SARS-CoV-2CHARMINGNCT04779424
Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium (COVID-19)
An observational study of SARS-CoV-2 and COVID-19, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- POCT
- How many people
- 3,390 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2020to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read more
- how many PHCPs get infected or diseased in Belgium,
- the rate at which this happens,
- their clinical spectrum,
- their risk factors,
- the effectiveness of the measures to prevent this from happening and
- 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.
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- POCT
- Keywords
- Seroepidemiologic Studies, Primary Health Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCTOther
Capillary blood sample antibody point of care test
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: POCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 24/12/2020-08/01/2021
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)).
Measured: 25/01/2021-31/1/2021
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)).
Measured: 22-28/02/2021
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)).
Measured: 22-28/03/2021
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)).
Measured: 19-25/04/2021
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)).
Measured: 17-23/05/2021
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)).
Measured: 14-20/06/2021
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)).
Measured: 13-19/09/2021
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)).
Measured: 13-19/12/2021
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)).
Measured: 24/12/2020-19/12/2021
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)).
Measured: 24/12/2020-19/12/2021
Secondary outcomes (5)
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)).
Measured: 24/12/2020-19/12/2021
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.
Measured: 24/12/2020-19/12/2021
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.
Measured: 24/12/2020-19/12/2021
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'.
Measured: 25/01/2021-31/1/2021
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
Measured: 25/01/2021-31/1/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start15 Nov 2020
- Primary completion31 Dec 2021
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Sciensano, University of Liege
- Responsible party
- Principal investigator, Samuel Coenen, MD PhD, Universiteit Antwerpen
- Investigators
- Beatrice Scholtes, MD PhD, Principal investigator, University of LiegeElza Duysburgh, MD PhD, Principal investigator, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779424
- Sponsor's protocol ID
- OZ8478
- Acronym
- CHARMING
- Status last verified
- Nov 2023
- First submitted
- 22 Feb 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. Requests can be directed at both samuel.coenen@uantwerpen.be and elza.duysburgh@sciensano.be.
Publications
Domen J, Abrams S, Digregorio M, Van Ngoc P, Duysburgh E, Scholtes B, Coenen S. Predictors of moderate-to-severe side-effects following COVID-19 mRNA booster vaccination: a prospective cohort study among primary health care providers in Belgium. BMC Infect Dis. 2024 Oct 10;24(1):1135. doi: 10.1186/s12879-024-09969-8.
PubMed 39390398Domen J, Verbakel JYJ, Adriaenssens N, Scholtes B, Peeters B, Bruyndonckx R, De Sutter A, Heytens S, Van den Bruel A, Desombere I, Van Damme P, Goossens H, Buret L, Duysburgh E, Coenen S. Validation of a rapid SARS-CoV-2 antibody test in general practice. BMJ Open. 2023 May 2;13(5):e069997. doi: 10.1136/bmjopen-2022-069997.
PubMed 37130685Adriaenssens 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.
PubMed 36123069Adriaenssens 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.
PubMed 35105642
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04779424
- Acronym / sponsor ID
- CHARMING / OZ8478
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- Seroepidemiologic Studies, Primary Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,390 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Sciensano, University of Liege
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- how many PHCPs get infected or diseased in Belgium,
- the rate at which this happens,
- their clinical spectrum,
- their risk factors,
- the effectiveness of the measures to prevent this from happening and
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Health Care Providers (PHCPs) | – | Other: POCTAny 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCTCapillary blood sample antibody point of care test | Other | Primary Health Care Providers (PHCPs) |
Primary outcome
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)).
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)).
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)).
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)).
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)).
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)).
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)).
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)).
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)).
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)).
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)).
5 secondary outcomes
Longevity of antibodies against SARS-CoV-2 in primary health care providers
Time frame: 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
Determinants of of SARS-CoV-2 infection among primary health care providers
Time frame: 24/12/2020-19/12/2021
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 39390398Domen J, Abrams S, Digregorio M, Van Ngoc P, Duysburgh E, Scholtes B, Coenen S. Predictors of moderate-to-severe side-effects following COVID-19 mRNA booster vaccination: a prospective cohort study among primary health care providers in Belgium. BMC Infect Dis. 2024 Oct 10;24(1):1135. doi: 10.1186/s12879-024-09969-8.
- Derived from this study: PubMed 37130685Domen J, Verbakel JYJ, Adriaenssens N, Scholtes B, Peeters B, Bruyndonckx R, De Sutter A, Heytens S, Van den Bruel A, Desombere I, Van Damme P, Goossens H, Buret L, Duysburgh E, Coenen S. Validation of a rapid SARS-CoV-2 antibody test in general practice. BMJ Open. 2023 May 2;13(5):e069997. doi: 10.1136/bmjopen-2022-069997.
- Derived from this study: PubMed 36123069Adriaenssens 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.
- Derived from this study: PubMed 35105642Adriaenssens 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.
- link to study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Scholtes, MD PhD principal investigator
University of Liege
Elza Duysburgh, MD PhD principal investigator
Sciensano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T1 (time frame: 24/12/2020-08/01/2021). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779424, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.