EUCTR2020-003125-39-GB进行中（未招募）1 期
Early thromboprophylaxis in COVID-19 (ETHIC trial): an open label, randomized phase IIIb trial of community-based prophylactic low-molecular-weight heparin (LMWH) versus standard of care (no enoxaparin) in COVID-19 positive patients - ETHIC trial: Early LMWH in symptomatic COVID-19 positive patients
CYTE Global0 个研究点目标入组 1,370 人开始时间: 2020年10月19日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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:
- •o Age = 70 years
- •o Body mass index > 25 kg/m2
- •o Chronic obstructive pulmonary disease (COPD)*
- •o Diabetes*
- •o Cardiovascular disease*
- •o Corticosteroid use
- •*Defined as any disease requiring medical intervention or treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
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.
研究者
相似试验
进行中（未招募）
1 期
To study if giving a small dose of a blood-thinning drug (enoxaparin) at an early stage of the COVID-19 infection can prevent worsening of the illness and avoid the need for hospital admissioConfirmed diagnosis of SARS-CoV-2 with symptomatic infectionEUCTR2020-003125-39-DEThrombosis Research Institute1,370
进行中（未招募）
1 期
To study if giving a small dose of a blood-thinning drug (enoxaparin) at an early stage of the COVID-19 infection can prevent worsening of the illness and avoid the need for hospital admissioConfirmed diagnosis of SARS-CoV-2 with symptomatic COVID-19 infectionEUCTR2020-003125-39-BEThrombosis Research Institute1,370
招募中
3 期
ETHIC trial: Early LMWH in symptomatic COVID-19 positive patientsCTRI/2021/01/030373Thrombosis Research Institute
终止
3 期
Early Prophylactic Low-molecular-weight Heparin (LMWH) in Symptomatic COVID-19 Positive PatientsCOVID-19NCT04492254Thrombosis Research Institute219
已完成
不适用
Thrombosis Prevention TrialISRCTN63594484Sponsor not defined - Record provided by the Medical Research Council (UK)5,499