COVID-19 in Vitro Diagnostic Near-patient Testing in Care Environments Using a Cluster Randomised Open-label Trial Design in an East London Care Home Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 461
- 试验地点
- 2
- 主要终点
- CoV-2 Infection after 21 days
研究概览
简要总结
The primary objective of the study is to determine whether, at 21 days, care homes that implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than care homes following the DHSC standard of care testing of symptomatic residents.
详细描述
Accurate, rapid, near-patient testing systems, such as q16+CoV-2, allow for daily routine testing of residents, and of staff and visitors prior to entering the care home.
Daily CoV-2 PCR testing with high analytical sensitivity (e.g., 2 copies per 8 µl sample) may detect infected residents and visitors before clinical symptoms are apparent. Earlier detection may lead to earlier implementation of the UK standard of care protocol for Infection prevention and control measures, thereby preventing the asymptomatic infected individuals from introducing and/or transmitting CoV-2 within the care home. This should reduce the transmission by:
Preventing the introduction of the virus into care homes from external visitors e.g., GPs (Inward transmission) Preventing the spread of the virus within care homes and preventing cluster development (internal transmission) Preventing the outward spread of the virus from within care homes by infection of external visitors (Outward transmission)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking will be used as the study arms have different testing patterns
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons resident or requiring access to the care home
- •Capable of giving written informed consent, or if appropriate, having an acceptable individual capable of giving consent on the participant's behalf.
排除标准
- •Persons not providing informed consent or withdrawing consent at any time during the study.
- •Persons requiring urgent and immediate access to the care home, for example medical staff attending emergency visits.
- •Persons unable to provide nasal or oropharyngeal swabs for medical reasons.
结局指标
主要结局
CoV-2 Infection after 21 days
时间窗: 21 days
The cumulative number of confirmed cases of CoV-2 infection after 21 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors
次要结局
- CoV-2 Infection after 14 days(14 days)
- Cases of suspected or confirmed CoV-2 infection(14 days)
- Hospitalisation and death(21 days and 40 days)