Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- rate of positive IgG serology
研究概览
简要总结
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2).
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection
详细描述
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris, France, where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of SARS-Cov-2.
Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.
The main objective of this study is to describe the SARS-Cov-2 asymptomatic employees with positive immunoglobulin G (igG) serology at month 1-2 post infection.
Secondary objectives are
- To describe the proportion of asymptomatic persons with SARS-Cov-2 antibodies month 3 and 6 post infection
- To compare the proportion of persons with SARS-Cov-2 antibodies between asymptomatic and asymptomatic carriers at M1-2 post infection, M3 and M6 post infection
- To determine the factors associated with the appearance of antibodies ( viral load, age, sex, previous history, habitus..)
- To study the neutralizing capacities and immune-profiling of SARS-Cov-2 antibodies in vitro
- To evaluate the occurrence of Coronavirus Disease 2019 (COVID-19) reinfections in asymptomatic carriers during the second wave.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
rate of positive IgG serology
时间窗: month 1-2 post infection
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
次要结局
- rate of positive IgG serology(month 3-6 post infection)
- questionnaire(month 1-2-3 and 6 post infection)
- rate of positive immunoglobulin M (IgM) serology(month 1-2-3 and 6 post infection)
- rate of neutralizing antibodies(month 1-2-3 and 6 post infection)
- re infection(through study completion, an average of 8 months)