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

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.

Study Overview

• Status: Recruiting
• Conditions: Sars-CoV2
• Intervention / Treatment: Diagnostic test: Serological testing

• Study Type: Interventional
• Enrollment (Anticipated): 3500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabine Allard, MD; Phone Number: 1923369; Email: sabine.allard@uzbrussel.be
• Study Contact Backup: Name: Laurien De Greef, Nurse; Phone Number: 1929849; Email: laurien.degreef@uzbrussel.be

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • UZ Brussel
      • Contact: Laurien De Greef, Nurse; Phone Number: 1929849; Email: laurien.degreef@uzbrussel.be
      • Principal Investigator: Sabine Allard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: General arm; 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; Antibody testing for Sars-COV-2 antibodies in blood.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Anticipated): December 23, 2021
• Study Completion (Anticipated): December 25, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: COVEMUZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No