Clinical trial NCT05195242: The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Thrombosis Embolism
Bleeding
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Scandinavian Critical Care Trials Group
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Centre for Research in Intensive Care (CRIC)
name: Aarhus University Hospital
name: Aalborg University Hospital
name: Rigshospitalet, Denmark
name: Linkoeping University
name: Stockholm South General Hospital
First posted: 2022-01-18
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

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

Primary outcomes:
measure: Number of patients discharged alive from the ICU without thromboembolic events
timeFrame: During ICU-stay
Secondary outcomes:
measure: The cumulative proportion of thromboembolic events
timeFrame: During ICU-stay
measure: The cumulative proportion of bleeding events
timeFrame: During ICU-stay
measure: The cumulative proportion of major bleeding events
timeFrame: During ICU-stay
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
state: Stockholms Län
Study officials:
affiliation: Karolinska Institutet Södersjukhuset
name: Rebecka Rubenson Wahlin, MD. PhD
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet Södersjukhuset
name: Maria Cronhjort, MD PhD
role: STUDY_CHAIR
References: