A randomized, single-blind study with a parallel control group on the efficacy and safety of bemiparin at therapeutic dose vs. prophylactic dose in patients hospitalized for COVID-19

Fundación de Investigación HM Hospitales0 个研究点目标入组 120 人开始时间: 2020年7月22日最近更新: 2023年9月26日

试验速览

暂无简介。

•1. Informed consent.
•2. Age of 18 years or more.
•3. Patient with suspected COVID-19 and who meets hospitalization criteria.
•4. D-dimer> 500 ng / ml.
•5. Clinical characteristics highly compatible with SARS-CoV-2 infection and confirmation by RT-qPCR at baseline or in the second sample in case of a first negative test and clinical suspicion remains.
•6. Patient admitted to hospital
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1. ICU admission criteria.
•2. Pregnancy.
•3. Creatine clearance <30 ml / min (Cockroft-Gault).
•4. Severe liver or pancreatic function disorder.
•5. Acute bacterial endocarditis and slow endocarditis.
•6. Patient previously anticoagulated (although it is allowed to have received heparin at a previous low dose without time limit).
•7. Patient with high hemorrhagic risk due to previous medical-surgical history.
•8. Severe thrombocytopenia (<80,000 platelets / mm3) or known history of heparin-induced thrombocytopenia.
•9. Active bleeding or increased risk of bleeding from haemostasis disorders or from organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain malignancies).
•10. Damage or surgical interventions in the central nervous system, eyes and ears that have taken place in the last 2 months.
•11. Simultaneous participation in another clinical trial that could have a conflictive interaction with what it is intended to evaluate.
•12. Any situation that in the opinion of the researcher could interfere with the treatment or with the evolution of the patient.

发起方

Fundación de Investigación HM Hospitales