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

I

Istituto Clinico Humanitas

Status

Unknown

Conditions

COVID-19

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04387929
1374 IgG COVID-19 HUMANITAS

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,000 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

6,000 participants in 3 patient groups

IgG negative
Description:
No intervantion. Only antibody mesurment from blood sample
Treatment:
Diagnostic Test: Detection of anti-COVID-19 antibody level
IgG positive, viral load negative
Description:
No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs
Treatment:
Diagnostic Test: Detection of anti-COVID-19 antibody level
IgG positive, viral load positive
Description:
No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs
Treatment:
Diagnostic Test: Detection of anti-COVID-19 antibody level

Trial contacts and locations

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Central trial contact

Patrizia Meroni, MD

Data sourced from clinicaltrials.gov

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