SARS-CoV-2 Seroprevalence Among Adults People Living in Jail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,044
- 试验地点
- 2
- 主要终点
- Determination of the immunological parameters (Immunoglobins G) of the SARS-CoV-2 infection
研究概览
简要总结
"Background France counted on January 1, 2020, 70,651 people detained, for 61,080 places. Overcrowding in detention is considered as risk factor for infectious diseases transmission, such as respiratory infections. The prison environment represents a confined environment, which could protect prisoners from possible external contamination. If one or more inmates were infected through visiting rooms, officers working in detention, or newly incarcerated people, an epidemic could spread more quickly in the prison community. Thus, few cases of COVID-19 were observed among the subjects in detention with a few weeks delay compared to the free world. However, detention conditions make it more difficult to detect suspicious cases. On the other hand, carrying out diagnostic tests is structurally more difficult to carry out there. Thus, given the plurality of clinical presentations, the non-optimal sensitivity of the SARS-CoV-2 RT-PCR, and the difficulty in carrying out diagnostic tests, it is today difficult to have a precise idea of the number of prisoners having encountered SARS-CoV-2. It is also a population that is not taken into account in the large seroprevalence studies currently conducted in the general population. In order to estimate the number of prisoners exposed to SARS-CoV-2 and in the absence of data currently available in the medical literature, a seroprevalence study in this at risk and little studied population would bring new data to the medical community.
Hypothesis In adult subjects living in penal establishments in Ile de France, the seroprevalence of SARS-CoV-2 would be lower compared to the general population.
Material and method Open multicenter cross-sectional study carried out in the 11 penal establishments of Ile de France. A sampling of 3,500 inmates stratified over the 16 detention areas concerned will be carried out. The inclusion criteria will be detained subjects who have expressed their consent to participate in the research, aged 18 to 80 years. Each selected detainee will be invited to the health unit to perform a venous blood test for anti-SARS-CoV-2 antibodies. The goal is to take 2,500 blood samples (30% expected refusal rate). Each sample will be analyzed in the virology laboratory at P. Brousse hospital.
Expected results Obtain an assessment of the seroprevalence of SARS-CoV-2 in prisons to determine the exposure of detained persons. This assessment will make it possible to undertake public health actions and to propose the implementation of group protection measures such as vaccination if this is soon available.
详细描述
"
- Scientific justification for the research
o Current knowledge
SARS-CoV-2, a new coronavirus infecting human, is responsible for the COVID-19 pandemic. The virus is transmitted either directly through the projection of contaminated droplets during a cough or sneeze, or indirectly through contact via an inert contaminated surface. The recent occurrence of the COVID-19 epidemic and the originality of the situation, both nationally and internationally, do not currently allow data describing the epidemic in prison, nor elements characterizing it the seroprevalence of SARS-CoV-2 in detention.
The medical literature currently reports some reflections on the challenges of SARS-CoV-2 infection in prisoners. A team recently reported an epidemic of COVID-19 in prison in China3, which involved more than 500 cases including male and female prison staff and detainees.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Detained woman appearing on the lists supplied by the penitentiary establishments or detained man drawn by lot from the lists supplied by the penitentiary establishments.
- •Age from 18 to 80 years old.
- •Free and informed consent signed."
排除标准
- •Subject likely not to respect the terms of the study
- •Persons who are placed under legal protection
- •Person released from detention between the day of selection and the day of the planned consultation
- •Person who are not attending the inclusion consultation after two invitations
- •Patient who do not speaking French and are not accompanied by a translator
- •Pregnant and lactating women
结局指标
主要结局
Determination of the immunological parameters (Immunoglobins G) of the SARS-CoV-2 infection
时间窗: 7 days
It's obtained from ELISA tests carried out on blood samples. A subject will be considered to have been infected with the SARS-CoV-2 virus if anti-SARS-CoV-2 IgGs are detected in his blood sample.
次要结局
- Symptoms suggestive of COVID-19(7 days)
- Factors assumed to be related to infection with SARS-CoV-2 and the occurrence of moderate to severe forms of COVID-19(7 days)