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

Sars-CoV2 Clinical Trial

— COVEMUZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04426292
• Other study ID #: COVEMUZ
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: December 25, 2021

Study information

• Verified date: June 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: Sabine Allard, MD
• Phone: 1923369
• Email: sabine.allard[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 25, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV2

Intervention

Diagnostic Test:
• Serological testing
Antibody testing for Sars-COV-2 antibodies in blood.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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