COVID-19 Study of the Serological Response Against the SARS-CoV-2 Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,971
- 试验地点
- 4
- 主要终点
- Antibodies against the SARS-CoV-2 virus in serum at inclusion
研究概览
简要总结
This research proposes to study a large healthy population active for the presence of antibodies directed against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus and this over time.
After verification of the inclusion criteria and information by the coordinating investigative doctor, the volunteers sign a written consent. A nurse will take blood samples under safe conditions compatible with the pandemic period and while respecting the protection of the volunteer's personal data.
The blood samples will be taken at 4 times for Institute Curie and Institute Pasteur: T0 (day of inclusion), between 6 weeks and 3 months ,6 months and 12 months post-inclusion.
Each blood sample consists of a collection of 5 mL of blood in a dry tube. The serum samples will be extracted and collected prospectively from the blood samples.
The nasopharyngeal swabs will be performed at 3 times: , between 6 weeks and 3 months, 6 months and 12 months post-inclusion for Institute Curie staff who have had at least one of the following four criteria on the sample or questionnaire carried out at T0:
- have had RT-PCR+
- and/or presence of antibodies at the 95% threshold
- and/or anosmia/ageusia
- and/or digestive syndrome with associated respiratory signs. In case of infection between sampling times, if the volunteer meets one of the four criteria above, a nasopharyngeal swab will be performed during the following visits.
The nasopharyngeal swab shall also be proposed to volunteers not meeting the 4 above listed criteria in order to have a control group (about 100 volunteers) for future statistical analyses.
If the volunteers accept, naso-pharyngeal swab shall be performed between 6 weeks and 3 months, 6 months and 12 months after inclusion.
For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) between 2 sampling times already planned in the flow chart, blood samples and nasopharyngeal swabs shall be performed.
Those shall be performed if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks.
The blood samplings and nasopharyngeal swabs will be performed at 4 times for Institute Pasteur personnel: at T0 (inclusion day), between 6 weeks and 3 months, at 6 months and 12 months post-inclusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Person, adult volunteer outside of any acute infectious episode with SARS-CoV-2* (see paragraph indication), working at the Institute Curie and able to exercise their professional activity on one of the 3 sites of the Institute Curie: Paris, Orsay or Saint Cloud, or on the Campus of the Institute Pasteur.
- •Person aged 18 or over.
- •Information and consent of the person to the procedures related to the study (cf. information note / consent).
- •From November 2020, person having presented at least one of the following criteria since January 2020:
- •A positive diagnostic test for SARS-COV-2 by PCR on a nasopharyngeal sample or antigenic test,
- •A positive SARS-CoV-2 serology,
- •An anosmia or / and an ageusia,
- •A respiratory infection ** associated with digestive signs **
- •whatever the working methods during confinement * Subjects who are not showing active SARS-CoV-2 infection are considered volunteers at the time of inclusion: people with no clinical signs ** suggestive of SARS-CoV-2 infection at the time of collection or having had an end of symptoms for more than 7 days [1].
- •** fever, fatigue, cough, shortness of breath, difficulty to breath, loss of taste or smell, headache, body aches, conjunctivitis or cold, digestive problems (vomiting, diarrhea), whether or not the signs led to sick leave, treatment and / or hospitalization [2].
排除标准
- •Declaration by the subject of signs suggestive of Coronavirus Infectious Disease 2019 (COVID-19) infection with SARS-CoV-2 in progress or for which the end of symptoms dates from less than 7 days
- •Inability to submit to study monitoring for geographic, social or psychological reasons
结局指标
主要结局
Antibodies against the SARS-CoV-2 virus in serum at inclusion
时间窗: 1 day
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 1 month
时间窗: 1 month
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 3 months
时间窗: 3 months
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 6 months
时间窗: 6 months
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 12 months
时间窗: 12 months
Detection of antibodies against the SARS-CoV-2 virus with serological tests
次要结局
- Comparative performance of anti-SARS-CoV-2 antibody detection techniques(9 months)
- Prevalence of immune subjects for SARS-CoV-2(3 months)
- Nature and quantity of anti-SARS-CoV-2 antibodies(3 months)
- Evolution of the different antibodies against the SARS-CoV-2 virus over time.(6 months)
- Prevalence of Anti-covid IgA response in the nasal mucosa(6 months)