Detection of Anti-COVID-19 Antibody Levels in an Hospital Population
- Conditions
- COVID-19
- Interventions
- Diagnostic Test: Detection of anti-COVID-19 antibody level
- Registration Number
- NCT04387929
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6000
- 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
- Subjects absent for any reason during the study period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IgG positive, viral load positive Detection of anti-COVID-19 antibody level No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs IgG negative Detection of anti-COVID-19 antibody level No intervantion. Only antibody mesurment from blood sample IgG positive, viral load negative Detection of anti-COVID-19 antibody level No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs
- Primary Outcome Measures
Name Time Method SARS-CoV-2 levels of IgG antibodies 1 year Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG.
- Secondary Outcome Measures
Name Time Method Epidemiology correlations 1 year The association between the antibody value and potential protective or risk factors of the subject participating in the study such as age, clinical history, vaccination history, workplace, professional category, etc.
SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects 1 year Measurement of the viral load of the nasopharyngeal swab in antibody test positive subjects and the correlation between the antibody titer and virus positivity or negativity.
Trial Locations
- Locations (1)
Humanitas Rozzano/San Pio X
🇮🇹Rozzano, Lombardia, Italy