Household Transmission Dynamics and Viral Load Among Asymptomatic SARS-CoV-2 Infected Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 5
- 主要终点
- Symptoms of COVID-19 in household members of participating children in the subsequent 14 days following enrollment
研究概览
简要总结
The primary objective of this study is quantify the transmission risk posted by SARS-CoV-2 in pre/asymptomatic infected children in order to inform the public health response to the COVID-19 pandemic.
详细描述
- Background & Rationale:
Background: Transmission from individuals with pre-symptomatic and asymptomatic (hereafter abbreviated as pre/asymptomatic) SARS-CoV-2 infections is the Achilles' heel of COVID-19 pandemic control1. While pediatric SARS-CoV-2 infection is yet to be fully characterized, and generally children are more likely to experience asymptomatic infection or mild disease compared with adults, severe outcomes are possible. Although person-to-person spread is well described in children, as schools have been closed, the transmission risk in that environment remains unknown. More importantly, the contribution of pre/asymptomatic children to overall transmission of SARS-CoV-2 is unclear with most pediatric cases linked to a symptomatic household member. According to China's National Health Commission, 130 (78%) of 166 new infections identified on April 1, 2020 were asymptomatic. In addition, data from an adult long-term care facility in Washington indicates that symptom-based screening failed to identify a significant proportion of COVID-19 cases. Furthermore, based on RT-PCR cycle threshold values, large quantities of viral RNA were detected in pre/asymptomatic residents, suggesting the potential for transmission regardless of symptoms. Asymptomatic pediatric colonization, while reported, is poorly described.
Rationale: SARS-CoV-2 shedding has been noted to occur in minimally symptomatic and asymptomatic infected persons. Children therefore, who appear to more commonly experience mild and asymptomatic infection, may represent a significant risk of household and community transmission. Recommendations for school closures are currently based on assumptions as well as evidence gathered from influenza outbreaks where these measures are known to reduce social contacts and interrupt transmission. School closures, however, disrupt the lives of students and their families and may have negative consequences on child health16. Moreover, COVID-19 transmission modelling studies predict that school closures alone prevent only 2 - 4% of COVID-19-related deaths in the general population, much less than other physical distancing interventions. It should be noted that as school closures were in place before observational studies could begin, the secondary clinical attack rate of pre/asymptomatic children is unknown. 2. Research Questions & Objectives:
The primary objective of this study is quantify the transmission risk posted by SARS-CoV-2 in pre/asymptomatic infected children in order to inform the public health response to the COVID-19 pandemic by determining the following:
If the proportion of household members who develop symptomatic illness over the subsequent 12 days is greater among households of pre/asymptomatic SARS-CoV-2 positive children relative to negative children. Mathematical models will be developed to understand the risks associated with other community transmission settings.
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
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Younger than 18 years of age
- •Had SARS-CoV-2 NAT testing performed during the ED visit as part of an ongoing active asymptomatic surveillance program:
- •Exposed (SARS-CoV-2 positive) specific: Was found positive by SARS-CoV-2 NAT testing in the ongoing active surveillance program
- •Unexposed (SARS-CoV-2 negative/control) specific: Was found negative by SARS-CoV-2 NAT testing in the ongoing active surveillance program
排除标准
- •Presence of any of the following viral symptoms commonly associated with SARS-CoV- 2 infection: fever, cough, dyspnea/difficulty breathing, generalized fatigue/weakness, myalgia (muscle or body aches), chills, feeling very unwell, sore throat, runny nose, gastrointestinal symptoms (vomiting, diarrhea), conjunctivitis, headache, anosmia (loss of smell), ageusia (loss of taste) or rash in the 24 hours preceding the index visit (when the child was tested for the presence of SARS-CoV-2).
- •Previously diagnosed with SARS-CoV-2 infection based on a positive swab or serology (blood) test.
- •Decline to provide informed consent and/or assent, as required
结局指标
主要结局
Symptoms of COVID-19 in household members of participating children in the subsequent 14 days following enrollment
时间窗: 14 days
The clinical secondary attack rate (SAR) for households of participating children, which will be compared to generate the relative SAR for households of children with varying case and symptom statuses.
次要结局
- Viral Load of SARS-CoV-2 in positive children(14 days)
