Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.
详细描述
This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Not masked
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
- •positive reverse transcriptase PCR test for COVID 19
- •COVID-19 pneumonia
- •All patients included were adults (>18 years)
- •Acute respiratory failure
排除标准
- •pregnant women
- •patients with suspected or confirmed pulmonary embolism
- •patients with terminal disease
结局指标
主要结局
Survival
时间窗: 30 day period
Number of Participants who Survived
次要结局
- P/F Ratio(7 day period)
- Lactate Dehydrogenase (LDH)(7 day period)
- Ferritin(7 day period)
- C Reactive Protein (CRP)(7 day period)
研究者
Novacescu Alexandru
Director of trial - Supervisor
University of Medicine and Pharmacy "Victor Babes" Timisoara