NCT04384588Unknown2 期
Investigational- Compassionate Use of Convalescent Plasma From COVID-19 Donors in Oncological and Non-Oncological Patients With Severity Criteria: FALP 001-2020 Trial (FALP-COVID)
Fundacion Arturo Lopez Perez2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
研究概览
简要总结
COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related
详细描述
This is a collaborative, 4 arms , non randomized clinical trial assessing the use of Convalescent Plasma from COVID-19 recovered donors to be used in oncological and non-oncological patients with current severe COVID-19 infection or in patients with risk factors of major complications secondary to COVID-19 infection
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all patients:
- •A. Patient must sign an informed consent to participate in this trial
- •B. Signed consent to participate in this trial must be given not after 14 days from the first day of symptoms COVID-19 related
- •Patients with severity criteria must have any of the following: dyspnea and or respiratory rate >=30 per min and or saturation <= 93% with fraction of inspired oxygen 21% and or ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaFi )<300 and or lung images showing worsening in 24-48 hours
- •Patients without severity criteria but with 2 or more factor risks:
- •A. 50 years or older
- •B. any of the following comorbidities: Diabetes Mellitus, Hypertension, Chronic Obstructive Pulmonary Disease, Chronic Kidney Failure, non-oncological related chronic immunosuppression
- •C. Total bilirubin>1,2 mg/dl or Blood Urea Nitrogen> 20 mg/dl or Lactate Dehydrogenase>245 U/L
- •D. D-dimer > 1mg/L
- •E. Neutrophils 7.3 x 10³ or greater and or Lymphocytes lesser than 0,8 x 10³ µl
- •F. C reactive protein >9,5 mg/dl and ferritin > 300 ug/ml
- •G. Interleukin-6 >7 pg/mL
- •H. antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapy- molecular therapy- oncological surgery during the last 8 weeks
排除标准
- •known allergy to plasma
- •Severe multiple organic failure
- •Active intra brain hemorrhage
- •Disseminated intravascular coagulation with blood products requirements
- •Patient with an adult respiratory distress longer than 10 days
- •patients with active cancer and life expectancy shorter than 12 months according with medical criteria
结局指标
主要结局
in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
时间窗: 1 year
in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
safety of the use of convalescent plasma drom COVID 19 donors
时间窗: 1 year
safety of convalescent plasma from COVID 19 donors (CTCAE V5.0)
次要结局
- Viral load measuring(14 days)
- in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports(through study completion, an average of 1 year)
- Number of days of hospitalization in high complexity facilities after convalescent plasma use(1 year)
- Number of days of hospitalization in intensive care unit after convalescent plasma use(1 year)
- Mortality at 30 days, 90 days, 6 months and 1 year(1 year)
- Number of days of mechanical ventilatory support in patients after convalescent plasma use(1 year)
- Donor Granulocyte Macrophage Colony Stimulating Factor characterization(1 day)
- Total number of days of mechanical ventilatory support(1 year)
- Total number of hospitalization days in patients treated with convalescent plasma(1 year)
- Number of hospitalization days in patients after treatment with convalescent plasma(1 year)
- Donor Tumor Necrosis Factor Alfa characterization(1 day)
- Negativization of COVID 19 load since convalescent plasma use(14 days)
- Donor Interferon Gamma profile characterization(1 day)
- Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)(day 1 of hospitalization)
- Negativization of COVID 19 load since hospitalization(14 days)
- Negativization of COVID 19 load since first reported symptoms COVID-19 related(14 days)
- Donor Interleukin -1 beta characterization(1 day)
- Donor Interleukin-2 characterization(1 day)
- Donor Interleukin-4 characterization(1 day)
- Donor Interleukin-6 characterization(1 day)
- Donor Interleukin-8 characterization(1 day)
- Donor Interleukin-10 characterization(1 day)
- Receptor Interferon Gamma profile characterization(1 day)
- Receptor Granulocyte Macrophage Colony Stimulating Factor characterization(1 day)
- receptor Tumor Necrosis Factor Alfa characterization(1 day)
- receptor Interleukin -1 beta characterization(1 day)
- Receptor Interleukin-2 characterization(1 day)
- Receptor Interleukin-4 characterization(1 day)
- Receptor Interleukin-6 characterization(1 day)
- Receptor Interleukin-8 characterization(1 day)
- Receptor Interleukin-10 characterization(1 day)
研究者
研究点 (2)
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