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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05195242
Enrollment
445
Registered
2022-01-18
Start date
2020-08-27
Completion date
2021-06-30
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, COVID-19, Thrombosis Embolism

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.

Interventions

DRUGDexamethasone

ATC code H02AB02

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients discharged alive from the ICU without thromboembolic eventsDuring ICU-stayNumber 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

MeasureTime frameDescription
The cumulative proportion of thromboembolic eventsDuring ICU-stayThe 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 eventsDuring ICU-stayThe cumulative proportion of bleeding events defined as any type of bleeding
The cumulative proportion of major bleeding eventsDuring ICU-stayThe 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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026