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

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 affectinghumans around the globe. While initial epidemiological data have focused on cases thatresulted in severe respiratory disease seen predominantly in adults, little information regardingthe infection burden in children is available. This is complicated by the observation that manyvirologically-confirmed cases in children are asymptomatic. Undocumented, and likelyinfectious, cases could result in exposure to a far greater proportion of the community thanwould otherwise occur. Indeed, it has been proposed that undocumented (or silent) infectionsare the source for almost 80% of documented infections; thus, it is critical to determine the silentand symptomatic infection rate in children. To overcome challenges for clinical studyimplementation imposed by current healthcare access restrictions, a surveillance study underdesign will enroll and prospectively observe eligible children, and their family members, that arecurrent participants in our NIH-funded, ongoing, birth cohort studies. These children and theirfamilies are known to research staff and as part of their participation in HFHS studies, they havealready been exposed to the procedures involved in a surveillance study. We are requestingsupport for the pediatric studies aligned with our Microbiota and Allergic Asthma PrecisionPrevention (MAAP2) (PI: Johnson, Ownby P01AI089473) to participate in the multi-centersurvey 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 householdcontacts (caregivers and siblings). A secondary objective is to compare SARS-CoV-2 infectionstatus 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 investigatewhether SARS-CoV-2 infection (as determined by virus detected in nasal secretions) isassociated with the presence of virus in stool. Our targeted enrollment is 300 families recruitedover 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 athome using materials provided to the family. Symptom and exposure surveys will be completedremotely 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 withoutnecessitating any visits to a clinical research center and will provide invaluable information onthe infection burden of SARS-CoV-2 in children.