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Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial

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  1. Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia

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  4. Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Anders Granholm
  • Marie Warrer Munch
  • Sheila Nainan Myatra
  • Bharath Kumar Tirupakuzhi Vijayaraghavan
  • Maria Cronhjort
  • Rebecka Rubenson Wahlin
  • Stephan M Jakob
  • Luca Cioccari
  • Maj-Brit Nørregaard Kjær
  • Gitte Kingo Vesterlund
  • Tine Sylvest Meyhoff
  • Marie Helleberg
  • Morten Hylander Møller
  • Thomas Benfield
  • Balasubramanian Venkatesh
  • Naomi E Hammond
  • Sharon Micallef
  • Abhinav Bassi
  • Oommen John
  • Vivekanand Jha
  • Klaus Tjelle Kristiansen
  • Charlotte Suppli Ulrik
  • Vibeke Lind Jørgensen
  • Margit Smitt
  • Morten H Bestle
  • Anne Sofie Andreasen
  • Lone Musaeus Poulsen
  • Bodil Steen Rasmussen
  • Anne Craveiro Brøchner
  • Thomas Strøm
  • Anders Møller
  • Mohd Saif Khan
  • Ajay Padmanaban
  • Jigeeshu Vasishtha Divatia
  • Sanjith Saseedharan
  • Kapil Borawake
  • Farhad Kapadia
  • Subhal Dixit
  • Rajesh Chawla
  • Urvi Shukla
  • Pravin Amin
  • Michelle S Chew
  • Christian Aage Wamberg
  • Christian Gluud
  • Theis Lange
  • Anders Perner
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PURPOSE: We compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation.

METHODS: We analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone.

RESULTS: The adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI -0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses.

CONCLUSION: We found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.

Original languageEnglish
JournalIntensive Care Medicine
Volume48
Issue number1
Pages (from-to)45-55
Number of pages11
ISSN0342-4642
DOIs
Publication statusPublished - Jan 2022

Bibliographical note

© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

    Research areas

  • Bayesian analysis, Corticosteroids, COVID-19, Critical illness, Hypoxaemia

ID: 68905796