Dexamethasone in Hospitalized Patients with Covid-19.

Administration, Oral Aged Aged, 80 and over Anti-Infective Agents / therapeutic use COVID-19 / mortality Dexamethasone / administration & dosage Drug Therapy, Combination Female Glucocorticoids / administration & dosage Hospitalization Humans Injections, Intravenous Kaplan-Meier Estimate Length of Stay Male Odds Ratio Oxygen Inhalation Therapy Respiration, Artificial United Kingdom COVID-19 Drug Treatment

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
25 Feb 2021

Historique:

pubmed: 18 7 2020

medline: 2 3 2021

entrez: 18 7 2020

Statut: ppublish

Résumé

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. 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 final results of this assessment. 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, 0.92 to 1.55). 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.).

Sections du résumé

BACKGROUND BACKGROUND

METHODS 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 final results of this assessment.

RESULTS 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, 0.92 to 1.55).

CONCLUSIONS 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.).

Identifiants

DOI: 10.1056/NEJMoa2021436 PMID: 32678530 PMC: PMC7383595

pubmed: 32678530

doi: 10.1056/NEJMoa2021436

pmc: PMC7383595

doi:

Substances chimiques

Anti-Infective Agents 0

Glucocorticoids 0

Dexamethasone 7S5I7G3JQL

Banques de données

ClinicalTrials.gov

['NCT04381936']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

693-704

Subventions

Organisme : Medical Research Council

ID : G0701652

Pays : United Kingdom

Organisme : UK Research and Innovation

ID : MC_PC_19056

Organisme : Medical Research Council

ID : MC_UU_00017/3

Pays : United Kingdom

Organisme : Medical Research Council

ID : MC_PC_18033

Pays : United Kingdom

Organisme : Medical Research Council

ID : MR/K025643/1

Pays : United Kingdom

Organisme : National Institute for Health Research

ID : MC_PC_19056

Organisme : Department of Health

ID : RP-2014-05-019

Pays : United Kingdom

Organisme : Wellcome Trust

Pays : United Kingdom

Organisme : Medical Research Council

ID : MC_UU_00002/14

Pays : United Kingdom

Organisme : Medical Research Council

ID : MR/S001751/1

Pays : United Kingdom

Organisme : Medical Research Council

ID : MC_PC_20062

Pays : United Kingdom

Organisme : Medical Research Council

ID : MC_PC_20029

Pays : United Kingdom

Organisme : Medical Research Council

ID : MC_U137686860

Pays : United Kingdom

Organisme : Medical Research Council

ID : MC_UU_12026/4

Pays : United Kingdom

Investigateurs

P Horby (P)

M J Landray (MJ)

R Haynes (R)

E Juszczak (E)

J K Baillie (JK)

L Chappell (L)

S N Faust (SN)

T Jaki (T)

K Jeffery (K)

W S Lim (WS)

M Mafham (M)

A Montgomery (A)

K Rowan (K)

P Sandercock (P)

J Darbyshire (J)

D DeMets (D)

R Fowler (R)

D Lalloo (D)

I Roberts (I)

J Wittes (J)

J Emberson (J)

N Staplin (N)

L Fletcher (L)

J Barton (J)

A Basoglu (A)

R Brown (R)

W Brudlo (W)

S Howard (S)

G McChlery (G)

K Taylor (K)

G Cui (G)

B Goodenough (B)

A King (A)

M Lay (M)

D Murray (D)

W Stevens (W)

K Wallendszus (K)

R Welsh (R)

C Crichton (C)

J Davies (J)

R Goldacre (R)

C Harper (C)

F Knight (F)

J Latham-Mollart (J)

M Nunn (M)

H Salih (H)

J Welch (J)

M Campbell (M)

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Dexamethasone in Hospitalized Patients with Covid-19.

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