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临床试验/NCT04480632
NCT04480632Unknown2 期

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

Fundación Cardiovascular de Colombia1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年8月1日最近更新:
适应症

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

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.)

研究者

发起方
Fundación Cardiovascular de Colombia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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