Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia: The COVID STEROID randomised, placebo-controlled trial

Marie Warrer Munch*, Tine Sylvest Meyhoff, Marie Helleberg, Maj Brit Nørregaard Kjær, 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 HildebrandtLene 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

*Corresponding author for this work

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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
Issue number10
Pages (from-to)1421-1430
Publication statusPublished - Nov 2021

Bibliographical note

Publisher Copyright:
© 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd


  • corticosteroids
  • COVID-19
  • hydrocortisone
  • placebo-controlled trial
  • randomised clinical trial
  • SARS-CoV-2
  • Humans
  • Adult
  • Hypoxia
  • Treatment Outcome
  • Hydrocortisone


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