NL-OMON22629招募中不适用
A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Erasmus MC
- 入组人数
- 104
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
入选标准
- •18 years or older
- •- Informed consent
- •- B-cell depleted status because one of following:
- •* Prior B-cell depletion therapy (latest administration < 6 months prior to
- •* Common variable immunodeficiency requiring IVIG suppletion
排除标准
- •A potential subject who meets any of the following criteria will be excluded from
- •participation in this study:
- •? Symptoms of respiratory infection at time of inclusion
- •? Anti-SARS-CoV2 antibodies prior to administration of study product
- •? Positive SARS-CoV-2 PCR
- •? Known previous history of transfusion-related acute lung injury
- •? Known IgA deficiency
- •? Liver cirrhosis
- •? Known hypersensitivity to human immunoglobulins
- •? Received anti-SARS-CoV-2 vaccination in the 4 weeks preceding screening or
研究者
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