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临床试验/NCT04425759
NCT04425759Unknown不适用

Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses and Assymptomatic Carriers Among a Cohort of 2,300 Healthcare Workers at the Consorci Sanitari Del Maresme (CSdM)

Hospital de Mataró1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2020年6月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,400
试验地点
1
主要终点
PCR of nasopharyngeal smears on all IgM +

研究概览

简要总结

Observational and prospective study with one year of follow-up of the cohort of workers of the CSdM, including workers of subcontracted companies working in the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and at 3, 6, 9 and 12 months. All CSdM workers will be invited to participate by e-mail and by announcements in the corporate website. A space will be set up on the corporate intranet where workers will be informed about the study, will be able to give their informed consent and will be able to answer an electronic questionnaire regarding socio-demographic, clinical and labour personal characteristics. Once the questionnaire answered, participants will be authorized to schedule a blood extraction. Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG). PCR will be also performed for IgM and IgA positive subjects.

详细描述

  • Study design: observational and prospective study with one year of follow-up of the cohort of workers of the CSdM, including workers of subcontracted companies working in the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and at 3, 6, 9 and 12 months.
  • Aims: to perform a universal test for all the professionals of the Consorci Sanitari del Maresme (CSdM) in order to carry out the following objectives:
  1. Let them know if they have been exposed to the SARS-CoV-2 virus.
  2. Identify asymptomatic carriers of SARS-CoV-2 virus.
  3. Develop an immune map of all the professionals to: a) describe the seroprevalence of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk of infection in CSdM professionals; c) contribute to the improvement of knowledge about the infection and the social and occupational factors that affect its spread; and d) allow in the future to identify the duration of immunity against SARS-CoV-2.
  • Time Frame: 1 year.
  • Study population: all workers from the healthcare centers of the Consorci Sanitari del Maresme will be invited to participate by e-mail and by announcements in the corporate website. A space will be set up on the corporate intranet where workers will be informed about the study, will be able to give their informed consent and will be able to answer an electronic questionnaire regarding socio-demographic, clinical and labour personal characteristics. Once the questionnaire answered, participants will be authorized to schedule a blood extraction.
  • Methods: Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG) and PCR will be also performed for IgM and IgA positive subjects following this algorithm:

Serological study:

  1. Screening the entire population with total CLIA result (IgA, IgM, IgG) to determine negatives.
  2. ELISA for positives with differentiated IgM, IgA and IgG results.
  3. PCR of nasopharyngeal smears on all IgM and IgA + (to determine asymptomatic cases).

There will be other blood samplings and determination points at 3, 6, 9 and 12 months for all the study participants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •All the professionals working at the Consorci Sanitari del Maresme (approximately 2300 subjects).

排除标准

  • 未提供

结局指标

主要结局

PCR of nasopharyngeal smears on all IgM +

时间窗: 1 year

* To detect symptomatic or asymptomatic carriers * New diagnostics of COVID19 confirmed by PCR of nasopharyngeal smears

Antibodies to SARS-CoV2: IgA, IgM, IgG

时间窗: 1 year

* Screening for the entire population with total IgA, IgM, IgG to screen the negatives * ELISA for positives with differentiated IgM+IgA vs IgG specific for SARS-Cov-2 seroprevalence of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk of infection in CSdM professionals; c) contribute to the improvement of knowledge about the infection and the social and occupational factors that affect its spread; and d) allow in the future to identify the duration of immunity against SARS-CoV-2.

次要结局

未报告次要终点

研究者

发起方
Hospital de Mataró
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pere Clave

Director of Research and Academic Development at CSdM

Hospital de Mataró

研究点 (1)

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