NCT04432103终止3 期
Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- INCIDENCE OF CRITICAL PNEUMONIA
研究概览
简要总结
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.
详细描述
We will perform an open label two arms, non randomized trial giving Convalescent Plasma donated from recovered COVID-19 patients with positive serology to severe and clinical pneumonia COVID-19 patients admitted to the ABC Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age: >18 and <60 years
- •Body weight : >60 kg
- •Confirmed previous SARS CoV-2 infection
- •negative SARS CoV-2 test result
- •21 day without symptoms from the negative SARS CoV2 negative test
- •Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- •Positive COVID-19 IgG antibodies
- •Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- •Individuals who meet all regular voluntary donor eligibility requirements by the Mexican legislation.
- •Patients/recipients:
- •Age: >18 years
- •Admitted to the ABC Medical Center facility for the treatment of COVID-19
- •Patients with severe or critical COVID-19
- •Informed consent provided by the patient or healthcare proxy
排除标准
- •Patients/recipients:
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
- •Any other not controlled infection
- •Disseminated Intravascular Coagulopathy
- •Patient under dialysis
- •Patient with recent Hemorrhagic Stroke
- •Severe Ischemic Heart Disease
结局指标
主要结局
INCIDENCE OF CRITICAL PNEUMONIA
时间窗: 14 days after convalescent plasma administration
progression to critical stage
MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
时间窗: 28 days after convalescent plasma administration
mortality
次要结局
- INCIDENCE OF MECHANICAL VENTILATION(14 days after convalescent plasma treatment)
- DAYS OF MECHANICAL VENTILATION(28 days after convalescent plasma treatment)
研究者
研究点 (2)
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