Overview

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

Status:
Active, not recruiting
Trial end date:
2022-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
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
Treatments:
Dexamethasone
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

- admitted to ICU

Exclusion Criteria:

- previously randomized to the CS-2 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

- established thromboembolism at randomization.

- informed consent not obtainable