Detection of Anti-COVID-19 Antibody Levels in an Hospital Population
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ClinicalTrials.gov Identifier: NCT04387929 |
Recruitment Status : Unknown
Verified May 2020 by Istituto Clinico Humanitas.
Recruitment status was: Recruiting
First Posted : May 14, 2020
Last Update Posted : May 15, 2020
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 | Diagnostic Test: Detection of anti-COVID-19 antibody level |
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.
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 |

Group/Cohort | Intervention/treatment |
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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. |
- 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.
- 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.
- 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 |
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)
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

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
Contact: Patrizia Meroni, MD | 02 82241 | patrizia.meroni@humanitas.it |
Italy | |
Humanitas Rozzano/San Pio X | Recruiting |
Rozzano, Lombardia, Italy, 20089 | |
Contact: Patrizia Meroni, MD 0282241 patrizia.meroni@humanitas.it |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Antibody titer Serological tests Hospital personnel |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Antibodies Immunologic Factors Physiological Effects of Drugs |