The University of Southampton
University of Southampton Institutional Repository

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

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

Background: in this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation.

Methods: this randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg-800 mg (depending on weight) given intravenously. A second dose could be given 12-24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936).

Findings: between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76-0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12-1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77-0·92; p<0·0001).

INTERPRETATION: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids.

FUNDING: UK Research and Innovation (Medical Research Council) and National Institute of Health Research.

Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized/administration & dosage, COVID-19/complications, Female, Hospital Mortality, Hospitalization, Humans, Hypoxia/diagnosis, Male, Middle Aged, Oxygen Saturation, Respiration, Artificial/statistics & numerical data, SARS-CoV-2/isolation & purification, Severity of Illness Index, Treatment Outcome, Young Adult
0140-6736
1637-1645
Ahmed, Muhammad S.
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White, Christopher
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White, James
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Wilson, James
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Yong, H.
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The RECOVERY Collaborative Group
Ahmed, Muhammad S.
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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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Bailey, James
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The RECOVERY Collaborative Group (2021) Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial RECOVERY Collaborative Group. The Lancet, 397 (10285), 1637-1645. (doi:10.1016/S0140-6736(21)00676-0).

Record type: Article

Abstract

Background: in this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation.

Methods: this randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg-800 mg (depending on weight) given intravenously. A second dose could be given 12-24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936).

Findings: between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76-0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12-1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77-0·92; p<0·0001).

INTERPRETATION: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids.

FUNDING: UK Research and Innovation (Medical Research Council) and National Institute of Health Research.

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e-pub ahead of print date: 29 April 2021
Published date: 30 April 2021
Keywords: Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized/administration & dosage, COVID-19/complications, Female, Hospital Mortality, Hospitalization, Humans, Hypoxia/diagnosis, Male, Middle Aged, Oxygen Saturation, Respiration, Artificial/statistics & numerical data, SARS-CoV-2/isolation & purification, Severity of Illness Index, Treatment Outcome, Young Adult
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Identifiers

Local EPrints ID: 456451
URI: http://eprints.soton.ac.uk/id/eprint/456451
ISSN: 0140-6736
PURE UUID: e45575dd-e7b4-463e-b27f-79ce69648cdd
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 James Bailey: ORCID iD orcid.org/0000-0002-8784-4008
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 Simon Davies: ORCID iD orcid.org/0000-0003-1830-5403
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 Christine 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: 29 Apr 2022 16:45
Last modified: 24 May 2024 01:59

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Contributors

Author: Muhammad S. Ahmed ORCID iD
Author: Sam Allen
Author: Nicola Anderson
Author: John Atkinson ORCID iD
Author: Miriam Avery
Author: Dinesh Bagmane
Author: James Bailey ORCID iD
Author: Sarah Bailey
Author: Rebecca Baker
Author: Michelle Baker-Moffatt
Author: Amy Barker
Author: Richard Barlow
Author: Jazz Bartholomew
Author: Louise Bell
Author: Paul Bradley
Author: Karen Brooks
Author: Heather Brown ORCID iD
Author: Louise Brown
Author: Richard Brown ORCID iD
Author: Tom Brown
Author: Thomas Bull
Author: Matthew Burton
Author: Amy Campbell ORCID iD
Author: Jonathan Carter
Author: Michael Carter
Author: Katrina Cathie
Author: Emma Chambers
Author: Andrew Clark
Author: Charlotte Clark
Author: Louise Clark
Author: Matthew Clark
Author: Thomas Clark ORCID iD
Author: Robert Clarke
Author: Samantha Clarke
Author: Nicola Collins
Author: Eloise Cook
Author: David Cooper
Author: Lauren Cooper
Author: Katy Cotton
Author: Jonathan Curtis
Author: Helen Davies
Author: Karen Davies
Author: Matthew Davies
Author: Simon Davies ORCID iD
Author: Susan Dawson
Author: Andrew Day
Author: Caroline Dixon
Author: Gareth Evans
Author: Saul N. Faust ORCID iD
Author: Simon Fearby
Author: Mae Felongco
Author: Victoria Ferguson
Author: Karen Fielder
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: David Green
Author: Teresa Green
Author: Daniel Griffiths
Author: Kathryn Hall
Author: John Harris
Author: Laura Harris
Author: Thomas Harrison
Author: Ali Hassan
Author: Claire Hewitt
Author: David Hodgson
Author: Luke Hodgson
Author: Clare Hooper
Author: Sarah Horton
Author: Sarah Howard
Author: Ying Hu
Author: Robert Hull
Author: Sajid Hussain
Author: Robert Irving
Author: Melanie Jackson
Author: Nicola Jackson
Author: Mark James
Author: Rebecca James
Author: Elinor Jenkins
Author: Stephen Jenkins
Author: David Johnson
Author: Kathryn Johnson
Author: Mark Johnson ORCID iD
Author: Victoria Johnston
Author: Alistair Jones
Author: Emily Jones
Author: Gareth Jones
Author: Jessica Jones
Author: Laura Jones
Author: R. E. 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: Sara Lock
Author: Stephen Lynch
Author: Claire Macfadyen
Author: Karen Martin ORCID iD
Author: Heather McGuinness
Author: David Miller
Author: Rachel Miller
Author: Heena Mistry
Author: Alan Mitchell
Author: Christopher Moore
Author: Sally Moore
Author: Anna Morris
Author: Paul Morris
Author: Susan Morris
Author: Charlotte Moss
Author: Sarah Moss
Author: Ka Wing Ng
Author: Rachel Owen
Author: Alistair Palmer
Author: Sarah Parsons
Author: Kamal Patel
Author: Manish Patel
Author: David Payne
Author: Elizabeth Payne
Author: Karen Pearson
Author: Linda Porter
Author: Joanne B. Potts
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: Peter Russell
Author: Matthew Ryan
Author: David Sammut
Author: A. Scott
Author: Martha Scott
Author: Syed Shah
Author: David Shaw
Author: Susanna Sherwin
Author: Thomas Simpson
Author: Alex Smith
Author: Amanda Smith
Author: Amy Smith
Author: Andrew Smith ORCID iD
Author: Anna Smith
Author: Catherine Smith
Author: Christopher Smith
Author: Harriet Smith
Author: Hazel Smith ORCID iD
Author: Helen Smith
Author: Jessica Smith
Author: Kathryn Smith
Author: Lisa Smith
Author: Rachel Smith
Author: Rebecca Smith
Author: Richard Smith
Author: Stephanie Smith
Author: Susan Smith
Author: John Smith
Author: Natalie Staplin
Author: Monique Sterrenburg ORCID iD
Author: Melanie Stevens
Author: Colin Stewart
Author: Nadia Sunni
Author: John Sutton
Author: Adrian Tan
Author: Alexander Taylor
Author: David Taylor
Author: Karen Taylor
Author: Matthew Taylor
Author: Rachel Taylor
Author: James Thomas
Author: Rebecca Thomas ORCID iD
Author: Rhys Thomas ORCID iD
Author: Sarah Thomas
Author: Catherine Thompson
Author: Fiona Thompson
Author: Laura Thompson
Author: Michael Thompson
Author: Rebecca Thompson
Author: Nicola Thomson
Author: Sarah Thorpe
Author: Mark Turner
Author: Samantha Turner
Author: Victoria Turner
Author: Charlotte Underwood
Author: Louise Wallis
Author: Jocelyn Walters
Author: Deborah Ward
Author: Nicola Ward
Author: Andrew White
Author: Christopher White
Author: James White
Author: Christopher Wignall
Author: Claire Williams
Author: Hannah Williams
Author: James Williams
Author: John Williams
Author: Karen Williams
Author: Sarah Williams
Author: Sophie Williams
Author: James Wilson
Author: Alan Wong
Author: Kit Y. Wong
Author: Stephen Wood
Author: Jane Woods
Author: Rebecca Wright
Author: Stephanie Wright
Author: David Yates
Author: Charlotte Yearwood Martin
Author: H. Yong
Corporate Author: The RECOVERY Collaborative Group

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