Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Peter Sandercock, Janet Darbyshire, David Demets, Robert Fowler, David Lalloo, Mohammed Munavvar, Adilia Warris, Janet Wittes, A Cradduck-Bamford, J Barton, A Basoglu, R Brown, W Brudlo, E Denis, L Fletcher, S Howard, K Taylor, G Cui, B Goodenough, A King, M Lay, D Murray, W Stevens, K Wallendszus, R Wels, C Crichton, J Davies, R Goldacre, C Harper, F Knight, M Nunn, H Salih, J Welch, M Zayed, J Wiles, G Bagley, S Cameron, S Chamberlain, B Farrell, H Freeman, A Kennedy, A Whitehouse, S Wilkinson, C Wood, C Reith, K Davies, H Halls, L Holland, R Truell, K Wilson, L Howie, M Lunn, P Rodgers, L Bowman, F Chen, R Clarke, M Goonasekara, W Herrington, P Judge, S Ng, D Preiss, E Sammons, D Zhu, A Barnard, J Beety, C Birch, M Brend, E Chambers, L Chappell, S Crawshaw, C Drake, H Duckles-Leech, J Graham, T Harman, H Harper, S Lock, K Lomme, N Mcmillan, I Nickson, U Ohia, E Okell, V Poustie, S Sam, P Sharratt, J Sheffield, H Slade, W Van’t Hoff, S Walker, J Williamson, A De Soyza, P Dimitri, Saul N Faust, N Lemoine, J Minton, K Gilmour, K Pearson, C Armah, D Campbell, H Cate, A Priest, E Thomas, R Usher, G Johnson, M Logan, S Pratt, A Price, K Shirley, E Walton, P Williams, F Yelnoorkar, J Hanson, H Membrey, L Gill, A Oliver, S Das, S Murphy, M Sutu, J Collins, H Monaghan, A Unsworth, S Beddows, K Barker-Williams, S Dowling, K Gibbons, K Pine, A Asghar, P Aubrey, D Beaumont-Jewell, K Donaldson, T Skinner, J Luo, N Mguni, N Muzengi, R Pleass, E Wayman, A Coe, J Hicks, M Hough, C Levett, A Potter, J Taylor, M Dolman, L Gerdes, C Hall, T Lockett, D Porter, J Bartholomew, L Dowden, C Rook, J Walters, E Denton, H Tinkler, A Alexander, H Campbell, K Chapman, A Hall, A Rodgers, P Boyle, M Brookes, C Callens, H Duffy, Christopher A Green, K Hampshire, S Harrison, J Kirk, M Naz, L Porter, P Ryan, J Shenton, J Warmington, M Amezaga, P Dicks, J Goodwin, H Hodgson, S Jackson, M Odam, D Williamson, H Pinches, P Bowker, V Byrne-Watts, G Chapman, G Coleman, J Gray, A Rees, N Mather, T Denwood, D Harrison, G Turner, J Bruce, C Arkley, S Rees, J Alin, L Anguvaa, J Bae, G Bega, S Bowman, A Chakraborty, E Clare, S Fox, S Franklin, S George, L How, M Kennedy, J Mead, L Mew, D Mital, L Moran, E Mwaura, M Nathvani, A Rose, D Scaletta, S Shah, L Siamia, O Spring, S Sutherland, F Teasdale, S Velankar, L Wren, F Wright, M Abouzaid, C Adams, A Al Aaraj, O Alhabsha, M Ali, E Aliberti, D Ashley, D Barker, H Bashir, B Campbell, A Chilvers, E Chinonso, V Collins, E Connell, K Conroy, E Cox, J Deane, J Dunleavy, I Fenner, C Gan, I Garg, C Gibb, S Gowans, W Hartrey, F Hernandez, J Jacob, V Jagannathan, V Jeebun, S Jones, M Khan, Y Koe
Nature Communications, doi:10.1038/s41467-023-43644-x
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. Severe COVID-19 is characterised by marked inflammation of the lungs, which causes respiratory failure and is usually associated with elevated circulating inflammatory markers such as C-reactive protein (CRP), interleukin 1β (IL-1β), and IL-6 1-4 . This has led to the evaluation of several different kinds of immunomodulation in the treatment of severe COVID-19. Corticosteroids, IL-6 inhibitors, and Janus kinase (JAK) inhibitors have all been found to reduce mortality in hospitalised patients, although the risk of death remains high even when these
Role of the funding source The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. D.M.F. was provided from standard National Health Service stocks. The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Reporting summary Further information on research design is available in the Nature Portfolio Reporting Summary linked to this article.
Author contributions This manuscript was initially drafted by L.P., P.W.H. and M.J.L. All authors contributed to data interpretation and critical review and revision of the manuscript. P.W.H. and M.J.L. vouch for the data and analyses, and for the fidelity of this report to the study protocol and data analysis plan. P.W.H., M.M., J.K.B., M.H.B., J.D., S.N.F., T.J., K.J., E.J., M.K., W.S.L., A.Mo., A.Mu., K.R., G.T., R.H., and M.J.L. designed the trial and study protocol. L.P., M.C., G.P.-A., M.M., R.S., B.P., A.U., C.A.G., D.J.D., F.M., J.M., P.C., J.S., B.Y., and the Data Linkage team at the RECOVERY Coordinating Centre, and the Health Records and Local Clinical Centre staff listed in the Supplementary Information collected the data. N.S. and J.R.E. had access to the study data and did the statistical analysis. PWH and MJL had final responsibility for the decision to submit for publication.
Competing interests The authors have no conflict of interest or financial..
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DOI record:
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"abstract": "<jats:title>Abstract</jats:title><jats:p>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.</jats:p>",
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