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

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.

Conditions

• COVID-19
• Thrombosis Embolism
• Bleeding

Interventions

DRUG

Dexamethasone

ATC code H02AB02

Sponsors & Collaborators

• Scandinavian Critical Care Trials Group

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Centre for Research in Intensive Care (CRIC)

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• Stockholm South General Hospital

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Rebecka Rubenson Wahlin, MD. PhD · Karolinska Institutet Södersjukhuset

• Maria Cronhjort, MD PhD · Karolinska Institutet Södersjukhuset

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-27

Primary Completion

2021-06-20

Completion

2021-06-30

Countries

• Sweden

Study Locations