Dexamethasone in Hospitalized Patients with Covid-19

The RECOVERY Collaborative Group

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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 final results of this assessment.

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: 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.).

Original languageEnglish
Pages (from-to)693-704
Number of pages12
JournalNew England Journal of Medicine
Volume384
Issue number8
Early online date17 Jul 2020
DOIs
Publication statusPublished - 25 Feb 2021

Bibliographical note

Funding Information:
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.)

Funding Information:
Dr. Lim reports receiving grant support from Pfizer; Dr. Emberson, receiving grant support from Boehringer Ingelheim; Dr. Mafham, receiving grant support and provision of materials from the Medicines Company/Novartis; Dr. Staplin, receiving grant support from Boehringer Ingelheim; Dr. Faust, receiving grant support, lecture fees, and advisory board fees, all paid to his institution, from Pfizer, advisory board fees, paid to his institution, from AstraZeneca, Seqirus, Sandoz, and MedImmune, grant support and advisory board fees, all paid to his institution, from Sanofi and Merck, and grant support, paid to his institution, from GSK and Johnson & Johnson; Dr. Haynes, receiving grant support from the Medicines Company and Boehringer Ingelheim; Dr. Landray, receiving grant support from Novartis, Boehringer Ingelheim, and Merck Sharp & Dohme. No other potential conflict of interest relevant to this article was reported.

Funding Information:
Supported by a grant (MC_PC_19056) to the University of Oxford from the Medical Research Council of United Kingdom Research and Innovation and the National Institute for Health Research (NIHR); and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit, the NIHR Health Protection Unit in Emerging and Zoonotic Infections, and NIHR Clinical Trials Unit Support Funding. Dr. Lim is supported by core funding provided by NIHR Nottingham Biomedical Research Centre, Dr. Felton by the NIHR Manchester Biomedical Research Centre, and Dr. Jaki by a grant (MC_UU_0002/14) from the UK Medical Research Council and by an NIHR Senior Research Fellowship (NIHR-SRF-2015-08-001). Tocilizumab was provided free of charge for this study by Roche. AbbVie contributed some supplies of lopinavir–ritonavir for use in the trial. Regeneron contributed supplies of REGN-COV2 for use in the clinical trial. Other medications, including dexamethasone, that were used in the trial were supplied by the National Health Service (NHS).

Publisher Copyright:
© 2020 Massachusetts Medical Society.

Structured keywords

  • Anaesthesia Pain and Critical Care
  • Covid19

Keywords

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Anti-Infective Agents/therapeutic use
  • COVID-19/drug therapy
  • 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

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