Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Mortality at ICU at 90 days
研究概览
简要总结
This study aims to collect convalescent plasma and use it as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.
详细描述
This study aims to use convalescent plasma as experimental treatment in critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive care unit. Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19 patients on mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years or more.
- •Patient with Covid-19 confirmed with nuclear acid testing
- •Critically ill patients with Covid-19 on mechanical ventilation. Potencially critically ill patients (with acute respiratory distress syndrome, septic shock and/or multiple organ failure) with Covid-
- •Diagnosed with acute respiratory distress syndrome.
- •Informed consent.
排除标准
- •No consent.
- •Symptoms for a period longer than 20 days.
- •Not detectable by acid nuclear testing within 48 hours prior to elegibility.
- •Descompensated congestive heart failure, in which receiving 500ml of intrasvascular volume signifies a life risk.
- •History of severe adverse events or anaphylaxis to plasma components
结局指标
主要结局
Mortality at ICU at 90 days
时间窗: Mortality at 90 days
Mortality at 90 days of ICU admission
Mortality at ICU at 30 days
时间窗: Mortality at 30 days
Mortality at 30 days of Intensive Care Unit (ICU) admission
次要结局
- SOFA score of study days 1, 3, 5, 7, 14 and 28(Study days 1, 3, 5, 7, 14 and 28)
- Need for supportive therapy after enrollment(Duration of supportive therapy through study completion, an average of 3 months)
- Lenght of stay in ICU(Duration of stay in ICU through study completion, an average of 3 months)
- Lenght of mechanical ventilation(Duration of mechanical ventilation through study completion, an average of 3 months)
- Lenght of hospitalization(Duration of hospitalization through study completion, an average of 3 months)
研究者
Carlos Alberto Gonzalez
Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz
Hospital de Infecciosas Francisco Javier Muniz