Early Thromboprophylaxis in COVID-19 (ETHIC Trial): an Open Label, Randomized Phase IIIb Trial of Community-based (LMWH) Versus Standard of Care (no Enoxaparin) in COVID-19 Positive Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 219
- 试验地点
- 3
- 主要终点
- Hospital Admission
研究概览
简要总结
Evidence has shown that COVID-19 infections can lead to an increased risk of blood clots. These blood clots can lead to individuals being admitted to hospital, or, unfortunately in severe cases, death. Enoxaparin is a blood-thinning drug which has been used by doctors and nurses in hospitals for many years to prevent the thickening of blood which may lead to a clot. It is easier for doctors to prevent new blood clots from forming than treating existing blood clots.
Currently, there are no treatments for COVID-19. There is an urgent need to find a safe and effective treatment to prevent worsening of the disease that may lead to hospital admission and/or death. The ETHIC (Early Thromboprophylaxis in COVID-19) study aims to find out if giving enoxaparin in an early stage of the COVID-19 disease can prevent individuals being admitted to hospital and/or death. The study will take place in approximately 8 to 10 countries, in approximately 30 to 50 centres.
Patients will be allowed to take part if they have had a confirmed COVID-19 infection, are ≥ 55 years of age and have at least two of the following additional risk factors; age ≥ 70 years, body mass index > 25 kg/m2, chronic obstructive pulmonary disease, diabetes, cardiovascular disease, or corticosteroid use.
Half the patients in the study will receive the blood-thinning drug enoxaparin for three weeks, and half will receive no treatment. Individuals will be randomly allocated to one of these groups. After 21 days, the number of patients in each group who were either admitted to hospital, or died, will be compared. The number of patients in each group who developed a blood clot (venous thromboembolism) will also be compared. Further comparisons will be made at both 50 and 90 days after the beginning of the study.
详细描述
This is an open label randomized controlled trial of symptomatic individuals with confirmed COVID-19 in a community setting.
Justification: There is currently no standard of care treatment for Covid-19.
Upon enrolment into the study, patients will be randomised to receive either enoxaparin (40 mg once per day if < 100 kg, 40 mg twice per day if ≥ 100 kg) or the current standard of care (no enoxaparin) for three weeks (21 days). Randomisation must occur within 5 days of the SARS-CoV-2 test. Data will be collected at baseline and 21 days, with further assessments at 50 and 90 days.
Participants randomised to enoxaparin will receive pre-loaded syringes as part of the study, and information regarding self-administration will be provided by the sponsor. Participants in the control arm of this study will receive no treatment (current standard of care).
Screening Phase:
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed consent
- •Confirmed COVID-19 (i.e. symptoms + positive test for SARS-CoV-2)
- •Male or female, age ≥ 55 years
- •At least two of the following additional risk factors:
- •Age ≥ 70 years Body mass index > 25 kg/m2 Chronic obstructive pulmonary disease (COPD)* Diabetes* Cardiovascular disease* Corticosteroid use
- •*Defined as any disease requiring medical intervention or treatment.
排除标准
- •Contraindications to unfractionated heparin or LMWH
- •Recent (<48 hours) or planned spinal or epidural anesthesia or puncture, PCI or thrombolytic therapy within the preceding 24 hours
- •Increased risk for bleeding complications
- •Pregnant women
- •Severe renal impairment (GFR < 30 mL/min)
- •Receiving any antiplatelet therapy (with the exception of low dose (≤100mg) aspirin) or anticoagulant therapy (e.g. VKA, DOAC)
- •Patients participating in an interventional study that is outside the purview of TRI sponsored studies.
研究组 & 干预措施
Enoxaparin
(40 mg o/d if < 100 kg, 40 mg b/d if ≥ 100 kg)
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Hospital Admission
时间窗: 90 days
Hospital admission including: Pneumonia Acute Respiratory distress syndrome Admission to intensive care unit (ICU) Mechanical ventilation (MV)/intubation requirement Continuous positive airway pressure (CPAP)/Non-invasive ventilation Extracorporeal membrane oxygenation (ECMO)
Death
时间窗: 90 days
All-cause Cardiovascular Non-Cardiovascular Specific causes Fatal bleed
次要结局
- Bleeding (as defined by ISTH criteria)(21 and 50 days)
- Diagnosis of VTE(21, 50 and 90 days)