Use of COVID-19 Convalescent Plasma in the Patients Infected With COVID-19 (SARS-CoV-2) - Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Participants With Oxygenation Free Days
研究概览
简要总结
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
详细描述
There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for donation according to the Institutional protocol. Recipients will be COVID-19 patients requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be infused and recipients will be followed up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Blood donors:
- •Age: >18 and <60 years
- •Body weight : >55 kg
- •Confirmed previous SARS CoV-2 infection
- •Minimum 28 days after the last symptom or finishing of the isolation, or
- •21 day without symptoms from the date of the negative SARS CoV-2 test
- •Written informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- •Concentration of COVID-19 IgG antibodies more than 5 AU/ml (Because measurement of neutralizing antibody titers is not available now, storing of retention sample from the convalescent plasma donation is performed for determining antibody titers at a later date)
- •Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- •Individuals who meet all regular voluntary donor eligibility requirements
- •Patients/recipients:
- •Age: >18 years
- •Admitted to an acute care facility for the treatment of COVID-19 complications
- •Patients with severe or immediately life-threatening COVID-19, or
- •Patients who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
- •Informed consent provided by the patient or healthcare proxy
排除标准
- •Blood donors:
- •Age : <18 or >60 years
- •Female subjects who are pregnant
- •HIV1,2 hepatitis B,C or syphilis infection
- •Donors ineligible for regular voluntary blood donation
- •Patients/recipients:
- •Age : <18 years
- •Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
- •Patients who received in the past 30 days immunoglobulin therapy
- •Females who are pregnant or breastfeeding
结局指标
主要结局
Number of Participants With Oxygenation Free Days
时间窗: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of participants without oxygenation support after receiving convalescent plasma
ICU Admission
时间窗: 28 days after transfusion or until hospital discharge (whichever comes first)
Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.
Number of Participants With Serious Adverse Events
时间窗: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of participants with serious adverse events during the study protocol
Duration of Oxygenation Support
时间窗: 28 days after transfusion or until hospital discharge (whichever comes first)
The total number of days patients required respiratory support.
Hospital Length of Stay (LOS)
时间窗: 28 days after transfusion or until hospital discharge (whichever comes first)
Total number of days patients were admitted to the hospital after convalescent plasma transfusion.
次要结局
- Type of Respiratory Support(28 days after transfusion or until hospital discharge (whichever comes first))
- Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery(28 days after transfusion or until hospital discharge (whichever comes first))