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Clinical Trials/NCT04426292
NCT04426292UnknownNot Applicable

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

Universitair Ziekenhuis Brussel2 sites in 1 country3,500 target enrollmentStarted: May 12, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
3,500
Locations
2
Primary Endpoint
Seroprevalence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Seroprevalence

Time Frame: 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.

seroconversions

Time Frame: 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 Outcomes

  • Incidence of probable cases(Change from baseline to 2 months and 5 months timepoint)
  • Incidence of definite cases(Change from baseline to 2 months and 5 months timepoint)
  • Antibody kinetics(Change from baseline to 2 months and 5 months timepoint)
  • Proportion of asymptomatic seroconversions(Change from baseline to 2 months and 5 months timepoint)
  • Concerns for safety for infection with COVID-19(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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