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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05195242
Recruitment Status : Active, not recruiting
First Posted : January 18, 2022
Last Update Posted : February 1, 2022
Sponsor:
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
Information provided by (Responsible Party):
Sandra Jonmarker, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
COVID-19 Thrombosis Embolism Bleeding Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 27, 2020
Actual Primary Completion Date : June 17, 2021
Estimated Study Completion Date : February 28, 2022


Arm Intervention/treatment
Experimental: Dexamethasone 12 mg
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.
Drug: Dexamethasone
ATC code H02AB02
Other Name: Dexavit

Active Comparator: Dexamethasone 6 mg
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.
Drug: Dexamethasone
ATC code H02AB02
Other Name: Dexavit




Primary Outcome Measures :
  1. Number of patients discharged alive from the ICU without thromboembolic events [ Time Frame: During ICU-stay ]
    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 :
  1. The cumulative proportion of thromboembolic events [ Time Frame: During ICU-stay ]
    The incidence of thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events

  2. The cumulative proportion of bleeding events [ Time Frame: During ICU-stay ]
    The cumulative proportion of bleeding events defined as any type of bleeding

  3. The cumulative proportion of major bleeding events [ Time Frame: During ICU-stay ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195242


Locations
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Sweden
Södersjukhuset
Stockholm, Stockholms Län, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
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
Investigators
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Study Director: Rebecka Rubenson Wahlin, MD. PhD Karolinska Institutet Södersjukhuset
Study Chair: Maria Cronhjort, MD PhD Karolinska Institutet Södersjukhuset
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Responsible Party: Sandra Jonmarker, MD, Consultant in Intensive Care and Anaesthesiology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT05195242    
Other Study ID Numbers: Thromboembolism COVIDSTEROID2
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022

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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
Additional relevant MeSH terms:
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COVID-19
Thrombosis
Embolism
Thromboembolism
Embolism and Thrombosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents