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

NCT ID: NCT04387929

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2021-05-30

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IgG negative

No intervantion. Only antibody mesurment from blood sample

Detection of anti-COVID-19 antibody level

Intervention Type: DIAGNOSTIC_TEST

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

IgG positive, viral load negative

No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs

Detection of anti-COVID-19 antibody level

Intervention Type: DIAGNOSTIC_TEST

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

IgG positive, viral load positive

No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs

Detection of anti-COVID-19 antibody level

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Rozzano/San Pio X

Rozzano, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Patrizia Meroni, MD

Role: CONTACT

patrizia.meroni@humanitas.it

02 82241

Facility Contacts

Patrizia Meroni, MD

Role: primary

patrizia.meroni@humanitas.it

0282241

References

Levi R, Azzolini E, Pozzi C, Ubaldi L, Lagioia M, Mantovani A, Rescigno M. One dose of SARS-CoV-2 vaccine exponentially increases antibodies in individuals who have recovered from symptomatic COVID-19. J Clin Invest. 2021 Jun 15;131(12):e149154. doi: 10.1172/JCI149154.

Reference Type: DERIVED

PMID: 33956667 (View on PubMed)

Other Identifiers

1374 IgG COVID-19 HUMANITAS

Identifier Type: -

Identifier Source: org_study_id