Clinical trial NCT04779424: Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium (COVID-19)
Official title: Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium During One Year of the COVID-19 Epidemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
COVID-19
Keywords: Seroepidemiologic Studies
Primary Health Care
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Sciensano
name: University of Liege
First posted: 2021-03-03
Enrollment: 3390
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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. 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 (OrientGene®) 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T1
timeFrame: 24/12/2020-08/01/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T2
timeFrame: 25/01/2021-31/1/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T3
timeFrame: 22-28/02/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T4
timeFrame: 22-28/03/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T5
timeFrame: 19-25/04/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T6
timeFrame: 17-23/05/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T7
timeFrame: 14-20/06/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T8
timeFrame: 13-19/09/2021
measure: Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T9
timeFrame: 13-19/12/2021
measure: Monthly incidence of antibodies against SARS-CoV-2 in primary health care providers
timeFrame: 24/12/2020-19/12/2021
measure: Annual incidence of antibodies against SARS-CoV-2 in primary health care providers
timeFrame: 24/12/2020-19/12/2021
Secondary outcomes:
measure: Longevity of antibodies against SARS-CoV-2 in primary health care providers
timeFrame: 24/12/2020-19/12/2021
measure: Proportion of asymptomatic cases among primary health care providers with antibodies against SARS-CoV-2
timeFrame: 24/12/2020-19/12/2021
measure: Determinants of of SARS-CoV-2 infection among primary health care providers
timeFrame: 24/12/2020-19/12/2021
measure: Validation of a self-administered and self-reported serological point of care test in a primary care setting
timeFrame: 25/01/2021-31/1/2021
measure: Familiarisation with a self-administered and self-reported serological point of care test among primary health care providers
timeFrame: 25/01/2021-31/1/2021
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Niels Adriaenssens
state: Antwerp
Study officials:
affiliation: University of Liege
name: Beatrice Scholtes, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sciensano
name: Elza Duysburgh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.