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Dexamethasone in Hospitalized Patients with Covid-19 - Preliminary Report

Dexamethasone in Hospitalized Patients with Covid-19 - Preliminary Report
Dexamethasone in Hospitalized Patients with Covid-19 - Preliminary Report

BACKGROUND: Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.

METHODS: In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison.

RESULTS: A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).

CONCLUSIONS: In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.).

0028-4793
693-704
Horby, Peter
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Lim, Wei Shen
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Emberson, Jonathan
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Mafham, Marion
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Bell, Jennifer L.
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Linsell, Louise
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Staplin, Natalie Dawn
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Brightling, Christopher E.
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Ustianowski, Andrew
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Elmahi, Einas
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Prudon, Benjamin
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Green, Christopher
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Felton, Timothy
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Chadwick, David
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Rege, Kanchan
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Fegan, Christopher
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Chappell, Lucy C.
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Faust, Saul N.
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Jaki, Thomas
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Jeffery, Katie
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Montgomery, Alan
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Rowan, Kathryn
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Juszczak, Edmund
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Baillie, J. Kenneth
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Haynes, Richard
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Landray, Martin J.
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The RECOVERY Collaborative Group
Horby, Peter
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Lim, Wei Shen
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Emberson, Jonathan
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Mafham, Marion
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Bell, Jennifer L.
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Linsell, Louise
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Staplin, Natalie Dawn
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Brightling, Christopher E.
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Ustianowski, Andrew
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Elmahi, Einas
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Prudon, Benjamin
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Green, Christopher
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Felton, Timothy
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Chadwick, David
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Rege, Kanchan
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Fegan, Christopher
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Chappell, Lucy C.
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Faust, Saul N.
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Jaki, Thomas
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Jeffery, Katie
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Montgomery, Alan
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Rowan, Kathryn
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Juszczak, Edmund
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Baillie, J. Kenneth
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Haynes, Richard
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Landray, Martin J.
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The RECOVERY Collaborative Group (2020) Dexamethasone in Hospitalized Patients with Covid-19 - Preliminary Report. New England Journal of Medicine, 384, 693-704, [NEJMoa2021436]. (doi:10.1056/NEJMoa2021436).

Record type: Article

Abstract

BACKGROUND: Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.

METHODS: In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison.

RESULTS: A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55).

CONCLUSIONS: In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.).

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Accepted/In Press date: 14 July 2020
e-pub ahead of print date: 17 July 2020
Published date: 17 July 2020

Identifiers

Local EPrints ID: 442903
URI: http://eprints.soton.ac.uk/id/eprint/442903
ISSN: 0028-4793
PURE UUID: 6496e238-7003-4d9e-bd4d-51cde39ed993
ORCID for Saul N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 30 Jul 2020 16:34
Last modified: 12 May 2021 04:01

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Contributors

Author: Peter Horby
Author: Wei Shen Lim
Author: Jonathan Emberson
Author: Marion Mafham
Author: Jennifer L. Bell
Author: Louise Linsell
Author: Natalie Dawn Staplin
Author: Christopher E. Brightling
Author: Andrew Ustianowski
Author: Einas Elmahi
Author: Benjamin Prudon
Author: Christopher Green
Author: Timothy Felton
Author: David Chadwick
Author: Kanchan Rege
Author: Christopher Fegan
Author: Lucy C. Chappell
Author: Saul N. Faust ORCID iD
Author: Thomas Jaki
Author: Katie Jeffery
Author: Alan Montgomery
Author: Kathryn Rowan
Author: Edmund Juszczak
Author: J. Kenneth Baillie
Author: Richard Haynes
Author: Martin J. Landray
Corporate Author: The RECOVERY Collaborative Group

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