NCT04426292

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

November 4, 2021

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

June 8, 2020

Last Update Submit

November 3, 2021

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Incidence of definite cases

    Change from baseline to 2 months and 5 months timepoint

  • Incidence of probable cases

    Change from baseline to 2 months and 5 months timepoint

  • Antibody kinetics

    Change from baseline to 2 months and 5 months timepoint

  • Potential work-related risk factors

    Change from baseline to 2 months and 5 months timepoint

  • Proportion of asymptomatic seroconversions

    Change from baseline to 2 months and 5 months timepoint

  • +1 more secondary outcomes

Study Arms (1)

General arm

OTHER

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

Interventions

Serological testingDIAGNOSTIC_TEST

Antibody testing for Sars-COV-2 antibodies in blood.

General arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any adult employee of the UZ Brussel who provided a signed informed consent to participate in the study.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Interventions

COVID-19 Serological Testing

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSerologic TestsImmunologic TestsInvestigative TechniquesImmunologic Techniques

Central Study Contacts

Sabine Allard, MD

CONTACT

1923369sabine.allard@uzbrussel.be

Laurien De Greef, Nurse

CONTACT

1929849laurien.degreef@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

May 12, 2020

Primary Completion

December 23, 2021

Study Completion

December 25, 2021

Last Updated

November 4, 2021

Record last verified: 2021-06

Locations

BE(1)