NCT04535063已完成3 期
Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年4月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 28 days survival
研究概览
简要总结
To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia
详细描述
COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult patients ≥18, and non-pregnant women
- •Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with >50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction.
- •10 days from the onset of symptoms or ≤ 7 days on mechanical ventilation. -
排除标准
- •More than 10 days from symptoms onset or more than 7 days on mechanical ventilation
- •Pregnancy
- •Contraindication for plasma infusion because anaphylaxis history
- •Patients with high risk of circulatory overload
- •Limitation of therapeutic efforts
- •Refractory shock define by norepinephrine dose more than 1 ug/k/min
- •SOFA score more than 15 points at the moment of the protocol inclusion i Coagulopathy with requirements of plasma infusion
结局指标
主要结局
28 days survival
时间窗: 28 days
number of subjects surviving at 28 days from plasma infusion
次要结局
- change in clinical WHO ordinal scale from 1 to 10 points(14 days)
- efficacy of plasma infusion according to antibodies levels in the infuse bags(28 days)
- clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization(28 days)
研究者
Ricardo Valentini
Medical Doctor
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
研究点 (2)
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