COVID-19 Prevalence in UNIVI Group Nursing Homes and Geriatric Healthcare Institutions: Epidemiological Study of Immunological Status With Rapid Serological Tests for Diagnostic Guidance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,145
- 试验地点
- 1
- 主要终点
- Among asymptomatic residents and caregivers in French nursing homes and geriatric healthcare institutions belonging to the UNIVI Group: prevalence of covid 19
研究概览
简要总结
To date, little information is available on the prevalence of Covid-19 and data are lacking on the proportion of patients, institutional residents and caregivers who have actually been exposed to SARS Cov-2.
With the NG Biotech rapid serological test, an individual's immunological status (presence of IgM and IgG antibodies) can be determined in 15 minutes on a finger-prick blood sample.
The proposed trial will be a noninterventional study of immunological status among the residents and caregivers of 26 nursing homes and 4 geriatric healthcare institutions belonging to the UNIVI Group who are representative of the institutional geriatric population in France. The NG Biotech rapid test will be carried out concomitantly with polymerase chain reaction (PCR) tests performed within the framework of a national screening campaign. Data on risk factors in staff members and on specific COVID 19 symptoms in residents will also be collected.
The study will terminate for residents and caregivers whose tests are both negative (absence of infection and no exposure to the virus). For residents and caregivers who have at least one positive test, follow-up visits will be scheduled in order to study the serology time course and the occurrence of reinfection (follow-up questionnaire).
详细描述
Type of study: multicentric prospective observational Study location: 26 nursing homes and 4 geriatric hospitals belonging to the UNIVI Group in France
Context:
At the end of the Covid-19 containment period in France, data published by Public Health France revealed that frail and dependent elderly people in nursing homes and geriatric healthcare institutions had paid a heavy tribute. As of May 4, 2020, the majority of reported Covid-19 cases (n=4,600; 63%) had occurred in nursing home residents and more than one-third (n=2,664; 37%) in patients in geriatric healthcare institutions. A total of 71,216 Covid-19 cases of which 33,948 (48%) were confirmed by reverse transferase polymerase chain reaction (RT-PCR) tests were reported to health authorities (Agence Régionale de Santé, ARS). Among reported cases, there were 12,726 deaths. Three-quarters of these deaths (9,501; 75%) occurred in geriatric institutions, the vast majority (99%) in nursing homes and 3,321 (25%) in hospitals. Reports of infection among staff members of these institutions reached 39,294 cases, of which 18,175 (46%) were confirmed by RT- PCR.
The confinement allowed a significant and continuous decrease in the number of Covid cases in French geriatric institutions since the beginning of April. The proportion of new cases observed among institutionalized geriatric residents has since fallen sharply, particularly in the most affected geographic regions. This is why deconfinement should be gradual and should be constantly reassessed on the basis of national and regional epidemiological data. Each nursing home should to take into account its own daily data showing the number of new diagnoses or suspected cases among residents and caregivers, keeping in mind the risk of transmission by visitors in the event of a recurrence of the epidemic.
In France, the deconfinement strategy began on April 20, 2020 in Île-de-France. Family visits under strict conditions were authorized in geriatric institutions. Currently, the modus operandi is accompanied by a PCR test campaign in order to have an inventory of the COVID status of all institutional residents and caregivers. Thus, any resident with a positive PCR test will be isolated until recovery and any caregiver with a positive PCR test will be quarantined.
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
- 是
入选标准
- •Residents of participating nursing home - who benefited from a rapid diagnostic orientation serological test for COVID-19 - having given their agreement
- •All staff members (doctors, nurses, health executives, caregivers, physiotherapists, ASH, stretcher bearers, psychologists, dieteticians, administrative staff, secretaries, ...) - who benefited from a rapid diagnostic orientation serologic test for COVID-19 - having given their agreement
排除标准
- •Refusal to participate
结局指标
主要结局
Among asymptomatic residents and caregivers in French nursing homes and geriatric healthcare institutions belonging to the UNIVI Group: prevalence of covid 19
时间窗: three months
positive RT-PCR test and/or (for residents) clinical diagnosis recorded in the medical file
Exposure to SARS Cov-2 Among asymptomatic residents and caregivers in French nursing homes and geriatric healthcare institutions belonging to the UNIVI Group
时间窗: three months
positive NG Biotech rapid serological test
次要结局
- Recurrence of Covid-19 at 1, 3 and 6 months among residents and caregivers who had at least on positive test at inclusion (RT-PCR test or NB Biotech rapid serological test)(Time Frame: one, three and six months after inclusion])
- Covid-19 symptoms among residents(three months)
- Prevalence of Covid-19 at 3 months(three months)
- Risk factors for Covid-19 infection in caregivers(three months)