NL-OMON51004已完成不适用
A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines - ConvP/COVig PK/PD study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 18 years or older
- •* Informed consent
- •* B-cell depleted status because one of following:
- •o Prior B-cell depletion therapy (latest administration < 6 months prior to
- •o Immunodeficiency requiring IVIG suppletion
- •* Wantai total Ig antibody optical density (OD) ratio of 2.0 or lower 2 weeks
- •after complete vaccination against COVID-19
排除标准
- •* Symptoms of respiratory infection at time of inclusion
- •* Anti-SARS-CoV-2 antibodies prior to administration of study product > 2.0 OD
- •(Wantai total Ig)
- •* 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 2 weeks preceding screening or
研究者
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