Screening of Health-care Workers in an University Hospital: an Observational Prospective Study on the Screening of Hospital Workers for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Correlation of the positive result of the test with the manifestations of the signs
研究概览
简要总结
This is an observational prospective study. The aim is to assess the prevalence of test positivity (swab or serological examination) to Coronavirus Disease-2019 (Covid-19) in relation to the duties and related occupational risk.
详细描述
The study protocol provides for a collection of basic data relating to all hospital workers who voluntarily underwent the test (age, sex, type of occupation - doctor / nurse / socio-health / administrative operator; attendance in Covid-19 wards department), IgG outcome (quantitative level) and swab outcome (negative, weakly positive, positive).
The cohort of hospital workers constitutes a population of particular relevance for the development of appropriate strategies for the surveillance of hospital risk for SARS-CoV-2 infection (relationship to the type of job, clinical evolution) and the available data are very limited.
The asymptomatic staff cohort constitutes the ideal population context to contribute to knowledge of aspects of the spread of the virus.
The limitations of current serological tests are well known, which do not allow to distinguish the acute phase of the infection and therefore the persistence of contagiousness. Similarly, the genomic characteristics of the SARS-CoV-2 virus are not known in asymptomatic but swab positive subjects compared to the virus isolated from symptomatic patients.
In the cohort of operators who tested positive for nasopharyngeal swab (both symptomatic and asymptomatic), the availability of serological tests will allow to evaluate the antibody response over time in relation to the clinical evolution of the infection, and the persistence of a protective titer over time.
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
- 否
入选标准
- •Hospital staff on active duty;
- •Age greater than or equal to 18 years;
排除标准
- •Failure to consent to serological screening or failure to consent to study participation (there are two different consent)
结局指标
主要结局
Correlation of the positive result of the test with the manifestations of the signs
时间窗: Until the end of the study (approximately 6 months).
Description of the positive result of the test (swab or serological examination) with the manifestations of the signs / symptoms collected in the previous months from the attached form in the cohort of positive cases and related negative controls.
Development of COVID
时间窗: Until the end of the study (approximately 6 months).
Description of the outcome of positive serological and swab test operators in terms of development of COVID-related symptomatology
Prevalence of test positivity
时间窗: Until the end of the study (approximately 6 months).
Desciption of the prevalence of test positivity (swab or serological examination) in relation to the duties and related occupational risk
次要结局
- Analysis of genomic sequences of the virus(Until the end of the study (approximately 6 months).)
- Evaluation of the mode of transmission relatively anamnestic data(Until the end of the study (approximately 6 months).)
- The relation between mode of transmission and the available clinical documentation(Until the end of the study (approximately 6 months).)
- Evaluation of the test relevance(Until the end of the study (approximately 6 months).)
- Evaluation of predictive biomolecular markers(Until the end of the study (approximately 6 months).)
- The trend over time of the antibody response in subjects positive(Until the end of the study (approximately 6 months).)
- Evaluation of the mode of transmission for the use of barriers(Until the end of the study (approximately 6 months).)
- The frequency of re-infection(Until the end of the study (approximately 6 months).)