Intermediate dose enoxaparin in hospitalized patients with moderate-severe COVID-19: a pilot phase II single-arm study, INHIXACOVID19 - INHIXACOVID19

ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA0 个研究点目标入组 100 人开始时间: 2020年6月24日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•-Age >=18 y
•-Microbiologically confirmed COVID-19 infection
•-Patients with moderate-severe disease according to study definitions (see below)
•-Informed consent
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•Thrombocytopenia (platelet count < 50.000 mm3)
•Coagulopathy: INR >1.5, aPTT ratio >1.4
•Impaired renal function (clearance to creatinine less than 15 ml/min)
•Known hypersensitivity to heparin
•History of heparin induced thrombocytopenia
•Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignat tumors at hig risk of haemorrahges, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations)
•Body weight <45 or > 150 kg
•Concomitant anticoagulant treatment for other indications ( eg atrial fibrillation, venous thromboembolism , prosthetic heart valves).
•Dual antiplatelet therapy
•Pregnant or breastfeeding women

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