Prevalence and Incidence of Antibodies Against SARS-CoV-2 Among Primary Healthcare Providers in Belgium During One Year of the COVID-19 Epidemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,390
- 试验地点
- 1
- 主要终点
- Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T4
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T4
时间窗: 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 - T6
时间窗: 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 - T9
时间窗: 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)).
Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T3
时间窗: 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 - T8
时间窗: 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 - T5
时间窗: 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 - T7
时间窗: 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)).
Monthly incidence of antibodies against SARS-CoV-2 in primary health care providers
时间窗: 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)).
Prevalence of antibodies against SARS-CoV-2 in primary health care providers - T1
时间窗: 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
时间窗: 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)).
Annual incidence of antibodies against SARS-CoV-2 in primary health care providers
时间窗: 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)).
次要结局
- Proportion of asymptomatic cases among primary health care providers with antibodies against SARS-CoV-2(24/12/2020-19/12/2021)
- Validation of a self-administered and self-reported serological point of care test in a primary care setting(25/01/2021-31/1/2021)
- Longevity of antibodies against SARS-CoV-2 in primary health care providers(24/12/2020-19/12/2021)
- Familiarisation with a self-administered and self-reported serological point of care test among primary health care providers(25/01/2021-31/1/2021)
- Determinants of of SARS-CoV-2 infection among primary health care providers(24/12/2020-19/12/2021)
研究者
Samuel Coenen, MD PhD
Professor Clinical Epidemiology - Principal investigator
Universiteit Antwerpen