Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in clotting factors level
研究概览
简要总结
Since the end of 2019, Egypt and the whole world have been suffering from the Coronavirus Disease 2019 (COVID-19) pandemic, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). According to the World Health Organization (WHO), since the emergence of this new pandemic, there have been more than 97 million confirmed cases of COVID-19 patients and two million death globally; around 160 thousand of these cases are in Egypt.
Recent clinical investigations found a high incidence of thrombotic complications in these patients, even with the standard anticoagulant thromboprophylaxis.Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Among the pathological sequel of COVID-19 infection, is the presence of a micro-thrombi in the pulmonary circulation which was shown in several autopsy studies. This thrombosis is believed to contribute to gas exchange impairment among patients with COVID-19 infection.
Some observational studies have shown anticoagulation benefits with reduced mortality, mainly in patients requiring mechanical ventilation. However, these findings remain uncertain and need to be validated in further studies.
This study is performed to evaluate whether therapeutic anticoagulation could improve COVID-19 patients' clinical outcomes compared to prophylactic anticoagulation in terms of improving gas exchange, reducing the need to maintain mechanical ventilation, shortening hospital admission period and mortality rate as well as recovering D-dimmer levels to its normal values.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years..
- •COVID-19 hospitalized patients with pneumonia proved by chest X-ray or CT scan.
- •Confirmed infection with COVID-19 virus using RT-PCR or strongly suspected to be infected with pending confirmation studies.
- •Prothrombin time/international normalized ratio (INR)<1.5; activated partial thromboplastin time (aPTT)/ratio<1.5, and platelet count greater than 100,000/mm3.
排除标准
- •Age greater than 85 years-old
- •Creatinine clearance (CrCl)<10ml/min.
- •Severe circulatory shock with a dose of norepinephrine higher than 1.0 μg/kg/min.
- •Pregnant women.
- •Recent major surgery or severe trauma in the last 3 weeks or recent hemorrhagic stroke in the last 3 months.
- •Active bleeding, blood dyscrasia such as hemophilia and Von Willebrand factor deficiency.
研究组 & 干预措施
Group 1
Enoxaparin therapeutic dose
干预措施: Enoxaparin (Drug)
Group 2
Enoxaparin prophylactic dose
干预措施: Enoxaparin (Drug)
Group 3
Rivaroxaban therapeutic dose
干预措施: Rivaroxaban (Drug)
Group 4
Rivaroxaban prophylactic dose
干预措施: Rivaroxaban (Drug)
Group 5
Apixaban therapeutic dose
干预措施: Apixaban (Drug)
Group 6
Apixaban prophylactic dose
干预措施: Apixaban (Drug)
结局指标
主要结局
Change in clotting factors level
时间窗: Two weeks
Difference in clotting factors levels between baseline during inclusion in the study and before discharge.
Change in gas exchange over time
时间窗: Two weeks
Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge.
Time to increase in oxygenation
时间窗: Two weeks
Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2
Duration of hospitalization
时间窗: Two weeks
Length of hospital stay
次要结局
- Monitoring of hemoglobin levels.(Two weeks)
- Monitoring of adverse events(Two weeks)
- In hospital mortality rate(Two weeks)
- Monitoring of platelets levels(Two weeks)
研究者
Neven Sarhan
Lecturer at Faculty of Pharmacy
Misr International University