Screening of Health-care Workers in an University Hospital for SARS-CoV-2
- Conditions
- Covid19
- Interventions
- Other: Investigation of the prevalence of test positivity
- Registration Number
- NCT04567836
- Lead Sponsor
- University of Milano Bicocca
- Brief Summary
This is an observational prospective study. The aim is to assess the prevalence of test positivity (swab or serological examination) to Coronavirus Disease-2019 (Covid-19) in relation to the duties and related occupational risk.
- Detailed Description
The study protocol provides for a collection of basic data relating to all hospital workers who voluntarily underwent the test (age, sex, type of occupation - doctor / nurse / socio-health / administrative operator; attendance in Covid-19 wards department), IgG outcome (quantitative level) and swab outcome (negative, weakly positive, positive).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- Hospital staff on active duty;
- Age greater than or equal to 18 years;
Failure to consent to serological screening or failure to consent to study participation (there are two different consent)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description The asymptomatic medical staff cohort Investigation of the prevalence of test positivity 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. The symptomatic medical staff cohort Investigation of the prevalence of test positivity The cohort of symptomatic hospital workers who tested positive for the swab includes 250 operators.
- Primary Outcome Measures
Name Time Method Correlation of the positive result of the test with the manifestations of the signs Until the end of the study (approximately 6 months). Description of the positive result of the test (swab or serological examination) with the manifestations of the signs / symptoms collected in the previous months from the attached form in the cohort of positive cases and related negative controls.
Development of COVID Until the end of the study (approximately 6 months). Description of the outcome of positive serological and swab test operators in terms of development of COVID-related symptomatology
Prevalence of test positivity Until the end of the study (approximately 6 months). Desciption of the prevalence of test positivity (swab or serological examination) in relation to the duties and related occupational risk
- Secondary Outcome Measures
Name Time Method Analysis of genomic sequences of the virus Until the end of the study (approximately 6 months). to correlate the virus genomic sequence of asymptomatic but positive serological and swab operators with the available data of the SARS-CoV-2 virus sequences.
Evaluation of the mode of transmission relatively anamnestic data Until the end of the study (approximately 6 months). Evaluate the mode of transmission between relatives by collecting anamnestic data.
The relation between mode of transmission and the available clinical documentation Until the end of the study (approximately 6 months). Assess the mode of transmission between relatives by collecting the available clinical documentation
Evaluation of the test relevance Until the end of the study (approximately 6 months). Evaluate the relevance of tests with greater sensitivity and specificity in the population negative for the throat swab but positive for the serological investigation;
Evaluation of predictive biomolecular markers Until the end of the study (approximately 6 months). Evaluation biomolecular markers that are predictive of susceptibility to infection and predictive of symptomatic infection
The trend over time of the antibody response in subjects positive Until the end of the study (approximately 6 months). Evaluate the trend over time of the antibody response in subjects positive to the serological test and to the swab (both symptomatic and asymptomatic).
Evaluation of the mode of transmission for the use of barriers Until the end of the study (approximately 6 months). Evaluate the mode of transmission between relatives by collecting the barriers used in the home: none, mask and spacing, voluntary isolation.
The frequency of re-infection Until the end of the study (approximately 6 months). Evaluate the frequency of re-infection (symptomatology compatible with COVID and positive swab) in operators who tested positive for serological and swab tests.
Trial Locations
- Locations (1)
ASST Monza-Ospedale San Gerardo
🇮🇹Monza, Italy