The University of Southampton
University of Southampton Institutional Repository

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

Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
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.
0140-6736
605-612
Ahmed, Muhammad S.
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Akhtar, Muhammad N.
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Allen, Sam
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Turner, Victoria
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Walker, Claire
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Wallis, Louise
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Walters, Jocelyn
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Ward, Deborah
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White, Christopher
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White, James
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Wignall, Christopher
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Williams, Claire
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Williams, Felicity
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Williams, John
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Williams, Karen
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The RECOVERY Collaborative Group
Ahmed, Muhammad S.
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Akhtar, Muhammad N.
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Allen, Jonathan
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Allen, Sam
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Anderson, Nicola
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Atkinson, John
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Avery, Miriam
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Bagmane, Dinesh
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Baker-Moffatt, Michelle
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Barker, Amy
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Barlow, Richard
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Bartholomew, Jazz
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Bell, Louise
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Brown, Heather
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Brown, Louise
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Brown, Richard
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Brown, Tom
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Bull, Thomas
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Butler, Jo
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Campbell, Amy
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Carter, Jonathan
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Cathie, Katrina
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Chambers, Emma
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Clark, Andrew
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Clark, Charlotte
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Clark, Matthew
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Clark, Thomas
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Clarke, Robert
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Clarke, Samantha
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Collins, Nicola
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Cook, Eloise
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Cooper, Lauren
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Curtis, Jonathan
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Davies, Helen
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Davies, Karen
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Davies, Matthew
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Davies, Simon
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Day, Andrew
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The RECOVERY Collaborative Group (2021) Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet, 397 (10274), 605-612. (doi:10.1016/S0140-6736(21)00149-5).

Record type: 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.

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Published date: 2 February 2021
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Identifiers

Local EPrints ID: 477505
URI: http://eprints.soton.ac.uk/id/eprint/477505
ISSN: 0140-6736
PURE UUID: c634c77d-8824-4f29-81c2-f406ebf17db3
ORCID for Muhammad S. Ahmed: ORCID iD orcid.org/0000-0003-3234-2788
ORCID for John Atkinson: ORCID iD orcid.org/0000-0003-3411-8034
ORCID for Heather Brown: ORCID iD orcid.org/0000-0002-2511-2637
ORCID for Richard Brown: ORCID iD orcid.org/0000-0003-0156-7087
ORCID for Amy Campbell: ORCID iD orcid.org/0000-0003-4111-8286
ORCID for Thomas Clark: ORCID iD orcid.org/0000-0001-6276-7061
ORCID for Saul N. Faust: ORCID iD orcid.org/0000-0003-3410-7642
ORCID for Paul Fleming: ORCID iD orcid.org/0000-0003-3881-6235
ORCID for Mark Johnson: ORCID iD orcid.org/0000-0003-1829-9912
ORCID for Chrissie E. Jones: ORCID iD orcid.org/0000-0003-1523-2368
ORCID for Karen Martin: ORCID iD orcid.org/0000-0002-6362-0501
ORCID for Andrew Smith: ORCID iD orcid.org/0000-0001-7321-4331
ORCID for Hazel Smith: ORCID iD orcid.org/0000-0002-1022-8768
ORCID for Monique Sterrenburg: ORCID iD orcid.org/0000-0001-7283-7764
ORCID for Rebecca Thomas: ORCID iD orcid.org/0000-0002-4061-9727
ORCID for Rhys Thomas: ORCID iD orcid.org/0000-0003-0124-0391

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Date deposited: 07 Jun 2023 16:56
Last modified: 24 May 2024 01:59

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Contributors

Author: Muhammad S. Ahmed ORCID iD
Author: Jonathan Allen
Author: Sam Allen
Author: Nicola Anderson
Author: John Atkinson ORCID iD
Author: Miriam Avery
Author: Dinesh Bagmane
Author: Michelle Baker-Moffatt
Author: Amy Barker
Author: Richard Barlow
Author: Jazz Bartholomew
Author: Louise Bell
Author: Heather Brown ORCID iD
Author: Louise Brown
Author: Richard Brown ORCID iD
Author: Tom Brown
Author: Thomas Bull
Author: Jo Butler
Author: Amy Campbell ORCID iD
Author: Jonathan Carter
Author: Katrina Cathie
Author: Emma Chambers
Author: Andrew Clark
Author: Charlotte Clark
Author: Matthew Clark
Author: Thomas Clark ORCID iD
Author: Robert Clarke
Author: Samantha Clarke
Author: Nicola Collins
Author: Eloise Cook
Author: Lauren Cooper
Author: Jonathan Curtis
Author: Helen Davies
Author: Karen Davies
Author: Matthew Davies
Author: Simon Davies
Author: Andrew Day
Author: Caroline Dixon
Author: Gareth Evans
Author: Saul N. Faust ORCID iD
Author: Mae Felongco
Author: Victoria Ferguson
Author: Sarah Fielding
Author: James Fisher
Author: Paul Fleming ORCID iD
Author: Sophie Fletcher
Author: Christopher Gale
Author: Bernadette Gallagher
Author: Amy Gladwell
Author: Ali Gondal
Author: Christopher Green
Author: Daniel Griffiths
Author: Kathryn Hall
Author: Claire Harris
Author: Laura Harris
Author: Ali Hassan
Author: Claire Hewitt
Author: Alexander Hicks
Author: David Hodgson
Author: Luke Hodgson
Author: Clare Hooper
Author: Sarah Horton
Author: Sarah Howard
Author: Ying Hu
Author: Robert Hull
Author: Jane Hunt
Author: Sajid Hussain
Author: Robert Irving
Author: Melanie Jackson
Author: Nicola Jackson
Author: Mark James
Author: Elinor Jenkins
Author: Stephen Jenkins
Author: Kathryn Johnson
Author: Mark Johnson ORCID iD
Author: Victoria Johnston
Author: Gareth Jones
Author: Laura Jones
Author: Sophie Jones
Author: Tiffany Joyce
Author: Michael Kelly
Author: Stephen Kelly
Author: Ali Khan
Author: Mohammad Khan
Author: Omar Khan
Author: Andy King
Author: Emma Lee
Author: Megan Lewis
Author: Sara Lock
Author: Stephen Lynch
Author: Karen Martin ORCID iD
Author: Sarah Martin
Author: David Miller
Author: Rachel Miller
Author: Heena Mistry
Author: Alan Mitchell
Author: Sally Moore
Author: Anna Morris
Author: Paul Morris
Author: Susan Morris
Author: Charlotte Moss
Author: Sarah Moss
Author: Rachel Owen
Author: Alistair Palmer
Author: Mark Parson
Author: Manish Patel
Author: Natalie Pattison
Author: Elizabeth Payne
Author: Karen Pearson
Author: Linda Porter
Author: Claire Price
Author: David Price
Author: Richard Pugh
Author: A. Rehman
Author: Matthew Rice
Author: Ian Roberts
Author: Calum Robertson
Author: Matthew Robinson
Author: Naomi Rogers
Author: Hitasha Rupani
Author: Peter Russell
Author: Matthew Ryan
Author: David Sammut
Author: A. Scott
Author: Syed Shah
Author: David Shaw
Author: Susanna Sherwin
Author: Thomas Simpson
Author: Amanda Smith
Author: Amy Smith
Author: Andrew Smith ORCID iD
Author: Catherine Smith
Author: Christopher Smith
Author: Hazel Smith ORCID iD
Author: Helen Smith
Author: Jeannette Smith
Author: Jessica Smith
Author: John Smith
Author: Lisa Smith
Author: Lucy Smith
Author: Matthew Smith
Author: Rachel Smith
Author: Rebecca Smith
Author: Richard Smith
Author: Stephanie Smith
Author: Susan Smith
Author: Natalie Staplin
Author: Monique Sterrenburg ORCID iD
Author: Nadia Sunni
Author: Alexander Taylor
Author: David Taylor
Author: Karen Taylor
Author: Matthew Taylor
Author: Rachel Taylor
Author: Amy Thomas
Author: James Thomas
Author: Megan Thomas
Author: Rebecca Thomas ORCID iD
Author: Rhys Thomas ORCID iD
Author: Sarah Thomas
Author: Catherine Thompson
Author: Fiona Thompson
Author: Laura Thompson
Author: Nicola Thomson
Author: Sarah Thorpe
Author: Mark Turner
Author: Samantha Turner
Author: Victoria Turner
Author: Claire Walker
Author: Louise Wallis
Author: Jocelyn Walters
Author: Deborah Ward
Author: Christopher White
Author: James White
Author: Christopher Wignall
Author: Claire Williams
Author: Felicity Williams
Author: Hannah Williams
Author: James Williams
Author: John Williams
Author: Karen Williams
Author: Sarah Williams
Author: Sophie Williams
Author: James Wilson
Author: Kit Y. Wong
Author: Stephen Wood
Author: Jane Woods
Author: David Yates
Author: Charlotte Yearwood Martin
Corporate Author: The RECOVERY Collaborative Group

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