Human Epidemiology and Response to SARS-CoV-2 (HEROS)

本申请是对NOT-AI-20-031的回应，旨在为应对CoVID 19紧急情况提供补充资金。由SARS-CoV-2引起的传染病COVID-19正在迅速影响 地球仪上的人类。虽然最初的流行病学数据集中在以下病例， 导致严重的呼吸道疾病，主要见于成人， 儿童的感染负担是可用的。这是复杂的观察，许多 经病毒学确诊的儿童病例无症状。没有记录，很可能 传染性，病例可能会导致接触到更大比例的社区， 否则会发生。事实上，有人提出，无记录（或沉默）的感染 是近80%记录在案的感染的来源;因此，确定沉默的 和儿童有症状感染率。克服临床研究的挑战 目前的医疗保健准入限制所施加的实施，根据 设计将招募并前瞻性观察符合条件的儿童及其家庭成员， 目前参与我们NIH资助的正在进行的出生队列研究。这些儿童及其 研究人员了解家庭，作为他们参与HFHS研究的一部分，他们 已经接触过监测研究中涉及的程序。我们要求 支持与我们的微生物群和过敏性哮喘精确度相一致的儿科研究 预防（MAAP 2）（PI：约翰逊，Ownby P01 AI 089473）参与多中心研究 题为"人类流行病学和对SARS-CoV-2的反应“的调查，第#号议定书 DAIT-COVID-19-001。我们的主要目的是报告SARS-CoV-2感染的发病率 队列儿童（索引儿童）和家庭中随时间推移的病毒（鼻分泌物中的病毒检测） 联系人（照顾者和兄弟姐妹）。次要目的是比较SARS-CoV-2感染 患有特应性病症（例如哮喘， 湿疹）与无特应性病症的儿童相比。作为一个探索性的目标，我们将调查 SARS-CoV-2感染（通过鼻分泌物中检测到的病毒确定）是否 与粪便中存在病毒有关。我们的目标是招募300个家庭 在2周的时间内，并随访至少6个月。以预定的间隔， 生物样本（鼻拭子、外周血、粪便）将由护理人员在 使用提供给家庭的材料。将完成症状和暴露调查 在生物样品收集时，通过智能电话、在线或电话远程监测。 这项及时的多地点研究可以迅速实施，并切实可行， 需要对临床研究中心进行任何访问，并将提供以下方面的宝贵信息 SARS-CoV-2在儿童中的感染负担。

This request is in response to NOT-AI-20-031 for supplement funding in response to the CoVID19 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.