Screening of Health-care Workers in an University Hospital for SARS-CoV-2
NCT ID: NCT04567836
Last Updated: 2022-04-29
Study Results
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Basic Information
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COMPLETED
260 participants
OBSERVATIONAL
2020-07-09
2020-09-18
Brief Summary
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Detailed Description
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The cohort of hospital workers constitutes a population of particular relevance for the development of appropriate strategies for the surveillance of hospital risk for SARS-CoV-2 infection (relationship to the type of job, clinical evolution) and the available data are very limited.
The asymptomatic staff cohort constitutes the ideal population context to contribute to knowledge of aspects of the spread of the virus.
The limitations of current serological tests are well known, which do not allow to distinguish the acute phase of the infection and therefore the persistence of contagiousness. Similarly, the genomic characteristics of the SARS-CoV-2 virus are not known in asymptomatic but swab positive subjects compared to the virus isolated from symptomatic patients.
In the cohort of operators who tested positive for nasopharyngeal swab (both symptomatic and asymptomatic), the availability of serological tests will allow to evaluate the antibody response over time in relation to the clinical evolution of the infection, and the persistence of a protective titer over time.
Methods and study design
1. The cohort of symptomatic hospital workers who tested positive for the swab includes 250 operators. The cohort will be evaluated as a prospective epidemiological study;
2. The cohort of asymptomatic / paucisymptomatic operators will include the cohort of operators who will test positive in the serological analysis. From the entire population of hospital workers (over 3000), three controls will be identified for each operator who tested positive for the serological test on the same day and are negative for the serological test. Considering the positive percentage of 5.5% in the serological survey (from the first epidemiological data reported at the ASST of Monza), the positive screening cohort and the control cohort of about 480 are estimated at about 160.
3. The serological test that will be used is the one required by the indication of the Circular G1.2020.00117959 of 22 April 2020. It is a test with the CLIA method designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS virus "spike" protein -CoV-2, selected for its ability to provide specificity for SARS-CoV-2 compared to other Coronaviruses.
The product has been designed to meet the need to identify in the population those who have already been infected with the virus, whose diagnosis has not been made through the execution of a swab and a molecular diagnostic test.
4. The questionnaire will be administered to all operators.
Data anonymization Health worker will be identified with an 8-digit code followed by the letters OS and the year of collection (e.g. 00000001 OS / 2020); in biological sampling the laboratory will identify the patient with the same code and that will be the linkage code between the database and the bio-bank because it is unique for each worker at the ASST in Monza.
Biological studies
The fields of research in the biological field that the protocol aims to pursue are listed below:
1. Characterizing the SARS-CoV-2 genome in relation to the characteristics of the hospital workers from which the virus is extracted and sequenced is relevant for knowing the functional mechanisms of the virus in relation to the host - both for clinical and diagnostic purposes, as well as for predict virus mutations and related clinical response in view of a second SARS-CoV-2 epidemic;
2. Evaluate the relevance of tests with greater sensitivity and specificity in the population negative for the throat swab but positive for the serological investigation;
3. Study of biomolecular markers of COVID-19 infection with the aim of identifying the basis of the different susceptibility in relation to age, sex and the presence of co-morbidities;
4. Evaluate metabolic biochemical markers of resistance to viral infection in a subgroup of hospital workers with positive swab and in a subgroup with positive antibody test but negative swab to be evaluated at the first available sample and after at least 3 months to allow 27 hydroxycholesterol to return at the concentration prior to infection.
Statistic analysis Central tendency and dispersion measures will be used for descriptive analyzes. The percentage of positive subjects (serological and / swab) will be calculated as the number of positive subjects on the total number of participating subjects. The percentage of immune subjects will be calculated as the number of subjects with IgG immunoglobulins out of the total number of participants.These percentages will also be calculated for age and sex groups and for each characteristic considered relevant.
The logistic regression model will be used to identify demographic / social variables of predisposition to positivity.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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The asymptomatic medical staff cohort
The cohort of asymptomatic / paucisymptomatic operators will include the cohort of operators who will test positive in the serological analysis.
From the entire population of hospital workers (over 3000), three controls will be identified for each operator who tested positive for the serological test that were analyzed on the same day and were negative for the serological test.
Investigation of the prevalence of test positivity
The study consists of an investigation by means of a prospective observational study with the aim of assess the prevalence of test positivity (swab or serological examination) ti covid-19 in relation to the duties and related occupational risk.
It is used CLIA method test designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus "spike" protein, selected for their ability to provide specificity for SARS-CoV-2 compared to other Coronaviruses .
The symptomatic medical staff cohort
The cohort of symptomatic hospital workers who tested positive for the swab includes 250 operators.
Investigation of the prevalence of test positivity
The study consists of an investigation by means of a prospective observational study with the aim of assess the prevalence of test positivity (swab or serological examination) ti covid-19 in relation to the duties and related occupational risk.
It is used CLIA method test designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus "spike" protein, selected for their ability to provide specificity for SARS-CoV-2 compared to other Coronaviruses .
Interventions
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Investigation of the prevalence of test positivity
The study consists of an investigation by means of a prospective observational study with the aim of assess the prevalence of test positivity (swab or serological examination) ti covid-19 in relation to the duties and related occupational risk.
It is used CLIA method test designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus "spike" protein, selected for their ability to provide specificity for SARS-CoV-2 compared to other Coronaviruses .
Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years;
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Responsible Party
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Locations
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ASST Monza-Ospedale San Gerardo
Monza, , Italy
Countries
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References
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Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
Hunter E, Price DA, Murphy E, Schim van der Loeff I, Baker KF, Lendrem D, Lendrem C, Schmid ML, Pareja-Cebrian L, Welch A, Payne BAI, Duncan CJA. First experience of COVID-19 screening of health-care workers in England. Lancet. 2020 May 2;395(10234):e77-e78. doi: 10.1016/S0140-6736(20)30970-3. Epub 2020 Apr 22. No abstract available.
Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020 Jun 9;323(22):2249-2251. doi: 10.1001/jama.2020.8259. No abstract available.
Civra A, Colzani M, Cagno V, Francese R, Leoni V, Aldini G, Lembo D, Poli G. Modulation of cell proteome by 25-hydroxycholesterol and 27-hydroxycholesterol: A link between cholesterol metabolism and antiviral defense. Free Radic Biol Med. 2020 Mar;149:30-36. doi: 10.1016/j.freeradbiomed.2019.08.031. Epub 2019 Sep 13.
Other Identifiers
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STORM-HCW
Identifier Type: -
Identifier Source: org_study_id
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