Hamburg Edoxaban for Anticoagulation in COVID-19 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 10
- 主要终点
- Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism
研究概览
简要总结
Hero-19 aims to evaluate if an intensive anticoagulation strategy using Edoxaban on top of standard of care (SOC) of COVID-19 therapy is superior to SOC (in-hospital moderate anticoagulation strategy = low-dose low-molecular weight heparin [LMWH], ambulatory no anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality endpoints in patients with COVID-19.
详细描述
Coagulopathy in the context of COVID-19 is a major threat to affected patients due to deep vein thromboses and pulmonary embolisms. Actual data show an unexpectedly high incidence of partially fatal complications without any prior clinical evidence in some cases. Therefore, this prospective, randomized, assessor-blinded, multicenter, placebo-controlled, interventional trial will investigate whether therapeutic anticoagulation on top of SOC compared to prophylactic anticoagulation as part of SOC- can improve objective patient-relative endpoints, relevant for prognosis in patients with COVID-19. 172 eligible patients will be randomized 1:1 to experimental or control group. Patients enrolled to experimental group will receive therapeutic anticoagulation using LMWH body weight-adapted during course of hospital stay and oral anticoagulation using Edoxaban according to SmPC (60mg once a day) after being discharged from hospital / outpatient course. Patients enrolled to control group will receive prophylactic anticoagulation using LMWH as part of SOC whilst inpatient course, and placebo after discharge / outpatient course. Patients will be informed of their allocation to the placebo group, as it has been shown that the effect of placebo is still detectable.
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
- Double (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
- 否
入选标准
- •Diagnosis of COVID-19 and hospitalization on ICU, or
- •Diagnosis of COVID-19 and hospitalization on normal ward, or
- •Diagnosis of COVID-19 (within 10 days) and troponin ≥ ULN and/or D-dimer ≥0.5 mg/L
排除标准
- •Age below 18
- •Life expectancy less than 3 months before COVID-19
- •Resuscitation > 30 minutes
- •Hypersensitivity to the active substance, to Edoxaban or any of its excipients
- •Significantly increased bleeding risk
- •Other indication for anticoagulation beyond COVID-19
- •GFR < 15 ml/min
- •Planned transfer of the patient to another clinic within the next 42 days
研究组 & 干预措施
Intensive anticoagulation strategy
In-hospital (ICU & normal ward): weight-adapted LMWH, high dose/ therapeutic dose (according to respective SmPC) After discharge and in ambulatory patients: Edoxaban according to SmPC
干预措施: Anticoagulation Agents (Edoxaban and/or high dose LMWH) (Drug)
Moderate anticoagulation strategy
In-hospital (ICU & normal ward): LMWH, prophylactic dose as part of SOC After discharge and in ambulatory patients: Administration of oral placebo according to the dosing rules for Edoxaban
干预措施: Low dose Low molecular weight heparin or Placebo (Drug)
结局指标
主要结局
Combined endpoint: all-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism
时间窗: 42 days
All-cause mortality and/ or venous thromboem-bolism and/ or arterial thromboembolism during follow-up (42 days). Thromboembolisms will be detected by duplex ultrasonography of arms and legs.
次要结局
- Rate and length of mechanical ventilation(42 days)
- Mortality related to venous thromboembolism(42 days)
- Mortality related to arterial thromboembolism(42 days)
- All-cause mortality(42 days)
- Rate of venous and/ or arterial thromboembolism(42 days)
- Rate and length of renal replacement therapy(42 days)
- Cardiac arrest/ CPR(42 days)
- Rehospitalisation(42 days)
- Length of initial stay at ICU after application of IMP(42 days)