Observational Cohort Study for the Detection of Anti-COVID-19 Antibody Levels in an Hospital Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 levels of IgG antibodies
研究概览
简要总结
COVID-19 (SARS-CoV-2) infection in health professionals represent a significant criticality both for the risk of spreading the disease and for the organizational aspects that follow. The objective of the study is to evaluate the spread of COVID-19 virus within the hospital population of Humanitas through the monitoring of the levels of IgG antibodies. Moreover, viral load will be measured by RT-PCR in the subgroup positive to IgG antibodies.
详细描述
The Coronavirus identified in Wuhan, China, for the first time in late 2019 is a new viral strain that has never previously been identified in humans. It has been called SARS-CoV-2 and the respiratory disease that causes COVID-19. SARS-CoV-2 infection in health professionals has represented and continues to represent a significant criticality both for the risk of spreading the disease and for the organizational aspects that follow.
Currently the gold standard for the non-invasive diagnosis of COVID-19 is the detection of the viral genome by RT-PCR. However, despite the high specificity, this technique has a low sensitivity and can produce false negative samples. Furthermore, detection of the viral genome is indicative of active infection and fails to identify subjects previously exposed to the virus who have passed the infection asymptomatically. Serological tests can detect the presence of anti-SARS-CoV-2 antibodies in blood or serum samples and, depending on the type of antibody detected, identify the subjects in the active phase of the infection and after the resolution of the infection, the whose diagnosis was not made by performing a swab.
We will evaluate the actual spread of the SARS-CoV-2 virus within the hospital personnel of Humanitas through the monitoring of the levels of IgG antibodies. Moreover, viral load will be measured by RT-PCR of nasopharyngeal swabs in the subgroup positive to IgG antibodies. Secondary endpoints are: visualize the trend of the antibody value at 3, 6 and 12 months; correlation between the antibody titer in test positive subjects and the viral load of the nasopharyngeal swab; identification of predictive variables of susceptibility to viral SARS-CoV2 infection.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age> 18 years old
- •work for the Humanitas Group (Rozzano / San Pio X, Humanitas Gavazzeni, Humanitas Mater Domini, Humanitas University, Humanitas Medical Care)
- •Work activity in the Humanitas Group for at least 3 months among which, for example:
- •Healthcare Staff (Doctors, Nurses, OSS) Technical Staff (Biologists, Radiology Technicians, Laboratory Technicians, etc.) PARC staff and Staff Staff Research Internship students of Hunimed Contract staff (e.g. transport and sanitation services)
- •Signature of informed consent
- •Compilation of the anamnestic questionnaire
排除标准
- •Subjects absent for any reason during the study period
结局指标
主要结局
SARS-CoV-2 levels of IgG antibodies
时间窗: 1 year
Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG.
次要结局
- Epidemiology correlations(1 year)
- SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects(1 year)
