NL-OMON50016已完成3 期
Convalescent plasma from cured coronavirus disease (COVID) patients as a therapy for patients with severe COVID disease (CONCOVID) - CONCOVID
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
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 至 99（—）
入选标准
- •Patients with PCR confirmed COVID disease
- •The most recent PCR positive sample is <96hrs old
- •Patient admitted to the hospital <7 days
- •Age >=18
- •Written informed consent by patient or legal patient representative
- •Tested negative for HIV, HBV, HCV, HEV, HTLV and syfilis
- •A history of COVID infection that was documented by PCR
- •Known ABO-Resus(D) blood group
- •A screening for irregular antibodies with a titer <= 1:32
- •Asymptomatic for at least 14 days
- •Written informed consent regarding the plasmapheresis procedure
排除标准
- •Participation in another intervention trial on the treatment of COVID-19 that
- •falls under the
- •Dutch law human research (WMO)
- •Already on mechanical ventilation for >96hrs
- •IgA deficiency
- •Age <18 years or age >65 years
- •Weight <50 kg
- •Medical history of heart failure
- •History of transfusion with red blood cells, platelets or plasma after
- •01-01-1980
- •History of organ- or tissue transplant
- •A cumulative stay in the United Kingdom of >= 6 months in the period between
- •01-01-1980 and
- •31-12-1996
- •A history of i.v. drug use
- •Insulin dependant diabetes
- •An underlying severe chronic illness (i.e. history of heart failure, cancer
- •Tested positive for HLA- or HNA-antibodies
研究者
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暂停
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