IRCT20200416047099N1招募中未知
se of convalescent plasma in the treatment of patients with severe COVID-19 pneumonia
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •Inclusion criteria of plasma donor (1-9) Recovery from 2019-nCoV infection according to clinical and laboratory criteria
- •Pass the at least 28 days after hospital discharge
- •Negative RT-PCR test ( 2 times with 48 h interval)
- •Negative results of serum/plasma for HBV, HCV, HTLV, HIV, and Syphilis
- •ABO, and RH antigens determination
- •Fill informed consent to collect 650-1300 apheresis
- •Inclusion criteria of recipient (11-15)
- •Confirmed the diagnosis of nCoV infection by RT-PCR
- •Respiratory > 30 beats/min
- •PaO2 / FiO2 =300 mmHg
- •Fill informed consent
排除标准
- •Exclusion criteria of plasma donor (2-13)
- •Active respiratory infection symptoms: cough, dyspnea, oxygen requirements during 3 days ago
- •History of Cardiac congestion, pulmonary hypertension, and other situation leading to apheresis failure
- •Bleeding history and anti-coagulant agent therapy
- •HBV vaccination during last week Receiving live-attenuated vaccines including BCG, yellow fever, measles, mumps, polio and typhoid fever during over the past three weeks
- •Receiving IVIG injection, anti-tetanus, and other passive immunization over the past 6 weeks
- •Small pox vaccination or contact with a person who receive Small pox vaccine
- •Undefined loss weight > 4.5 kg, apheresis over the past three months
- •Diagnosis of Dengue fever, Induced abortion, and blood transfusion over the past 6 months
- •Exclusion criteria of recipient (11-14)
- •Pregnancy, breast-feeding
- •Patients with psychosis, severe systemic disease, and malignancy
- •Patients with serious underlying disease for expample hematological disorder, cachexia, active bleeding, malnutrition, cardiovascular, renal, lung, and liver dysfunction
- •Uncontrolled infection
- •Patients who participated in other clinical trialsCoinfection with HIV, Syphilis, Syphilis, tuberculosis, flu infection, adenovirus infection, and other respiratory viral infection
研究者
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