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

COVID-19 Clinical Trial

— CHARMING  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779424
• Other study ID #: OZ8478
• Status: Completed
• Start date: November 15, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2023
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3390
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Other:
• POCT
Capillary blood sample antibody point of care test

Locations

Country	Name	City	State
Belgium	Niels Adriaenssens	Wilrijk	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Sciensano, University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Longevity of antibodies against SARS-CoV-2 in primary health care providers	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
Secondary	Proportion of asymptomatic cases among primary health care providers with antibodies against SARS-CoV-2	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
Secondary	Determinants of of SARS-CoV-2 infection among primary health care providers	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
Secondary	Validation of a self-administered and self-reported serological point of care test in a primary care setting	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
Secondary	Familiarisation with a self-administered and self-reported serological point of care test among primary health care providers	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

External Links

•   link to study protocol