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

NCT04779424 | Completed

• 1 other identifier: OZ8478
• Study Type: observational
• Target: 3,390
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SARS-CoV-2; COVID-19

Keywords

Seroepidemiologic Studies; Primary Health Care

Outcome Measures

Primary Outcomes (11)

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T1

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 1 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  24/12/2020-08/01/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T2

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 2 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  25/01/2021-31/1/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T3

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 3 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  22-28/02/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T4

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 4 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  22-28/03/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T5

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 5 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  19-25/04/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T6

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 6 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  17-23/05/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T7

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 7 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  14-20/06/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T8

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 8 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  13-19/09/2021

• Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T9

  The investigators will assess the prevalence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium at timepoint 9 using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  13-19/12/2021

• Monthly incidence of antibodies against SARS-CoV-2 in primary health care providers

  The investigators will assess the monthly incidence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium during a 12 month follow-up period using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  24/12/2020-19/12/2021

• Annual incidence of antibodies against SARS-CoV-2 in primary health care providers

  The investigators will assess the annual incidence of antibodies against SARS-CoV-2 in primary health care providers (PHCPs; general practitioners (GPs) and other PHCPs in their practice) in Belgium during a 12 month follow-up period using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

  24/12/2020-19/12/2021

Secondary Outcomes (5)

• Longevity of antibodies against SARS-CoV-2 in primary health care providers

  24/12/2020-19/12/2021

• Proportion of asymptomatic cases among primary health care providers with antibodies against SARS-CoV-2

  24/12/2020-19/12/2021

• Determinants of of SARS-CoV-2 infection among primary health care providers

  24/12/2020-19/12/2021

• Validation of a self-administered and self-reported serological point of care test in a primary care setting

  25/01/2021-31/1/2021

• Familiarisation with a self-administered and self-reported serological point of care test among primary health care providers

  25/01/2021-31/1/2021

Study Arms (1)

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).

Other: POCT

Interventions

POCT OTHER

Capillary blood sample antibody point of care test

Primary Health Care Providers (PHCPs)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Sciensano: collaborator
• University of Liege: collaborator

Study Sites (1)

Niels Adriaenssens

Wilrijk, Antwerp, 2610, Belgium

Location

Related Publications (4)

• 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.

  PMID: 39390398 DERIVED

• 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.

  PMID: 37130685 DERIVED

• 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.

  PMID: 36123069 DERIVED

• 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.

  PMID: 35105642 DERIVED

Related Links

• link to study protocol

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Capillary blood sample antibody point of care test 2. Serum blood sample

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Beatrice Scholtes, MD PhD

  University of Liege

  PRINCIPAL INVESTIGATOR

• Elza Duysburgh, MD PhD

  Sciensano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Clinical Epidemiology - Principal investigator

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 3, 2021
• Study Start: November 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: Data are available upon reasonable request. Requests can be directed at both samuel.coenen@uantwerpen.be and elza.duysburgh@sciensano.be.

Locations

BE (1)