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

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ClinicalTrials.gov Identifier: NCT04387929
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: Detection of anti-COVID-19 antibody level

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Observational Cohort Study for the Detection of Anti-COVID-19 Antibody Levels in an Hospital Population
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IgG negative
No intervantion. Only antibody mesurment from blood sample
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.

IgG positive, viral load negative
No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs
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.

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. SARS-CoV-2 viral load in nasopharyngeal swab of IgG positive subjects [ Time Frame: 1 year ]
    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.

  2. Epidemiology correlations [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Personnel of Humanitas Group including:

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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387929


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

Locations
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Italy
Humanitas Rozzano/San Pio X Recruiting
Rozzano, Lombardia, Italy, 20089
Contact: Patrizia Meroni, MD    0282241    patrizia.meroni@humanitas.it   
Sponsors and Collaborators
Istituto Clinico Humanitas
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT04387929    
Other Study ID Numbers: 1374 IgG COVID-19 HUMANITAS
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Clinico Humanitas:
COVID-19
Antibody titer
Serological tests
Hospital personnel
Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs