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Completed

NCT Number: NCT04779424

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

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.

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Key information

Conditions

SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Niels Adriaenssens

Wilrijk, Antwerp, 2610, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

POCT

Other

Capillary blood sample antibody point of care test

Primary outcomes

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

    Time frame: 24/12/2020-08/01/2021

    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)).

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

    Time frame: 25/01/2021-31/1/2021

    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)).

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

    Time frame: 22-28/02/2021

    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)).

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

    Time frame: 22-28/03/2021

    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)).

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

    Time frame: 19-25/04/2021

    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)).

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

    Time frame: 17-23/05/2021

    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)).

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

    Time frame: 14-20/06/2021

    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)).

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

    Time frame: 13-19/09/2021

    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)).

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

    Time frame: 13-19/12/2021

    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)).

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

    Time frame: 24/12/2020-19/12/2021

    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)).

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

    Time frame: 24/12/2020-19/12/2021

    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)).

Secondary outcomes

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

    Time frame: 24/12/2020-19/12/2021

    The investigators will assess the duration of the SARS-CoV-2 antibody response among seropositive PHCPs using a self-administered and self-reported serological point of care test based on a capillary blood sample (OrientGene(r)).

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

    Time frame: 24/12/2020-19/12/2021

    The investigators will assess the proportion of asymptomatic cases among (new) cases (that develop during follow-up) of primary health care providers (PHCPs) with antibodies against SARS-CoV-2 based on information collected using an online questionnaire.

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

    Time frame: 24/12/2020-19/12/2021

    The investigators will assess the determinants of SARS-CoV-2 infection in primary health care providers (PHCPs), including PHCPs characteristics, availability and use of personal protective equipment, and exposure to COVID-19 patients, based on information collected using an online questionnaire.

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

    Time frame: 25/01/2021-31/1/2021

    The investigators will validate the immunological serology-based POCT in a primary care setting (Phase 3 validation) by assessing the sensitivity and specificity of a self-administered and self-reported serological point of care test based on capillary blood sample (OrientGene(r)) against a reference standard (laboratory serological test based on serum blood sample). As reference standard the following testing algorithm will be use, i.e. serum samples will be tested first on the ELECSYS Anti-SARS-CoV-2 S assay (Roche, Basel, Switzerland), if the cut-off index (COI) is between 0.85-3.29 the sample will be tested on the ATELLICA IM SARS-CoV-2 assay (Siemens, Munich, Germany), and if discordant results it will be tested on the LIAISON SARS-CoV-2 S1/S2 IgG assay (DiaSorin, Saluggia, Italy), using a two out of three 'reference standard'.

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

    Time frame: 25/01/2021-31/1/2021

    The investigators will assess the success rate and user-friendliness of a self-administered and self-reported serological point of care test (OrientGene(r)) based on information collected using an online questionnaire

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Sciensano
  • University of Liege

Registry information

Official study title

Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium During One Year of the COVID-19 Epidemic

Acronym: CHARMING

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Mar 3, 2021
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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