EUCTR2020-003125-39-DE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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 consent form
- •Confirmed COVID-19 (i.e. symptoms + positive PCR test for SARS-CoV-2)
- •Male or female, age = 30 years
- •Negative pregnancy test for female patients of reproductive potential
- •At least one of the following additional risk factors:
- •o Age = 70 years
- •o Body mass index > 25 kg/m2
- •o Chronic obstructive pulmonary disease (COPD)*(chronic obstructive lung disease, chronic bronchitis, chronic obstructive asthma, interstitial lung disease)
- •o Diabetes*
- •o Cardiovascular disease*(coronary artery disease, PAD, heart valve disease, treated arrhythmia, heart failure, hypertension, congenital heart disease, prior stroke or TIA, carotid artery disease)
- •oPrevious venous thromboembolism (deep vein thrombosis or pulmonary embolism)
- •oLiver disease* (alcoholic cirrhosis, non-alcoholic cirrhosis, chronic non-alcoholic liver disease, chronic hepatitis C, chronic hepatitis B, cryptogenic cirrhosis).
- •oImmunocompromised state (due to blood or bone marrow transplant, immunodeficiencies, HIV infection, systemic corticosteroid use or other medication that weakens the immune system [e.g. active cancer treatment])
- •oAnaemia of chronic disease or sickle cell disease
- •*Defined as any disease requiring medical intervention or treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Contraindications to unfractionated heparin or LMWH (History of immune mediated heparin-induced thrombocytopenia, active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; hypersensitivity, etc).
- •Received any COVID-19 vaccination
- •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 clopidogrel (=75mg) monotherapy 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 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
进行中（未招募）
1 期
Early treatment of patients with symptoms and confirmed COVID-19 with medication to prevent the disease becoming worseow Molecular Weight Heparin (LMWH) thromboprophylaxis in patients with COVID-19EUCTR2020-003125-39-GBCYTE Global1,370
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