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

November 28, 2023 updated by: Samuel Coenen, MD PhD, Universiteit Antwerpen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • Niels Adriaenssens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)).
24/12/2020-08/01/2021
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)).
25/01/2021-31/1/2021
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)).
22-28/02/2021
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)).
22-28/03/2021
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)).
19-25/04/2021
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)).
17-23/05/2021
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)).
14-20/06/2021
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)).
13-19/09/2021
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)).
13-19/12/2021
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)).
24/12/2020-19/12/2021
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)).
24/12/2020-19/12/2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)).
24/12/2020-19/12/2021
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.
24/12/2020-19/12/2021
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.
24/12/2020-19/12/2021
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
25/01/2021-31/1/2021
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'.
25/01/2021-31/1/2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiteit Antwerpen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Liege
Sciensano

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beatrice Scholtes, MD PhD, University of Liege
  • Principal Investigator: Elza Duysburgh, MD PhD, Sciensano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OZ8478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available upon reasonable request. Requests can be directed at both samuel.coenen@uantwerpen.be and elza.duysburgh@sciensano.be.

IPD Sharing Access Criteria

Data are available upon reasonable request. Requests can be directed at both samuel.coenen@uantwerpen.be and elza.duysburgh@sciensano.be.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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