EUCTR2021-000864-32-NL进行中（未招募）1 期
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 PKPD study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •18 years or older
- •Written informed consent
- •? B-cell depleted status because one of following:
- •o Prior B-cell depletion therapy (latest administration < 6 months prior to inclusion)
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
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
- •Known hypersensitivity to human immunoglobulins
- •Liver cirrhosis
- •Received anti-SARS-CoV-2 vaccination in the 2 weeks preceding screening or between screening and baseline
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