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

Primary Purpose

COVID-19, Thrombosis Embolism, Bleeding

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexamethasone 12 mg

Dexamethasone 6 mg

Arm Description

Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.

Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
The cumulative proportion of bleeding events
The cumulative proportion of bleeding events defined as any type of bleeding
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

Full Information

First Posted
January 13, 2022
Last Updated
June 24, 2022
Sponsor
Karolinska Institutet
Collaborators
Scandinavian Critical Care Trials Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Centre for Research in Intensive Care (CRIC), Aarhus University Hospital, Aalborg University Hospital, Rigshospitalet, Denmark, Linkoeping University, Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05195242
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Scandinavian Critical Care Trials Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Centre for Research in Intensive Care (CRIC), Aarhus University Hospital, Aalborg University Hospital, Rigshospitalet, Denmark, Linkoeping University, Stockholm South General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Thrombosis Embolism, Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone 12 mg
Arm Type
Experimental
Arm Description
Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.
Arm Title
Dexamethasone 6 mg
Arm Type
Active Comparator
Arm Description
Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexavit
Intervention Description
ATC code H02AB02
Primary Outcome Measure Information:
Title
Number of patients discharged alive from the ICU without thromboembolic events
Description
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
Time Frame
During ICU-stay
Secondary Outcome Measure Information:
Title
The cumulative proportion of thromboembolic events
Description
The incidence of thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events
Time Frame
During ICU-stay
Title
The cumulative proportion of bleeding events
Description
The cumulative proportion of bleeding events defined as any type of bleeding
Time Frame
During ICU-stay
Title
The cumulative proportion of major bleeding events
Description
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
Time Frame
During ICU-stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecka Rubenson Wahlin, MD. PhD
Organizational Affiliation
Karolinska Institutet Södersjukhuset
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Cronhjort, MD PhD
Organizational Affiliation
Karolinska Institutet Södersjukhuset
Official's Role
Study Chair
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
State/Province
Stockholms Län
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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