SARS-CoV-2 Seroprevalence Among Nursing Home Staff and Residents in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sciensano
- 入组人数
- 3,008
- 试验地点
- 1
- 主要终点
- Change of seroprevalence of anti-SARS-CoV-2 antibodies among nursing home residents and staff in Belgium
研究概览
简要总结
Assessment of the seroprevalence and sero-incidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) among Nursing Home (NH) residents and staff in Belgium.
详细描述
In this longitudinal cohort study, 3036, nursing home (NH) residents (1656) and staff (1380), spread over 69 nursing homes throughout Belgium will be repeatedly sampled at a 2-month interval. Seroprevalence and -incidence will be assessed by means of a point-of-care rapid antibody test with additional collection of a Dry Blood Spot sample for quantitative detection of immune markers*. Sample collection (capillary blood samples) at baseline (day 0, week 0) will start in a staggered way, so all baseline samples among the different nursing homes are collected within the first 21 days after collection of the first sample. Follow-up sample collection will occur with a 2-month interval in week 8, week 16, week 24, week 32 and week 40 after the baseline collection of that specific nursing home. At each timepoint, questionnaires will be taken concerning medical history, clinical outcomes and potential COVID-19 riskfactors. The recruited NHs will be equally spread across the Belgian territory according to geographic and demographic characteristics to guarantee general representativity. Forty-four participants (20 staff, 24 residents) will be randomly included per nursing home. (* collection of the Dry Blood Spot is part of a sub-study by Ghent University)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •residents and staff from Belgian nursing homes
排除标准
- •service flat residents
- •temporary staff, employed for a period of less then 1 year starting from baseline collection
结局指标
主要结局
Change of seroprevalence of anti-SARS-CoV-2 antibodies among nursing home residents and staff in Belgium
时间窗: "Month 0", "Month 2", "Month 4", "Month 6", "Month 8", "Month 10", "Month 13", "Month 16", "Month 19", "Month 22"
Change of seroprevalence of anti-SARS-CoV-2 antibodies among Belgian nursing home residents and staff detected in their capillary blood by a point of care test during a period of 10 months.
Change in SARS-CoV-2 seroconversion among nursing home residents and staff in Belgium
时间窗: "Month 0", "Month 2", "Month 4", "Month 6", "Month 8", "Month 10", "Month 13", "Month 16", "Month 19", "Month 22"
Change in SARS-CoV-2 seroconversion among Belgian nursing home residents and staff conducted by detecting specific SARS-CoV-2 IgG/IgM in their capillary blood by a point of care test at each of the study follow-up testing points.
次要结局
- Assess the risk of getting symptomatically SARS-CoV-2 infected between the seropositive and seronegative group at baseline(10 months)
- Assess the proportion of deaths within 10 months between sero-positive and -negative participants at baseline visit for NH residents.(10 months)
- Assess the seroconversion time in the group of sero-negative participants at baseline visit in relation to observed risk factors such as care dependency scale (for NH residents),type of job assignment and flu vaccination (for staff)(10 months)
- Assess the duration of SARS-CoV-2 antigen specific seropositivity among NH residents and staff in Belgium.(10 months)
- Assess the time until death within 10 months between sero-positive and -negative participants at baseline visit for NH residents(10 months)