Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis / Plasmaféresis terapéutica en Pacientes Adultos críticamente Enfermos Con diagnóstico Confirmado de COVID-19
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- In-hospital mortality
研究概览
简要总结
Introduction: The SARS-CoV-2 outbreak has left more than two million infected worldwide in the first four months of COVID-19 epidemic. To date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. Strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease.
Aim: To establish clinical response of critically ill patients with COVID-19 who received convalescent plasma from subjects recovered from SARS-CoV-2 during their stay in Intensive Care Unit at Fundación Cardiovascular de Colombia (Hospital Internacional de Colombia).
Methodology: Quasi-experimental study (no randomization will be performed). Adult patients who meet selection criteria will receive 500 ml of ABO compatible convalescent plasma, obtained by apheresis from patients recovered from SARS-CoV-2 infection. The main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of ABO compatible plasma units. A survival analysis will be performed using Kaplan-Meier method and association strength will be reported using HR and 95% CI crude and adjusted for confounding variables.
Expected results: It is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.
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 range: Over 18 years old
- •Patients with confirmed infection by COVID-19 (positive real-time PCR) in ICU with:
- •Respiratory failure receiving ventilatory support and high parameters
- •Severe pneumonia with rapid progression
- •Ability to sign informed consent
排除标准
- •Pregnant women
- •Contraindication of plasma administration due to history of anaphylaxis during transfusions
结局指标
主要结局
In-hospital mortality
时间窗: 30 days
In-hospital mortality after administration of ABO compatible convalescent plasma or indication (but not plasmapheresis for absence of compatible convalescent plasma) for comparison group
次要结局
- Incidence of renal replacement therapy(30 days)
- Incidece of adverse events(During tranfusion until 24 hours after.)
