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NCT05195242

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

Completed Phase 3 Last updated 27 June 2022
What this trial tests

Phase 3 trial testing Dexamethasone in COVID-19 in 445 participants. Completed in 30 June 2021.

Timeline
27 August 2020
Primary endpoint
20 June 2021
30 June 2021

Quick facts

Lead sponsorKarolinska Institutet
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment445
Start date27 August 2020
Primary completion20 June 2021
Estimated completion30 June 2021
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with COVID-19 or Thrombosis Embolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Dexamethasone

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other Karolinska Institutet trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05195242.

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