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

Karolinska Institute

Status and phase: Completed; Phase 3

Conditions: COVID-19; Thrombosis Embolism; Bleeding

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT05195242

Thromboembolism COVIDSTEROID2

Details and patient eligibility

About

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.

Enrollment: 445 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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445 participants in 2 patient groups

Dexamethasone 12 mg

Experimental group

Description:

Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.

Treatment:

Drug: Dexamethasone

Dexamethasone 6 mg

Active Comparator group

Description:

Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.

Treatment:

Drug: Dexamethasone