Core C Cohort Administration and Biospecimen Core

项目摘要 此请求是对NOT-AI-20-031补充资金的响应，以响应CoVID- 19日发生紧急情况。由SARS-CoV-2引起的传染病新冠肺炎正在迅速蔓延 全球各地的人类。虽然最初的流行病学数据主要集中在 导致严重的呼吸道疾病，主要见于成年人，很少有关于 儿童的感染负担是可以得到的。观察到，许多人认为 经病毒学确诊的儿童病例无症状。无证可查，而且很可能 传染性的病例可能导致接触社区的比例远远高于 否则就会发生。事实上，有人提出，未记录在案的(或沉默的)感染 是近80%有记录的感染的源头；因此，确定沉默的 儿童症状性感染率。克服临床研究的挑战 由目前的医疗保健准入限制强加的实施，一项在 Design将登记符合条件的儿童及其家庭成员，并对其进行前瞻性观察 目前参与了由美国国立卫生研究院资助的、正在进行的出生队列研究。这些孩子和他们的 研究人员知道家庭，作为他们参与HFHS研究的一部分，他们有 已经接触过监控研究中涉及的程序。我们要求 支持与我们的微生物区系和过敏性哮喘精确度保持一致的儿科研究 预防(MAAP2)(PI：Johnson，Ownby P01AI089473)参与多中心 题为“人类流行病学和应对SARS-CoV-2”的调查(HEROS)，第#号议定书 代特-新冠肺炎-001号。我们的主要目标是报告SARS-CoV-2感染的发病率 (检测鼻分泌物中的病毒)在队列儿童(指标儿童)和家庭中随时间推移 联系人(照顾者和兄弟姐妹)。第二个目标是比较SARS-CoV-2感染情况 特应性疾病(如哮喘， 湿疹)与没有特应性症状的儿童进行比较。作为一个探索性的目标，我们将调查 SARS-CoV-2感染(通过在鼻腔分泌物中检测到病毒来确定)是否 与粪便中病毒的存在有关。我们的目标招生对象是300个家庭 在2周的时间内，并跟踪了至少6个月。以预定的间隔， 生物样本(鼻拭子、外周血、粪便)将由护理员在 家庭使用提供给家庭的材料。将完成症状和暴露情况调查 在采集生物样本时，通过智能手机、在线或电话进行远程检查。 这一及时的多地点研究可以快速实施并实际进行，而无需 有必要访问临床研究中心，并将提供宝贵的信息 儿童感染SARS-CoV-2的负担。

Project Summary This request is in response to NOT-AI-20-031 for supplement funding in response to the CoVID- 19 emergency. COVID-19, the infectious disease caused by SARS-CoV-2, is rapidly affecting humans around the globe. While initial epidemiological data have focused on cases that resulted in severe respiratory disease seen predominantly in adults, little information regarding the infection burden in children is available. This is complicated by the observation that many virologically-confirmed cases in children are asymptomatic. Undocumented, and likely infectious, cases could result in exposure to a far greater proportion of the community than would otherwise occur. Indeed, it has been proposed that undocumented (or silent) infections are the source for almost 80% of documented infections; thus, it is critical to determine the silent and symptomatic infection rate in children. To overcome challenges for clinical study implementation imposed by current healthcare access restrictions, a surveillance study under design will enroll and prospectively observe eligible children, and their family members, that are current participants in our NIH-funded, ongoing, birth cohort studies. These children and their families are known to research staff and as part of their participation in HFHS studies, they have already been exposed to the procedures involved in a surveillance study. We are requesting support for the pediatric studies aligned with our Microbiota and Allergic Asthma Precision Prevention (MAAP2) (PI: Johnson, Ownby P01AI089473) to participate in the multi-center survey entitled Human Epidemiology and Response to SARS-CoV-2 (HEROS), Protocol # DAIT-COVID-19-001. Our primary objective is to report the incidence of SARS-CoV-2 infection (detection of virus in nasal secretions) over time in cohort children (index child) and household contacts (caregivers and siblings). A secondary objective is to compare SARS-CoV-2 infection status and antibody development for index children/siblings with atopic conditions (e.g. asthma, eczema) versus children without atopic conditions. As an exploratory aim, we will investigate whether SARS-CoV-2 infection (as determined by virus detected in nasal secretions) is associated with the presence of virus in stool. Our targeted enrollment is 300 families recruited over a 2-week period and followed for a minimum of 6 months. At predetermined intervals, biological samples (nasal swabs, peripheral blood, stool) will be collected by the caregiver at home using materials provided to the family. Symptom and exposure surveys will be completed remotely via a smart phone, on-line, or telephone at the time of biological sample collection. This timely, multi-site study can be rapidly implemented and realistically conducted without necessitating any visits to a clinical research center and will provide invaluable information on the infection burden of SARS-CoV-2 in children.