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

Unknown status
COVID-19

Diagnostic Test: Detection of anti-COVID-19 antibody level

Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
Italy
Locations

Humanitas Rozzano/San Pio X
Rozzano, Lombardia, Italy

Investigator: Patrizia Meroni, MD
Contact: 0282241
patrizia.meroni@humanitas.it

Contacts

Patrizia Meroni, MD
02 82241
patrizia.meroni@humanitas.it

Istituto Clinico Humanitas
NCT Number
Keywords
Covid-19
Antibody titer
Serological tests
Hospital personnel
MeSH Terms
COVID-19
Antibodies