Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 950
- 试验地点
- 4
- 主要终点
- IgA specific cells of SARS
研究概览
简要总结
The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •age ≥ 18 years,
- •patients with confirmed SARS-Cov2 infection (RT PCR positive)
- •or patients suspected (evocative chest scanner)
- •OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers)
- •OR patients Non exposure to SARS-Cov2 volunteer subjects (general population)
排除标准
- •pregnant or breastfeeding female
结局指标
主要结局
IgA specific cells of SARS
时间窗: At 7 days
Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later
次要结局
- OMS progression scale(At 7 days)