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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- Number of patients discharged alive from the ICU without thromboembolic events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •confirmed SARS-CoV-2 AND
- •requiring at least 10l/min of O2 supplementation, non-invasive mechanical ventilation for hypoxia or invasive mechanical AND
排除标准
- •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-
- •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
研究组 & 干预措施
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.
干预措施: Dexamethasone (Drug)
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.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of patients discharged alive from the ICU without thromboembolic events
时间窗: 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
次要结局
- The cumulative proportion of major bleeding events(During ICU-stay)
- The cumulative proportion of thromboembolic events(During ICU-stay)
- The cumulative proportion of bleeding events(During ICU-stay)
研究者
Sandra Jonmarker
MD, Consultant in Intensive Care and Anaesthesiology
Karolinska Institutet