Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium (COVID-19)

NCT ID: NCT04779424

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-15

Study Completion Date

2023-03-31

Brief Summary

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This protocol focuses on the seroprevalence in primary care health care providers (PHCPs) in Belgium.

PHCPs manage the vast majority of COVID-19 and other patients and therefore are essential to organize health care efficiently. Currently however, evidence is lacking on

1. how many PHCPs get infected or diseased in Belgium,
2. the rate at which this happens,
3. their clinical spectrum,
4. their risk factors,
5. the effectiveness of the measures to prevent this from happening and
6. the accuracy of the immunological serology-based point-of-care test in a primary care setting.

This study will be set up as a prospective cohort study. All Belgian GPs in clinical practice will be invited to register online for participation in this national epidemiological study and will be asked to invite the other PHCPs in their practice to do the same. A model and demography-informed sample of registered GPs and other PHCPs will be selected. These participants will be asked at each testing point to perform a capillary blood sample antibody point of care test (OrientGeneĀ®) and complete an online questionnaire. All data analysis will be performed and reported after each relevant testing period and at the end of the study.

Detailed Description

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Conditions

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SARS-CoV-2 COVID-19

Keywords

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Seroepidemiologic Studies Primary Health Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Health Care Providers (PHCPs)

Any Belgian general practitioner (GP) (including those in professional training) currently working in primary care and any other primary health care providers (PHCPs) from the same GP practice who physically manage (examine, test, treat) patients/clients (frontline PHCP).

POCT

Intervention Type OTHER

Capillary blood sample antibody point of care test

Interventions

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POCT

Capillary blood sample antibody point of care test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any Belgian general practitioner (GP) (including those in professional training) currently working in primary care and any other primary health care providers (PHCPs) from the same GP practice who physically manage (examine, test, treat) patients/clients (frontline PHCP), are able to comply with the study protocol and provided informed consent to participate in the study. Also PHCPs having been diagnosed with COVID-19 are included.

Exclusion Criteria

* Staff hired on a temporary (interim) basis will be excluded as follow-up over time will be compromised.
* Administrative staff or technical staff without any contact with patients/clients will also be excluded.
* PHCPs who were not active during the inclusion period will automatically be excluded.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sciensano

OTHER_GOV

Sponsor Role collaborator

University of Liege

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Samuel Coenen, MD PhD

Professor Clinical Epidemiology - Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beatrice Scholtes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege

Elza Duysburgh, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sciensano

Locations

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Niels Adriaenssens

Wilrijk, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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Domen J, Abrams S, Digregorio M, Van Ngoc P, Duysburgh E, Scholtes B, Coenen S. Predictors of moderate-to-severe side-effects following COVID-19 mRNA booster vaccination: a prospective cohort study among primary health care providers in Belgium. BMC Infect Dis. 2024 Oct 10;24(1):1135. doi: 10.1186/s12879-024-09969-8.

Reference Type DERIVED
PMID: 39390398 (View on PubMed)

Domen J, Verbakel JYJ, Adriaenssens N, Scholtes B, Peeters B, Bruyndonckx R, De Sutter A, Heytens S, Van den Bruel A, Desombere I, Van Damme P, Goossens H, Buret L, Duysburgh E, Coenen S. Validation of a rapid SARS-CoV-2 antibody test in general practice. BMJ Open. 2023 May 2;13(5):e069997. doi: 10.1136/bmjopen-2022-069997.

Reference Type DERIVED
PMID: 37130685 (View on PubMed)

Adriaenssens N, Scholtes B, Bruyndonckx R, Van Ngoc P, Verbakel JYJ, De Sutter A, Heytens S, Van Den Bruel A, Desombere I, Van Damme P, Goossens H, Buret L, Duysburgh E, Coenen S. Prevalence, incidence and longevity of antibodies against SARS-CoV-2 among primary healthcare providers in Belgium: a prospective cohort study with 12 months of follow-up. BMJ Open. 2022 Sep 19;12(9):e065897. doi: 10.1136/bmjopen-2022-065897.

Reference Type DERIVED
PMID: 36123069 (View on PubMed)

Adriaenssens N, Scholtes B, Bruyndonckx R, Verbakel JY, De Sutter A, Heytens S, Van den Bruel A, Desombere I, Van Damme P, Goossens H, Buret L, Duysburgh E, Coenen S. Prevalence and incidence of antibodies against SARS-CoV-2 among primary healthcare providers in Belgium during 1 year of the COVID-19 epidemic: prospective cohort study protocol. BMJ Open. 2022 Jan 31;12(1):e054688. doi: 10.1136/bmjopen-2021-054688.

Reference Type DERIVED
PMID: 35105642 (View on PubMed)

Related Links

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Other Identifiers

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OZ8478

Identifier Type: -

Identifier Source: org_study_id