Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Time elapsed until clinical improvement or hospital discharge
研究概览
简要总结
The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study
详细描述
Eligible patients will be randomized 1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml). The Bayesian multi-arm and multi-stage model will be used, which will allow an interim analysis after the inclusion of 30 patients, with repeated interim analyses for every 30 additional patients. With this, we expect to define not only the efficacy of convalescent plasma, but also the volume of plasma needed if efficacy is proven. The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.
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
- •Age = or > than 18 years; .
- •Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since symptom onset less than 10 days at the time of screening; - . Presence of COVID-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) -
- •Presence of one of the following criteria:
- •Need for> 3L of O2 in the catheter / mask or> 25% in the Venturi mask to maintain O2 saturation> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 <300mmHg If intubated, within 48 hours of orotracheal intubation
- •Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis; - .Participation approval by the research clinician
排除标准
- •Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID-
- •IgA deficiency
- •Presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion
- •Pregnancy or breastfeeding
- •Receipt of immunoglobulin in the last 30 days
- •Presence of significant risk of death within the next 48 hours at clinical discretion.
结局指标
主要结局
Time elapsed until clinical improvement or hospital discharge
时间窗: Follow up until 28 days after transfusion
clinical improvement is defined as the time from the randomization date until the decline of 2 categories on the ordinal scale of 10 categories or hospital discharge (whichever comes first)
次要结局
- Duration of clinical events(Up to 28 days)
- Clinical Status("Day 7", "Day 14" and "Day 28")
- IgG, IgM and IgA titers for SARS-CoV-2(Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups)
- Neutralizing antibodies(0,1,7 14 and 28 days after transfusion and control groups)
- acute adverse events(Up to 12 hours after transfusion)
- SARS-CoV-2 in nasopharyngeal swab(Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups)