Mobile PCR-based Surveillance for SARS-CoV-2 to Reduce Visiting Restrictions in Nursing Homes During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,587
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 infection among residents
研究概览
简要总结
Residents in nursing homes for the senior citizens (NH) are at high risk for death from COVID-19. We investigated whether repeated non-mandatory RT-PCR SARS-CoV-2 surveillance of NH staff and visitors reduces COVID-19 incidence rates in NH residents and allows to reduce visiting restrictions.
详细描述
Nursing homes for senior citizens are considered risk areas for the transmission of SARS-CoV-2. To protect these risk groups, different strategies have been implemented within the framework of legally applicable conditions. The aim of this study is to observe two procedural standards (e.g. visiting restrictions, hygiene measurements):
- On the one hand, a standard procedure without testing of visitors and employees and
- on the other hand, a standard procedure with additional surveillance by voluntary testing of visitors and staff for SARS-CoV-2 and associated relaxation of measures for contact of visitors with residents.
Both standard procedures are designed to ensure adequate protection against infection. The standard procedure with the use of relaxing the measures after testing aims to make the experience of social isolation more bearable for the residents of care facilities and thus less stressful from a psychological point of view. The extent of such possible effects is not the subject of the present study.
The primary aim of the study is to observe the number of SARS-CoV-2 infections among residents of nursing homes for senior citizens under different procedural standards for infection control.
In this study, various measures specified by care institutions for visits to senior citizens' homes are accompanied by scientific screening. The aim of the screening and the analysis of infection protection measures is to enable this vulnerable group to regain participation in society but still slow down the spread of the virus and prevent an outbreak.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One-time or frequent visitors in care facilities of the INH group who want to be tested for SARS-CoV-2 voluntarily
- •employees (HCW) in care facilities of the INH group who want to be tested voluntarily
- •Successful declaration of consent via the UKK Corona web tool
排除标准
- •Visitors and employees in care facilities of the INH group with signs of SARS-CoV-2 infection
- •No participants in the context of the study are in principle:
- •one-time and frequent visitors in care facilities of the CNH group
- •employees in care facilities of the CNH group
- •Residents in care facilities of the CNH and the INH group
结局指标
主要结局
SARS-CoV-2 infection among residents
时间窗: Oct 15th until Dec 18th, 2020
SARS-CoV-2 infection among residents in INH and CNH (proof of SARS-CoV-2 DNA on nasopharyngeal swab with or without symptoms of SARS-CoV-2 infection)
次要结局
- SARS-CoV-2 infection among visitors and health-care workers (HCW) of INH(Oct 15th until Dec 18th, 2020)
- Comparison of sensitivity of SARS-CoV-2 rtPCR and SARS-CoV-2 rapid antigen tests(Oct 15th until Dec 18th, 2020)
- Overall mortality, COVID-19 related mortality, and excess mortality(up to two weeks after study completion)
研究者
Oliver Cornely, MD
Professor, Doctor
University of Cologne