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

Phase 3

Completed

• Conditions: COVID-19; Thrombosis Embolism; Bleeding
• Interventions: Drug: Dexamethasone

• Registration Number: NCT05195242
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-27
• Primary Completion: 2021-06-20
• Study Completion: 2021-06-30
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-24
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone 12 mg	Dexamethasone	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.
Dexamethasone 6 mg	Dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Number of patients discharged alive from the ICU without thromboembolic events	During ICU-stay	Number of patients discharged alive from the ICU without thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events

Secondary Outcome Measures

Name	Time	Method
The cumulative proportion of major bleeding events	During ICU-stay	The cumulative proportion of major bleeding event (defined as bleeding requiring transfusion of at least 2 units of Red Blood Cells (RBC) and/or intracranial bleeding and/or bleeding resulting in need for major therapeutic intervention
The cumulative proportion of thromboembolic events	During ICU-stay	The incidence of thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events
The cumulative proportion of bleeding events	During ICU-stay	The cumulative proportion of bleeding events defined as any type of bleeding

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Stockholms Län, Sweden