A Prospective, Epidemiological, Cohort Study to Assess the Feasibility of Screening Healthy Asymptomatic Workers for the Presence of SARS-CoV-2 by Pharyngeal Swaps and Serology at Baseline, Day 21 and Day 40
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- Immune responses to components of SARS-Cov-2
研究概览
简要总结
This is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2 by pharyngeal swaps and serology at baseline, day 21 and day 40.
详细描述
This study has been designed to assess the feasibility of screening asymptomatic workers and to investigate the extent of infection, as determined by pharyngeal swaps analysis and immune response against the virus and virus specific CD4+ and CD8+ T-cell analysis. Furthermore, the extent to which virus-specific CD4+ and CD8+ T-cells are induced is investigated as well as the persistence of virus-specific memory CD4+ and CD8+ T-cells -especially in asymptomatic infected persons.
In total, approximately up to 500 workers will be enrolled into the trial to have 450 evaluable subjects at the end of the study. There will be three individual cohorts of workers working in different departments: workers from the production area (cohort 1), workers from the laboratory area (cohort 2) and workers working in other areas (cohort 3).
The fraction of asymptomatic or subclinical infections should be determined as well as the kinetics of the immune responses. For each timepoint the difference between the cohorts is investigated. This study also aims to evaluate the impact of sanitary and preventive measures taken within the company during the pandemic situation.
Epidemiological exposure data and biological samples will be systematically collected. The present study is being conducted in line with World Health Organization recommendations to help understanding the epidemiology of SARS-Cov-2.
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
- •Healthy workers asymptomatic for SARS-CoV-2
- •Ability to consent with the study and its procedures
- •Age above 18 years old
- •Full time employee on site at least 3 full working days a week
- •Working in a shared office/lab/manufacturing environment where at least 3 employees are present and/or having frequent contact with others i.e reception area, transportation and delivery areas.
排除标准
- •Workers presenting symptoms that could be signs of a SARS-CoV-2 infection such as:
- •fever ≥38°C
- •muscle ache (myalgia)
- •sore throat
- •runny nose (rhinorrhea)
- •shortness of breath (dyspnea)
- •chest pain
- •other respiratory Symptoms
- •nausea/vomiting
结局指标
主要结局
Immune responses to components of SARS-Cov-2
时间窗: up to visit 3 (day 40)
Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status. Analysis of trends in CD4/CD8 concentrations over time and correlation with immunoglobulin G (IgG) Levels and new assay evaluation.
Swabs for the presence of SARSCoV-2
时间窗: up to visit 3 (day 40)
Evaluation of Swab for the presence of SARS-CoV-2 by PCR and determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status.
次要结局
- Difference between the study groups in anti-SARS-CoV 2 seropositivity status(up to visit 3 (day 40))