NCT04442958已完成不适用
Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome
Bagcilar Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2020年5月15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
- 60
- 试验地点
- 2
- 主要终点
- Plasma fibrinogen level
研究概览
简要总结
The aim of the study is to evaluate the safety, improvement of clinical symptoms and laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients with ARDS.
详细描述
The aim of the study is to evaluate the safety, improvement of clinical symptoms with hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma treatment in severe Covid-19 patients followed up in critical care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Covid-19
排除标准
- •Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90
结局指标
主要结局
Plasma fibrinogen level
时间窗: 7. day
Coagulopathy
Plasma procalcitonin level
时间窗: 7. day
Infection markers
Plasma ferritin level
时间窗: 7. day
Acute phase reactant
D-Dimer level
时间窗: 7. day
Hypercoagulability
C-Reactive protein level
时间窗: 7. day
Infection markers
Lymphocyte count
时间窗: 7. day
Infection markers
次要结局
- Fractional Inspired Oxygen Level(7. day)
- Partial Oxygen Saturation level(7. day)
- Arterial Oxygen level(7. day)
研究者
研究点 (2)
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