Copyright:
© 2024, The Author(s).
PY - 2024/1/31
Y1 - 2024/1/31
N2 - 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.
AB - 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.
KW - Adult
KW - Humans
KW - COVID-19
KW - Dimethyl Fumarate/therapeutic use
KW - SARS-CoV-2
KW - Hospitalization
KW - Hospitals
KW - Treatment Outcome
U2 - 10.1038/s41467-023-43644-x
DO - 10.1038/s41467-023-43644-x
M3 - Article (Academic Journal)
C2 - 38296965
SN - 2041-1723
VL - 15
JO - Nature Communications
JF - Nature Communications
M1 - 924
ER -