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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04779424
Recruitment Status : Active, not recruiting
First Posted : March 3, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborators:
Sciensano
University of Liege
Information provided by (Responsible Party):
Samuel Coenen, MD PhD, Universiteit Antwerpen

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.


Condition or disease Intervention/treatment
SARS-CoV-2 COVID-19 Other: POCT

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Capillary blood sample antibody point of care test




Primary Outcome Measures :
  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 Outcome Measures :
  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-administerted 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


Biospecimen Retention:   Samples Without DNA
  1. Capillary blood sample antibody point of care test
  2. Serum blood sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779424


Locations
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Belgium
Niels Adriaenssens
Wilrijk, Antwerp, Belgium, 2610
Sponsors and Collaborators
Universiteit Antwerpen
Sciensano
University of Liege
Investigators
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Principal Investigator: Beatrice Scholtes, MD PhD University of Liege
Principal Investigator: Elza Duysburgh, MD PhD Sciensano
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samuel Coenen, MD PhD, Professor Clinical Epidemiology - Principal investigator, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT04779424    
Other Study ID Numbers: OZ8478
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available upon reasonable request. Requests can be directed at both samuel.coenen@uantwerpen.be and elza.duysburgh@sciensano.be.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Access Criteria: Data are available upon reasonable request. Requests can be directed at both samuel.coenen@uantwerpen.be and elza.duysburgh@sciensano.be.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Coenen, MD PhD, Universiteit Antwerpen:
Seroepidemiologic Studies
Primary Health Care
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases