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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387929
• Other study ID #: 1374 IgG COVID-19 HUMANITAS
• Status: Recruiting
• Start date: May 4, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2020
• Source: Istituto Clinico Humanitas
• Contact: Patrizia Meroni, MD
• Phone: 02 82241
• Email: patrizia.meroni[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Italy	Humanitas Rozzano/San Pio X	Rozzano	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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