Efficacy of Convalescent Plasma for the Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Intrahospital mortality from any cause
研究概览
简要总结
Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU
详细描述
Coronavirus infection has been declared by the World Health Organization as a pandemic. In addition to hemodynamic and ventilatory support in the intensive care unit, there is no treatment for COVID-19. Currently proposed treatments (chloroquine, antivirals, immunomodulators, among others) have low quality studies that do not prove efficacy.
Blood or plasma transfusion from convalescent patients (patients who have overcome the disease by generating a competent immune response) has been prescribed for over 100 years. In the last 15 years, convalescent plasma has been studied for the treatment of severe acute respiratory infections of viral origin, such as severe acute respiratory syndrome (SARS), avian influenza, and influenza A (H1N1). Suppressing viremia is one of the possible explanations for the efficacy of convalescent plasma treatment.
For the treatment of COVID-19, there are case series that show a clear improvement in severe patients after administration of convalescent plasma without significant adverse events. At the current crisis of the SARS-CoV-2 pandemic, in which there are no pharmacological treatments that have proven to have any therapeutic effect, it is imperative to assess the efficacy and safety of convalescent plasma transfusion in infected patients.
This is an open, randomized clinical trial with patient allocation in a 2 :1 ratio, plasma: standard management, for a superiority hypothesis. The main objective of this study is to determine the efficacy of convalescent plasma for the treatment of severe COVID-19 infection in terms of decreased in-hospital mortality.
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
- 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
- •For plasma donors:
- •Over 18 years of age
- •Men or nulliparous women with no history of recent abortions or transfusions SARS-CoV-2 infection by PCR in any sample or serological test with a maximum of 60 days from resolution of symptoms.
- •If donation is done within 14 to 28 days after resolution of symptoms, the patient must have a negative PCR test for SARS-CoV-
- •If donation is done after 28 days of resolving symptoms, no negative control test will be required.
- •For plasma recipients:
- •Over 18 years of age
- •SARS-CoV-2 infection confirmed by PCR in any sample
- •Hospitalized in the ICU due to shock or respiratory failure, with less than 24 hours after entering the ICU.
排除标准
- •For plasma donors:
- •Severe SARS-CoV-2 infections with an ICU requirement or those with asymptomatic infections will not be accepted as donors.
- •Nor will a person who has received convalescent plasma as part of the COVID-19 treatment.
- •For plasma receivers:
- •Serious volume overload or other condition that contraindicates plasma transfusion.
- •History of anaphylaxis or serious adverse reaction to plasma.
- •Previous diagnosis of immunoglobulin A deficiency
研究组 & 干预措施
Intervention group
Administration of two units of fresh frozen plasma (between 400 and 500 ml) obtained from convalescent patients from infection by SARS-CoV-2. Convalescent plasma is defined as the plasma of patients who had PCR confirmed SARS-CoV-2 infection, who have recovered clinically, and who have positive antibodies against SARS-CoV-2.
干预措施: Convalescent plasma (Drug)
结局指标
主要结局
Intrahospital mortality from any cause
时间窗: Up to 28 days
Proportion of patients who die while being hospitalized
次要结局
- Length of hospital stay(Up to 60 days)
- Cumulative incidence of adverse events: transfusion reactions (fever, flare), TRALI (transfusion-associated lung injury), TACO (transfusion-related circulatory overload), transfusion- related infections(Up to 28 days)
- Free time for ventilatory support on day 60(Day 60)
- Overall survival at day 60 since hospitalization(Day 60)