Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
研究概览
简要总结
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.
The objectives of this study are :
- To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.
- To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.
- To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Patient who signed the study consent form
- •Convalescent patient (at least 12 days after the onset of symptoms), having been sampled at Hospices Civils de Lyon for a suspected infection with SARS-Cov-2, confirmed by PCR.
排除标准
- •Patient treated with rituximab
- •Patient treated with immunoglobulins
- •Patient over 18 years old, subject to a legal protection measure (guardianship or trusteeship)
- •Patient deprived of liberty
- •Pregnant or lactating woman
- •Patient not affiliated to a social security scheme or beneficiary of a similar scheme.
结局指标
主要结局
Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
时间窗: 3 weeks
Isolation of immortalized B lymphocyte clones, producer of monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.
次要结局
未报告次要终点