drugset / Trial / NCT05195242
The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19
Phase 3
Completed
445 enrolled
Karolinska Institutet
Aalborg University Hospital · collabAarhus University Hospital · collabCentre for Research in Intensive Care (CRIC) · collabCopenhagen Trial Unit, Center for Clinical Intervention Research · collabLinkoeping University · collabRigshospitalet, Denmark · collabScandinavian Critical Care Trials Group · collabStockholm South General Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2020-08-27
- Primary completion
- 2021-06-20
- Completion
- 2021-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 6 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 12 mg | Intravenous |