Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19 (SERASYMPTO)
Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study
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
研究概览
详细说明
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.
The design will be a case control study between
- Cases: SARS-Cov-2 asymptomatic nursing homes employees
- Controls: cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.
研究类型
阶段
- 不适用
联系人和位置
学习地点
-
-
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Paris、法国、75004
- Hotel Dieu Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Common inclusion criteria:
- Age ≥ 18.
- Health care employees working in the EHPAD who consulted in the Hotel Dieu Hospital
- Affiliated with a health insurance
- Informed information and consent
Inclusion Criteria for Cases (asymptomatic COVID-19 patients) :
- Health care workers screened SARS-Cov-2 positive for NASopharyngeal swaths during screening campaigns for EHPAD staff.
- Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.
- Having never developed symptoms of COVID-19 or have developed some symptoms undetected before screening: fever, transient fatigue, rhinorrhea, symptoms that may be mistaken for a common winter cold (no respiratory symptoms or prolonged fever)
Inclusion criteria for controls (symptomatic COVID-19 patients) :
- Health care workers tested positive for polymerase chain reaction assay (PCR) SARS-Cov-2 during screening campaigns for EHPAD staff at the Hotel Dieu.
- Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.
COVID-19 symptoms defined by:
- At least two major signs of COVID-19 among: > fever, cough, chest tightness, bilateral pneumonia, anosmia, loss of taste.
- or a major sign and three minor signs among: headache, severe fatigue, diarrhea, odynophagia, rhinorrhea, suggestive skin signs.
It is part of the database of the virology department of Cochin Hospital (in case of failure to recruit health care workers in the EHPADs).
*Exclusion criteria :
- Refuse to participate or inability to obtain informed consent.
- under guardianship, curators
- negative SARS-COV-2 PCR
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Cases
SARS-Cov-2 asymptomatic nursing homes employees
|
serology at M3 and serology at M6
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|
其他：Controls
cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.
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serology at M3 and serology at M6
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
rate of positive IgG serology
大体时间：month 1-2 post infection
|
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
|
month 1-2 post infection
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
rate of positive IgG serology
大体时间：month 3-6 post infection
|
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
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month 3-6 post infection
|
|
rate of positive immunoglobulin M (IgM) serology
大体时间：month 1-2-3 and 6 post infection
|
positive IgM SARS-Cov-2 serology after infection of asymptomatic employees
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month 1-2-3 and 6 post infection
|
|
rate of neutralizing antibodies
大体时间：month 1-2-3 and 6 post infection
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concentration of neutralizing antibodies
|
month 1-2-3 and 6 post infection
|
|
questionnaire
大体时间：month 1-2-3 and 6 post infection
|
Associated factors with the presence of antibodies
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month 1-2-3 and 6 post infection
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|
re infection
大体时间：through study completion, an average of 8 months
|
of asymptomatic patients with SARS-Cov-2
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through study completion, an average of 8 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Dominique Salmon, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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