NCT04604327Unknown3 期
Ensayo clínico Aleatorizado, Abierto, Para Evaluar el Efecto de Dosis profilácticas o terapéuticas de Bemiparina en Pacientes Con COVID-19
Clinica Universidad de Navarra, Universidad de Navarra12 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2020年10月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 164
- 试验地点
- 12
- 主要终点
- Clinical deterioration
研究概览
简要总结
Patients requiring hospitalization due to COVID-19 pneumonia (non-severe) will be randomized to standard prophylactic doses or full therapeutic dose of bemiparin (a LMWH) for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (equal or more than 18 yo)
- •Hospitalization at conventional wards due to COVID-19 related mild or moderate pneumonia (CURB65<3 points; Sat. O2>90%)
- •3-4 points according to the WHO ordinal scale.
- •Confirmed COVID-19 (PCR or other validated test)
- •D-dimer >500 ng/mL
- •Sign of informed consent
- •The patient is able, according to investigator's opinion, to deal with all the requirements of the clinical trial.
排除标准
- 未提供
研究组 & 干预措施
Prophylactic bemiparin (3,500 IU/day)
Active Comparator
Bemiparin 3,500 IU daily for 10 days
干预措施: Bemiparin sodium (Drug)
Full therapeutic bemiparin (weight adjusted)
Experimental
Bemiparin at full therapeutic dose, adjusted to body weight, for 10 days
干预措施: Bemiparin sodium (Drug)
结局指标
主要结局
Clinical deterioration
时间窗: 10 days
Combined outcome that includes number of patients who suffer any of the following: Death, ICU admission, mechanical ventilatory support, progression to moderate or severe ARDS (according to Berlin criteria) or arterial or venous thrombosis.
次要结局
未报告次要终点
研究者
研究点 (12)
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