• Anders Granholm, Marie Warrer Munch, Sheila Nainan Myatra, VijayaraghavanBharath Kumar TirupakuzhiBKTDepartment of Critical Care, Apollo Hospitals, Chennai, India.Chennai Critical Care Consultants, Chennai, India.The George Institute for Global Health, New Delhi, India., Maria Cronhjort, WahlinRebecka RubensonRRDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden., Stephan M Jakob, Luca Cioccari, Maj-Brit Nørregaard Kjær, Gitte Kingo Vesterlund, Tine Sylvest Meyhoff, Marie Helleberg, MøllerMorten HylanderMHDepartment of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark., Thomas Benfield, Balasubramanian Venkatesh, Naomi E Hammond, Sharon Micallef, Abhinav Bassi, Oommen John, Vivekanand Jha, Klaus Tjelle Kristiansen, Charlotte Suppli Ulrik, JørgensenVibeke LindVLDepartment of Thoracic Anaesthesiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., 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, and Anders Perner.
• Department of Intensive Care, Rigshospitalet-Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark. andersgran@gmail.com.
• Intensive Care Med. 2022 Jan 1; 48 (1): 455545-55.

PurposeWe 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.MethodsWe 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.ResultsThe 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.ConclusionWe 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.© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

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