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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT04426292
Collaborator
(none)
3,500
1
1
19.4
180

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serological testing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak
Actual Study Start Date :
May 12, 2020
Anticipated Primary Completion Date :
Dec 23, 2021
Anticipated Study Completion Date :
Dec 25, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Seroprevalence [Change from baseline to 2 months and 5 months timepoint]

    - 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.

  2. seroconversions [Change from baseline to 2 months and 5 months timepoint]

    - To document number of SARS-CoV-2 seroconversions among employees of the UZ Brussel over a period of 5 months.

Secondary Outcome Measures

  1. Incidence of definite cases [Change from baseline to 2 months and 5 months timepoint]

    - 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.

  2. Incidence of probable cases [Change from baseline to 2 months and 5 months timepoint]

    - 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.

  3. Antibody kinetics [Change from baseline to 2 months and 5 months timepoint]

    - 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.

  4. Potential work-related risk factors [Change from baseline to 2 months and 5 months timepoint]

    - To investigate potential work-related risk factors for SARS-CoV-2 infection among employees of the UZ Brussel.

  5. Proportion of asymptomatic seroconversions [Change from baseline to 2 months and 5 months timepoint]

    - To quantify the proportion of asymptomatic seroconversions among employees of the UZ Brussel over a period of five months.

  6. Concerns for safety for infection with COVID-19 [Change from baseline to 2 months and 5 months timepoint]

    - To document the concerns of HCW and non-HCW about their safety for infection with COVID-19.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Brussel Jette Brussel Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT04426292
Other Study ID Numbers:
  • COVEMUZ
First Posted:
Jun 11, 2020
Last Update Posted:
Nov 4, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 4, 2021