PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Transfusion-related Serious Adverse Events
研究概览
简要总结
Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.
Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.
详细描述
The study protocol can be found in:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
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
- •Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
- •Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:
- •Respiratory frequency >22
- •O2 saturation ≤93%
- •PaO2 50mmHg
- •PaO2/FiO2 <300
- •Or critical disease with one or more of the following criteria:
- •Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
- •Inform consent signed by patient or direct family member.
排除标准
- •Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
- •Multiorgan failure, defined by a SOFA score of >5
- •hemodynamically unstable, with mean arterial pressure <60 mmHg, refractory to vasopressors use
- •Uncontrolled concomitant infection
- •Disseminated intravascular coagulation
- •Myocardial infarction
- •Acute coronary disease
- •Patient on dialysis
- •Intracranial bleeding active within the last 7 days
- •Pregnancy
结局指标
主要结局
Transfusion-related Serious Adverse Events
时间窗: 14 days after randomization
Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2
次要结局
- All-cause in-hospital mortality(30 days after randomization)
- Length of hospital stay(30 days after randomization or until hospital discharge, whatever comes first)
- Length of ICU stay(30 days after randomization or until hospital discharge, whatever comes first)
- Clinical Improvement at 14 days(At 3, 14 and 30 days after randomization)
- Duration of mechanical ventilation(30 days after randomization or until hospital discharge, whatever comes first)
- Need of invasive mechanical ventilation(30 days after randomization or until hospital discharge, whatever comes first)