Randomized, Open Label, Prospective Study of the Safety and Efficacy of Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The number and proportion of patients with the normal body temperature (≤37.2 C) at the day 1, 2, 3, 4, 5, 6, 7 after the start of therapy
研究概览
简要总结
The clinical trial aims to study the safety and efficacy of transfusion of COVID-19 convalescent hyperimmune plasma for the treatment of moderate and severe forms of COVID-19 disease in comparison with non-convalescent fresh frozen plasma (standard plasma).
详细描述
This is a study of the safety and efficacy of the use of COVID-19 convalescent plasma (from subjects who have recovered from SARS-CoV-2) in the treatment of moderate and severe forms of the SARS-CoV-2 infection. Currently, there are no registered drugs for the treatment of the SARS-CoV-2 infection in the world. The use of hyperimmune plasma is a well-known method used for many decades to treat many dangerous infections. The effectiveness of such a therapy for COVID-19 patients has recently been demonstrated in a number of clinical studies in China. Therefore, we plan to study the feasibility of administering multiple doses of COVID-19 convalescent plasma in comparison with standard plasma to moderate and severe patients with COVID-19.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18-75 years.
- •The presence of COVID-19 infection, confirmed by PCR testing
- •The presence of the COVID-19 pneumonia pattern on the chest HRCT with a damage to more than 25% of the lung parenchyma
- •Morning fever ≥ 38.0 °C over the last three days
- •CRP blood level ≥ 50 mg / ml or ferritin blood level ≥ 600 μg / ml
- •A signed informed consent
排除标准
- •Respiratory index ≤200
- •Contraindications for the transfusion of donor immune plasma or history of prior reactions to blood transfusions
- •Mechanical ventilation
- •The presence of chronic lung diseases with chronic respiratory failure.
- •The need for home continuous oxygen therapy before the onset of current disease.
- •Serum creatinine level higher than 150 μmol / l
- •Pregnancy or breastfeeding
结局指标
主要结局
The number and proportion of patients with the normal body temperature (≤37.2 C) at the day 1, 2, 3, 4, 5, 6, 7 after the start of therapy
时间窗: Days 1, 2, 3, 4, 5, 6, 7
The number and proportion of patients with the normal body temperature (≤37.2 C) at the days 1, 2, 3, 4, 5, 6, 7 after the start of therapy, for the statistical data comparison between the two arms.
次要结局
- Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors(Days 3, 7)
- 30-day mortality rate(30 days)
- Dynamics of the cytokine profile(Days 0, 3, 7)
- Days of stay in the ICU(30 days)
- Days before mechanical ventilation(30 days)
- Dynamics of the level of C-reactive protein(Days 0, 1, 2, 3, 4, 5, 6, 7)
- Days of need for oxygen therapy(30 days)
- Days of hospitalization(30 days)
- Changes of the titer of the SARS-CoV-2 antibodies in the blood plasma of patients(Days 0, 14, 30)