EUCTR2020-005624-10-DE进行中（未招募）1 期
ENOXAPARIN FOR PRIMARY THROMBOPROPHYLAXIS IN AMBULATORY PATIENTS WITH CORONAVIRUS: THE MULTICENTER RANDOMIZED CONTROLLED OVID TRIA
niversity Hospital Zurich0 个研究点目标入组 1,000 人开始时间: 2021年3月8日最近更新:
适应症
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
- 1,000
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
- •1)Signs patient informed consent after being fully informed about the study’s background.
- •2)Patients aged 50 years or older with a positive test (PCR swab test) for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment.
- •3)Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature >37.5° C.
- •4)Ability of the patient to travel to the study center by private transportation, performed either by accompanying person from same household or by the patient him/herself (criterion valid for Switzerland only, where inclusion is not necessarily performed on the same day of SARS-CoV2 testing).
- •5)Ability to comply with standard hygiene requirements at the time of in-hospital visit, including a face mask and hand disinfectant.
- •6)Ability to walk from car to study center or reach it by wheel chair transport with the help of an accompanying person from the same household also complying with standard hygiene requirements (criterion valid for Switzerland only, where inclusion is not necessarily performed on the same day of SARS-CoV2 testing).
- •7)Ability to self-administer prefilled enoxaparin injections after instructions received at the study center or availability of a person living with the patient to administer enoxaparin
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •1)Any acute or chronic condition posing an indication for anticoagulant treatment, e.g. atrial fibrillation, prior VTE, acute confirmed symptomatic VTE, acute coronary syndrome.
- •2)Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history, comorbidity or predisposing strong risk factors for thrombosis:
- •a.Any of the following events occurring in the prior 30 days: fracture of lower limb, hospitalization for heart failure, hip/knee replacement, major trauma, spinal cord injury, stroke,
- •b.previous VTE,
- •c.histologically confirmed malignancy, which was diagnosed or treated (surgery, chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or inoperable.
- •3)Any clinically relevant bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 30 days prior to randomization or sign of acute bleeding.
- •4)Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute intracranial hemorrhage.
- •5)Hemoglobin <8 g/dL and platelet count <50 x 109 cells/L confirmed by recent laboratory test (results <90 days acceptable for Italy and Switzerland; laboratory test performed at baseline visit required for Germany).
- •6)Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy.
- •7) Severe renal insufficiency (baseline creatinine clearance <30 mL/min calculated using the Cockcroft-Gault formula) confirmed by recent laboratory test (<90 days).
- •8) Contraindications to enoxaparin therapy, including prior heparin-induced thrombocytopenia and known hypersensitivity.
- •9) Current use of dual antiplatelet therapy.
- •10) Participation in other interventional studies over the past 30 days.
- •11) Non-compliance or inability to adhere to treatment or lack of a family environment or support system for home treatment.
- •12) Cognitive impairment and/or inability to understand to information provided in the study information.
- •13) Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
研究者
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