Skip to main content
OpenTrials
Completed

NCT Number: NCT05195242

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Bleeding Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Hemorrhage Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thrombosis Embolism Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Södersjukhuset

Stockholm, Stockholm County, 11883, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

ATC code H02AB02

Other names: Dexavit

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • 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

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2022
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.