Status:
COMPLETED
The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Scandinavian Critical Care Trials Group
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
COVID-19
Thrombosis Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- All patients were recruited from the CS2-trial with following inclusion/exclusion 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
- 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
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT05195242
Start Date
August 27 2020
End Date
June 30 2021
Last Update
June 27 2022
Active Locations (1)
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1
Södersjukhuset
Stockholm, Stockholm County, Sweden, 11883