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

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Title: Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Authors: Horby, PW
Roddick, A
Spata, E
Staplin, N
Emberson, J
Pessoa-Amorim, G
Brightling, C
Prudon, B
Chadwick, D
Ustianowski, A
Ashish, A
Todd, S
Yates, B
Buttery, R
Scott, S
Maseda, D
Baillie, JK
Buch, M
Chappell, L
Day, J
Faust, SN
Jaki, T
Jeffery, K
Juszczak, E
Lim, WS
Montgomery, A
Mumford, A
Rowan, K
Thwaites, G
Mafham, M
Haynes, R
Landray, MJ
Horby, PW
Landray, MJ
Baillie, JK
Buch, M
Chappell, L
Day, J
Faust, SN
Haynes, R
Jaki, T
Jeffery, K
Juszczak, E
Lim, WS
Mafham, M
Montgomery, A
Mumford, A
Rowan, K
Thwaites, G
Sandercock, P
Darbyshire, J
DeMets, D
Fowler, R
Lalloo, D
Roberts, I
Wittes, J
Horby, P
Landray, MJ
Haynes, R
Fletcher, L
Barton, J
Basoglu, A
Brown, R
Brudlo, W
Denis, E
Howard, S
McChlery, G
Taylor, K
Cui, G
Goodenough, B
King, A
Lay, M
Murray, D
Stevens, W
Wallendszus, K
Welsh, R
Crichton, C
Davies, J
Goldacre, R
Harper, C
Knight, F
Latham-Mollart, J
Mafham, M
Nunn, M
Salih, H
Welch, J
Campbell, M
Pessoa-Amorim, G
Peto, L
Roddick, A
Knott, C
Wiles, J
Bell, JL
Emberson, J
Juszczak, E
Linsell, L
Spata, E
Staplin, N
Bagley, G
Cameron, S
Chamberlain, S
Farrell, B
Freeman, H
Kennedy, A
Whitehouse, A
Wilkinson, S
Wood, C
Reith, C
Davies, K
Halls, H
Holland, L
Wilson, K
Howie, L
Lunn, M
Rodgers, P
Barnard, A
Beety, J
Birch, C
Brend, M
Chambers, E
Chappell, L
Crawshaw, S
Drake, C
Duckles-Leech, H
Graham, J
Harman, T
Harper, H
Lock, S
Lomme, K
McMillan, N
Nickson, I
Ohia, U
OKell, E
Poustie, V
Sam, S
Sharratt, P
Sheffield, J
Slade, H
Hoff, WV
Walker, S
Williamson, J
De Soyza, A
Dimitri, P
Faust, SN
Lemoine, N
Minton, J
Gilmour, K
Pearson, K
Armah, C
Campbell, D
Cate, H
Priest, A
Thomas, E
Usher, R
Johnson, G
Logan, M
Pratt, S
Price, A
Shirley, K
Walton, E
Williams, P
Yelnoorkar, F
Hanson, J
Membrey, H
Gill, L
Oliver, A
Das, S
Murphy, S
Sutu, M
Collins, J
Monaghan, H
Unsworth, A
Beddows, S
Williams, KB
Dowling, S
Gibbons, K
Pine, K
Asghar, A
Aubrey, P
Jewell, DB
Donaldson, K
Skinner, T
Luo, J
Mguni, N
Muzengi, N
Pleass, R
Wayman, E
Coe, A
Hicks, J
Hough, M
Levett, C
Potter, A
Taylor, J
Dolman, M
Gerdes, L
Hall, C
Lockett, T
Wessex, DP
Bartholomew, J
Dowden, L
Rook, C
Walters, J
Denton, E
Tinkler, H
Alexander, A
Campbell, H
Chapman, K
Hall, A
Rodgers, A
Boyle, P
Brookes, M
Callens, C
Duffy, H
Green, C
Hampshire, K
Harrison, S
Kirk, J
Naz, M
Porter, L
Ryan, P
Shenton, J
Warmington, J
Amezaga, M
Dicks, P
Goodwin, J
Hodgson, H
Jackson, S
Odam, M
Williamson, D
Faust, SN
Bamford, A
Bandi, S
Bernatoniene, J
Cathie, K
Dmitri, P
Drysdale, S
Emonts, M
Evans, J
Finn, A
Fleming, P
Furness, J
Gale, C
Haynes, R
Jones, CE
Juszczak, E
Jyotish, D
Kelly, D
Murray, C
Pathan, N
Pollock, L
Ramanan, A
Riordan, A
Roehr, C
Wan, M
Whittaker, E
Chappell, L
Hodson, K
Knight, M
Pavord, S
Williamson, C
Odam, M
Black, P
Gallagher, B
MacInnes, L
O'Brien, R
Priestley, K
Saunderson, A
Bowman, L
Chen, F
Clarke, R
Goonasekara, M
Haynes, R
Herrington, W
Judge, P
Mafham, M
Ng, S
Preiss, D
Reith, C
Sammons, E
Zhu, D
Pinches, H
Bowker, P
Byrne-Watts, V
Chapman, G
Coleman, G
Gray, J
Rees, A
Landray, MJ
Mafham, M
Mather, N
Stephenson, C
Denwood, T
Harrison, D
Turner, G
Bruce, J
Arkley, C
Rees, S
Brightling, C
Brunskill, N
Wiselka, M
Adenwalla, S
Andreou, P
Bakoulas, P
Bandi, S
Batham, S
Beaver, T
Bhandal, K
Bourne, M
Boyles, L
Cannon, M
Charalambou, A
Cheung, CK
Cotter, R
Diver, S
Dunphy, A
Elneima, O
Fawke, J
Finch, J
Gardiner-Hill, C
Genato, G
Graham-Brown, M
Haines, C
Hargadon, B
Holdsworth, H
Ibrahim, W
Ingram, L
Silva, JAJ
Kaul, K
Joshi, M
Kapoor, S
Kim, JW
Kuverji, A
Kyriaki, K
Lea, A
Lee, T
Lewszuk, A
Lock, L
Macconaill, K
Major, R
McAuley, H
McCourt, P
Kutten, DM
Palfreeman, A
Parker, E
Patel, K
Patterson, M
Phillips, R
Plummer, L
Russell, R
Debbie, S
Selvaskandan, H
Southin, SM
Tsilimpari, KK
Wiesender, C
Yousuf, A
Ustianowski, A
Raw, J
Tully, R
Abdusamad, K
Antonina, Z
Ayaz, E
Blackledge, B
Bradley, P
Bray, F
Bruce, M
Carty, C
Charles, B
Connolly, G
Corbett, C
Dermody, S
Durrans, L
Falconer, E
Flaherty, J
Fox, C
Hadfield, D
Harris, J
Hoggett, L
Horsley, A
Hussain, S
Irving, R
Jacob, P
Johnstone, D
Joseph, R
Melville, JJ
Kamath, P
Khatun, T
Lamb, T
Law, H
Lazo, M
Lindergard, G
Lokanathan, S
Macfarlane, L
Mathen, S
McCullough, S
McMaster, P
McSorland, D
Mishra, B
Munt, S
Neal, A
Newport, R
O'Connor, G
O'Riordan, D
Page, I
Parambil, V
Philbin, J
Pinjala, MT
Rishton, C
Riste, M
Rothwell, J
Sam, M
Sarwar, Z
Scarratt, L
Sengupta, A
Sharaf, H
Prudon, B
Jagannathan, V
Adams, C
Aung, N
Barker, D
Campbell, B
Collins, V
Deane, J
Fenner, I
Gowans, S
Hartrey, W
Nafei, M
Poole, L
Purvi, S
Quigley, J
Ramshaw, A
Shepherd, L
Skelton, J
Srinivasan, R
Taylor, R
Walker, M
Weetman, M
Wetherall, B
Wild, S
Wilson, D
Lim, WS
Ali, M
Andrews, A
Anderson, L
Ashraf, S
Ashton, D
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Bartlett, G
Batra, D
Bendall, L
Benetti, N
Brear, T
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Fatemi, A
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Hallas, J
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Item Type: Journal Article
Abstract: Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24). Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication. Funding UK Research and Innovation (Medical Research Council) and National Institute of Health Research.
Issue Date: 13-Feb-2021
Date of Acceptance: 1-Feb-2021
URI: http://hdl.handle.net/10044/1/86993
DOI: 10.1016/S0140-6736(21)00149-5
ISSN: 0140-6736
Publisher: Elsevier
Start Page: 605
End Page: 612
Journal / Book Title: The Lancet
Volume: 397
Issue: 10274
Copyright Statement: © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
Sponsor/Funder: National Institute for Health Research
UK Research and Innovation
Funder's Grant Number: RP-2016-07-012
9815274 MC_PC_19025
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
Azithromycin
COVID-19
Female
Hospital Mortality
Hospitalization
Humans
Length of Stay
Male
Middle Aged
Survival Rate
Treatment Outcome
United Kingdom
RECOVERY Collaborative Group
Humans
Azithromycin
Treatment Outcome
Hospitalization
Length of Stay
Hospital Mortality
Survival Rate
Middle Aged
Female
Male
United Kingdom
COVID-19
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
11 Medical and Health Sciences
General & Internal Medicine
Publication Status: Published
Online Publication Date: 2021-02-02
Appears in Collections:Bioengineering
Department of Surgery and Cancer
Department of Infectious Diseases
National Heart and Lung Institute
Faculty of Medicine
Imperial College London COVID-19



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