An observational study in COVID-19, sponsored by Istituto Clinico Humanitas. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by Istituto Clinico Humanitas · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
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)
Exclusion Criteria:
No intervantion. Only antibody mesurment from blood sample
Diagnostic Test: Detection of anti-COVID-19 antibody level
No intervantion. Only antibody mesurment from blood sample and viral load from nasopharyngeal swabs
Diagnostic Test: Detection of anti-COVID-19 antibody level
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
Measurement of the temporal trend of the antibody value of anti-SARS-CoV-2 neutralizing IgG.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Istituto Clinico Humanitas