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Hvidovre Hospital - a part of Copenhagen University Hospital
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Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia: the COVID STEROID randomised, placebo-controlled trial

Research output: Contribution to journalJournal articlepeer-review

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  • Marie Warrer Munch
  • Tine Sylvest Meyhoff
  • Marie Helleberg
  • Maj-Brit Nørregaard Kjaer
  • Anders Granholm
  • Carl Johan Steensen Hjortsø
  • Thomas Steen Jensen
  • Morten Hylander Møller
  • Peter Buhl Hjortrup
  • Mik Wetterslev
  • Gitte Kingo Vesterlund
  • Lene Russell
  • Vibeke Lind Jørgensen
  • Klaus Tjelle Kristiansen
  • Thomas Benfield
  • Charlotte Suppli Ulrik
  • Anne Sofie Andreasen
  • Morten Heiberg Bestle
  • Lone Musaeus Poulsen
  • Thomas Hildebrandt
  • Lene Surland Knudsen
  • Anders Møller
  • Christoffer Grant Sølling
  • Anne Craveiro Brøchner
  • Bodil Steen Rasmussen
  • Henrik Nielsen
  • Steffen Christensen
  • Thomas Strøm
  • Maria Cronhjort
  • Rebecka Rubenson Wahlin
  • Stephan M Jakob
  • Luca Cioccari
  • Balasubramanian Venkatesh
  • Naomi Hammond
  • Vivekanand Jha
  • Sheila Nainan Myatra
  • Marie Qvist Jensen
  • Jens Wolfgang Leistner
  • Vibe Sommer Mikkelsen
  • Jens S Svenningsen
  • Signe Bjørn Laursen
  • Emma Victoria Hatley
  • Camilla Meno Kristensen
  • Ali Al-Alak
  • Esben Clapp
  • Trine Bak Jonassen
  • Caroline Løkke Bjerregaard
  • Niels Christian Haubjerg Østerby
  • Mette Mindedahl Jespersen
  • Dalia Abou-Kassem
  • Mathilde Languille Lassen
  • Reem Zaabalawi
  • Mohammed Mahmoud Daoud
  • Suhayb Abdi
  • Nick Meier
  • Kirstine la Cour
  • Cecilie Bauer Derby
  • Birka Ravnholt Damlund
  • Jens Laigaard
  • Lene Lund Andersen
  • Johan Mikkelsen
  • Jeppe Lundholm Stadarfeld Jensen
  • Anders Hørby Rasmussen
  • Emil Arnerlöv
  • Mathilde Lykke
  • Mikkel Zacharias Bystrup Holst-Hansen
  • Boris Wied Tøstesen
  • Janne Schwab
  • Emilie Kabel Madsen
  • Christian Gluud
  • Theis Lange
  • Anders Perner
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BACKGROUND: In the early phase of the pandemic, some guidelines recommended the use of corticosteroids for critically ill patients with COVID-19, whereas others recommended against the use despite lack of firm evidence of either benefit or harm. In the COVID STEROID trial, we aimed to assess the effects of low-dose hydrocortisone on patient-centred outcomes in adults with COVID-19 and severe hypoxia.

METHODS: In this multicentre, parallel-group, placebo-controlled, blinded, centrally randomised, stratified clinical trial, we randomly assigned adults with confirmed COVID-19 and severe hypoxia (use of mechanical ventilation or supplementary oxygen with a flow of at least 10 L/min) to either hydrocortisone (200 mg/d) vs a matching placebo for 7 days or until hospital discharge. The primary outcome was the number of days alive without life support at day 28 after randomisation.

RESULTS: The trial was terminated early when 30 out of 1000 participants had been enrolled because of external evidence indicating benefit from corticosteroids in severe COVID-19. At day 28, the median number of days alive without life support in the hydrocortisone vs placebo group were 7 vs 10 (adjusted mean difference: -1.1 days, 95% CI -9.5 to 7.3, P = .79); mortality was 6/16 vs 2/14; and the number of serious adverse reactions 1/16 vs 0/14.

CONCLUSIONS: In this trial of adults with COVID-19 and severe hypoxia, we were unable to provide precise estimates of the benefits and harms of hydrocortisone as compared with placebo as only 3% of the planned sample size were enrolled.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT04348305. European Union Drug Regulation Authorities Clinical Trials (EudraCT) Database: 2020-001395-15.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Volume65
Issue number10
Pages (from-to)1421-1430
Number of pages10
ISSN0001-5172
DOIs
Publication statusPublished - Nov 2021

    Research areas

  • corticosteroids, COVID-19, hydrocortisone, placebo-controlled trial, randomised clinical trial, SARS-CoV-2

ID: 66420211