The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19

The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19 - a Post-hoc Analysis of the Blinded, Randomized COVID STEROID 2 Trial

Thromboembolisms (TEs) in patients with critical COVID-19 has been reported to be three times higher than for other critically ill patients. Immunothrombosis has been proposed as a plausible mechanism for COVID-19 coagulopathy. Corticosteroids improve survival in patients with critical COVID-19, and likely even more so with a higher dose. However, the evidence regarding the impact on the incidence of thromboembolic and bleeding events are currently uncharted. The aim of this study is to investigate if there is a difference in the incidence of thromboembolic events during ICU stay in patients with critical COVID-19 when treated with 12 mg dexamethasone compared to 6 mg dexamethasone.

All patients were recruited from the CS2-trial with following inclusion/exclusion criteria:

Inclusion Criteria:

• confirmed SARS-CoV-2 AND
• requiring at least 10l/min of O2 supplementation, non-invasive mechanical ventilation for hypoxia or invasive mechanical AND

Exclusion Criteria:

• if previously randomised to the CS2 trial
• if they had received corticosteroids for COVID-19 during ≥5 consecutive days or use corticosteroids in doses >6 mg dexamethasone for an indication other than COVID-19.
• active tuberculosis
• hypersensitivity to dexa-/betamethasone
• active fungal infection
• fertile woman ≤60 years of age with a positive U-HCG/P-HCG test
• informed consent not obtainable

For the inclusion in this post-hoc analyses there is additional criteria:

Inclusion Criteria:

- randomised in the ICU

Exclusion Criteria:

• established thromboembolism at randomisation
• established major bleeding at randomisation