Detection of Anti-COVID-19 Antibody Levels in an Hospital Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Cohort Study for the Detection of Anti-COVID-19 Antibody Levels in an Hospital Population

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Detection of anti-COVID-19 antibody level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Subjects absent for any reason during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IgG negative<br>No intervantion. Only antibody mesurment from blood sample | Diagnostic Test: Detection of anti-COVID-19 antibody level<br>* Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.<br>|
| IgG positive, viral load negative<br>No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs | Diagnostic Test: Detection of anti-COVID-19 antibody level<br>* Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.<br>|
| IgG positive, viral load positive<br>No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs | Diagnostic Test: Detection of anti-COVID-19 antibody level<br>* Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 levels of IgG antibodies | Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects | 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. | 1 year | 
| Epidemiology correlations | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Antibody titer, Serological tests, Hospital personnel