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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195242
• Other study ID #: Thromboembolism COVIDSTEROID2
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: June 30, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• COVID-19
• Embolism
• Embolism and Thrombosis
• Thromboembolism
• Thrombosis
• Thrombosis Embolism

Intervention

Drug:
• Dexamethasone
ATC code H02AB02

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm	Stockholms Län

Sponsors (9)

Lead Sponsor	Collaborator
Karolinska Institutet	Aalborg University Hospital, Aarhus University Hospital, Centre for Research in Intensive Care (CRIC), Copenhagen Trial Unit, Center for Clinical Intervention Research, Linkoeping University, Rigshospitalet, Denmark, Scandinavian Critical Care Trials Group, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients discharged alive from the ICU without thromboembolic events	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	During ICU-stay
Secondary	The cumulative proportion of thromboembolic events	The incidence of thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events	During ICU-stay
Secondary	The cumulative proportion of bleeding events	The cumulative proportion of bleeding events defined as any type of bleeding	During ICU-stay
Secondary	The cumulative proportion of major bleeding events	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	During ICU-stay