Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 3
- 主要终点
- Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
研究概览
简要总结
There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode.
Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •SARS-CoV-2 confirmed by RT-PCR
- •Adults > 18 years
- •Signed consent form
- •Affiliated to the French health system
排除标准
- •Pregnant women
- •Hospitalized patients
- •Individuals subject to legal protection
- •Imprisoned individuals
- •Individuals who have expressed an opposition to participate, or who do not wish to donate blood samples
研究组 & 干预措施
RT-PCR confirmed COVID-19 patients
RT-PCR confirmed patients included in the NOSO-COR study are invited six and 12 months after the initial infection to provide blood (41.5mL in total), salivary and nasopharyngeal samples and to complete a questionnaire. Each visit is expected to take about one hour.
干预措施: Collection of blood, salivary and nasopharyngeal samples. (Other)
结局指标
主要结局
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
时间窗: Month 12
To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients 12 months after laboratory-confirmed diagnosis of SARS-CoV-2
Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
时间窗: Month 6
To describe the immune response to SARS-CoV-2 infection by measuring the level of IgG and IgM in the blood of patients six months after laboratory-confirmed diagnosis of SARS-CoV-2
次要结局
未报告次要终点