COPLA Study: Treatment of Severe Forms of COronavirus Infection With Convalescent PLAsma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
COVID-19 disease has become a very serious global health problem. Treatments for severe forms are urgently needed to lower mortality. Any procedure that improves these forms should be considered, especially those devoid of serious side effects.There is not enough published information on the use of allogeneic convalescent plasma (ACP) in the treatment of severe forms of COVID-19. The use of ACP can be combined with other treatments and has very few adverse effects. It takes 10-14 days for SARS-CoV2-infected patients to produce virus-neutralizing antibodies: within that time they can develop serious complications and die. Injecting PAC into patients with severe forms of COVID-19 shortens the period of risk while the patient produces the antibodies.
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
- •Patients with SARS-CoV2 infection who have had a serious evolution and are in an ICU
- •With or without ventilatory assistance
- •Treated or not with hydroxychloroquine 200 mg. every 12 hours
- •Indistinct sex
- •Older than 18 years
- •Signed informed consent
排除标准
- •Patients treated with the following medications: azithromycin, ritonavir / lopinavir, remdesivir, interferons, ruxolinitib, tocilizumab.
- •Patients with severe kidney failure who require replacement therapy.
结局指标
主要结局
Overall survival
时间窗: 15-30 days
Patients survival after therapy
Lung injury
时间窗: 7 days
PaO2/FiO2 relation
次要结局
- Adverse reactions to plasma(7 days)
研究者
Guillermo J. RUIZ-ARGÜELLES
Dr. Guillermo J. Ruiz-Argüelles
Centro de Hematología y Medicina Interna