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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05195242
Other study ID # Thromboembolism COVIDSTEROID2
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 27, 2020
Est. completion date June 30, 2021

Study information

Verified date June 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 445
Est. completion date June 30, 2021
Est. primary completion date June 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Dexamethasone
ATC code H02AB02

Locations

Country Name City State
Sweden Södersjukhuset Stockholm Stockholms Län

Sponsors (9)

Lead Sponsor Collaborator
Karolinska Institutet 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

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients discharged alive from the ICU without thromboembolic events Number 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 During ICU-stay
Secondary The cumulative proportion of thromboembolic events The incidence of thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events During ICU-stay
Secondary The cumulative proportion of bleeding events The cumulative proportion of bleeding events defined as any type of bleeding During ICU-stay
Secondary The cumulative proportion of major bleeding events The 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 During ICU-stay
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