Effects of 12 mg vs. 6 mg dexamethasone on thromboembolism and bleeding in patients with critical COVID-19 - a post hoc analysis of the randomized, blinded COVID STEROID 2 trial

Sandra Jonmarker*, Felix Alarcón, Jacob Litorell, Anders Granholm, Eva Joelsson Alm, Michelle Chew, Lene Russell, Sarah Weihe, Emilie Kabel Madsen, Nick Meier, Jens Wolfgang Leistner, Johan Mårtensson, Jacob Hollenberg, Anders Perner, Maj-Brit Nørregaard Kjær, Marie Warrer Munch, Martin Dahlberg, Maria Cronhjort, Rebecka Rubenson Wahlin

*Corresponding author for this work

Abstract

BACKGROUND: Thromboembolism is more common in patients with critical COVID-19 than in other critically ill patients, and inflammation has been proposed as a possible mechanism. The aim of this study was to investigate if 12 mg vs. 6 mg dexamethasone daily reduced the composite outcome of death or thromboembolism in patients with critical COVID-19.

METHODS: Using additional data on thromboembolism and bleeding we did a post hoc analysis of Swedish and Danish intensive care unit patients enrolled in the blinded randomized COVID STEROID 2 trial comparing 12 mg vs. 6 mg dexamethasone daily for up to 10 days. The primary outcome was a composite outcome of death or thromboembolism during intensive care. Secondary outcomes were thromboembolism, major bleeding, and any bleeding during intensive care.

RESULTS: We included 357 patients. Whilst in intensive care, 53 patients (29%) in the 12 mg group and 53 patients (30%) in the 6 mg group met the primary outcome with an unadjusted absolute risk difference of - 0.5% (95% CI - 10 to 9.5%, p = 1.00) and an adjusted OR of 0.93 (CI 95% 0.58 to 1.49, p = 0.77). We found no firm evidence of differences in any of the secondary outcomes.

CONCLUSIONS: Among patients with critical COVID-19, 12 mg vs. 6 mg dexamethasone daily did not result in a statistically significant difference in the composite outcome of death or thromboembolism. However, uncertainty remains due to the limited number of patients.

Original languageEnglish
Article number12
JournalAnnals of Intensive Care
Volume13
Issue number1
ISSN2110-5820
DOIs
Publication statusPublished - 2 Mar 2023

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