Clinical Efficacy of the Infusion of Donor Plasma, Convalescent From SARS-CoV-2 Infection, to Patients With Recent Infection.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Rate of severity of the disease
研究概览
简要总结
Objectives Primary objectives To assess the superiority or not of the infusion of anti-COVID immune plasma infusion versus a placebo (non-immune plasma) to patients over 65 years of age recently infected with the SARS-CoV-2 coronavirus, to prevent progression to severe forms of the disease with hospital admission.
Secondary objectives To assess if the intervention improves the clinical evolution of the target patient.
- Improvement of the disease.
- Disease deterioration Methodology Design Prospective, randomized (1:1; experimental group: control group), double-blind study, in which the doctors who prescribe the treatments and those who assess the results do not know the treatment received by the patient.
Methods. Patients 65 years of age or older will be included, diagnosed with SARS-CoV-2 coronavirus infection, in which no more than 7 days have elapsed since the onset of symptoms or diagnosis to plasma infusion.All patients included in the study will receive the same standard treatment that is deemed appropriate at any time, understanding as standard treatment that established at any time by the guidelines established.Infusion of 300 cc of convalescent donor plasma from COVID 19, administered within more than 168 hours from the onset of symptoms. For the study to be blind, the infusion of non-convalescent donor plasma, obtained before the start of the epidemic, is required to guarantee the absence of anti-COVID antibodies in the plasma of the control group.
Analysis of data:
Initially, the homogenization of the data referring to the two groups of studies will be evaluated. Classical statistical tests will be applied, such as Wilcoxon's non-parametric tests for the comparison of means of continuous variables, as well as the Chi-square test (or Fisher's exact test) to evaluate the association between categorical variables. The result variables are:
- Hospital admission
- Clinical course
- Mortality
- Complications and/or adverse effects of plasma.
详细描述
Objectives Primary objectives To assess the superiority or not of the infusion of anti-COVID immune plasma infusion versus a placebo (non-immune plasma) to patients over 65 years of age recently infected with the SARS CoV 2 coronavirus, to prevent progression to severe forms of the disease with hospital admission.
Secondary objectives To assess if the intervention improves the clinical evolution of the target patient.
- Improvement of the disease is considered decrease in the WHO scale.
- Disease deterioration is considered ascent of the WHO scale
- It is considered stable disease those cases in which criteria for improvement or deterioration of the disease are not met.
Methodology Design Prospective, randomized (1:1; experimental group: control group), double-blind study, in which the doctors who prescribe the treatments and those who assess the results do not know the treatment received by the patient.
The convalescent plasma will be contrasted with fresh frozen plasma, available at the Basque Transfusion and Tissue Center of the Basque Autonomous Community (CVTTH), obtained before 12/31/2019.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Treatment in the intervention group:
Infusion of 300 cc of convalescent donor plasma from COVID 19, administered within more than 168 hours from the onset of symptoms
Treatment in the control group:
For the study to be blind, the infusion of non-convalescent donor plasma, obtained before the start of the epidemic, is required to guarantee the absence of anti-COVID antibodies in the plasma of the control group.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SARS CoV 2 infection, confirmed by PCR or technique of similar specificity.
- •Symptom onset, or positive PCR (whichever comes first) within 7 days (168 hours) prior to planned plasma infusion.
- •65 years of age or older.
- •All patients, or the guardian appointed by the judge, in the case of recognized judicial incapacity, must sign the informed consent document.
排除标准
- •Less than 65 years of age
- •Symptom onset, or positive PCR (whichever comes first), more than 7 days (168 hours) prior to planned plasma infusion.
- •Severe dementia, or other significant comorbidity, that generates a serious deterioration of the baseline functional status, with a life expectancy of less than 6 months.
- •Participation in another clinical trial or study.
- •History of allergy to amotosalen or psoralens
结局指标
主要结局
Rate of severity of the disease
时间窗: 28 days
Rate of improvement / stable / deterioration of the disease on the 7th and 14th days after plasma infusion.
Rate of of deaths
时间窗: 120 days
Rate of of deaths (in-hospital and out-of-hospital)
Rate of hospital admission
时间窗: 28 days
Rate of hospital admission (among patients whose admission was not indicated prior to plasma infusion
Rate of complications
时间窗: 28 days
Rate of complications and/or adverse effects of plasma.
次要结局
未报告次要终点
研究者
Jose Enrique de la Puerta, MD
Principal Investigator
Hospital Galdakao-Usansolo