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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

445 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 Thrombosis Embolism Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

ATC code H02AB02

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

ATC code H02AB02

Interventions

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Dexamethasone

ATC code H02AB02

Intervention Type DRUG

Other Intervention Names

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Dexavit

Eligibility Criteria

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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

\- randomised in the ICU

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:

* established thromboembolism at randomisation
* established major bleeding at randomisation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes