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Clinical Trials/NCT04387929
NCT04387929
Unknown
Not Applicable

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

Istituto Clinico Humanitas1 site in 1 country6,000 target enrollmentMay 4, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Istituto Clinico Humanitas
Enrollment
6000
Locations
1
Primary Endpoint
SARS-CoV-2 levels of IgG antibodies
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2020
End Date
May 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

SARS-CoV-2 levels of IgG antibodies

Time Frame: 1 year

Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG.

Secondary Outcomes

  • Epidemiology correlations(1 year)
  • SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects(1 year)

Study Sites (1)

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