NCT04358003已完成不适用
Plasma Adsorption in Patients With Confirmed COVID-19 Infection
Marker Therapeutics AG14 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2020年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 14
- 主要终点
- All-cause mortality
研究概览
简要总结
To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU.
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
- •Age ≥ 18 years old
- •Admitted to ICU
- •Diagnosis of SARS-CoV-2 with any one of the following conditions:
- •Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
- •Severe disease, defined as:
- •respiratory frequency ≥ 30/min
- •blood oxygen saturation ≤ 93%
- •partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
- •lung infiltrates > 50% within 24 to 48 hours; or
- •Life-threatening disease, defined as:
- •respiratory failure,
- •septic shock, and/or
- •multiple organ dysfunction or failure.
- •Patient fact sheet is provided to the subject.
- •Subject or legal representative is able and willing to give informed consent. If authorized by the IRB, emergent plasma adsorption with the D2000 cartridge may be initiated prior to consent.
排除标准
- •Treatment limitation or a do not attempt to resuscitate in place
- •Pregnancy
- •Significant or uncontrolled bleeding
- •In the opinion of the investigator, any other condition that precludes plasma adsorption with the D2000
结局指标
主要结局
All-cause mortality
时间窗: Day 28
次要结局
- Change in Sequential Organ Failure Assessment [SOFA] scores(Day 28)
研究者
研究点 (14)
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