SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak

Study Overview
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Brief Summary
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A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19). This study is a monocentric interventional prospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel. To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5. To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.

Official Title
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SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak

Conditions
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Sars-CoV2

Intervention / Treatment
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* Diagnostic Test: Serological testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult employee of the UZ Brussel who provided a signed informed consent to participate in the study. Exclusion Criteria: UZ Brussel employees whose contract expires within 6 months of study initiation, with the exception of resident trainees (if training continues in another hospital, resident trainees will be asked to perform the last sampling when leaving the UZ Brussel). Staff not active during the inclusion period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: General arm<br>All patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points | Diagnostic Test: Serological testing<br>* Antibody testing for Sars-COV-2 antibodies in blood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprevalence | - To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel at day 0 (i.e. at beginning of the study, planned early May 2020), month 2 and month 5. | Change from baseline to 2 months and 5 months timepoint | 
| seroconversions | - To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months. | Change from baseline to 2 months and 5 months timepoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of definite cases | - To document the incidence of new definite cases of COVID-19 (based on self-reported positive PCR testing on nasopharyngeal swab) among employees of the UZ Brussel over a period of five months. | Change from baseline to 2 months and 5 months timepoint | 
| Incidence of probable cases | - To document the incidence of new probable cases of COVID-19 (based on study questionnaire) among employees of the UZ Brussel over a period of five months. | Change from baseline to 2 months and 5 months timepoint | 
| Antibody kinetics | - To document the SARS-CoV-2 antibody kinetics after confirmed and probable COVID-19. Specifically (1) electrostatic interactions, (2) dispersion forces, (3) hydrogen bonds, and (4) hydrophobic interactions. | Change from baseline to 2 months and 5 months timepoint | 
| Potential work-related risk factors | - To investigate potential work-related risk factors for SARS-CoV-2 infection among employees of the UZ Brussel. | Change from baseline to 2 months and 5 months timepoint | 
| Proportion of asymptomatic seroconversions | - To quantify the proportion of asymptomatic seroconversions among employees of the UZ Brussel over a period of five months. | Change from baseline to 2 months and 5 months timepoint | 
| Concerns for safety for infection with COVID-19 | - To document the concerns of HCW and non-HCW about their safety for infection with COVID-19. | Change from baseline to 2 months and 5 months timepoint |