Human epidemiology and response to SARS-CoV-2 (HEROS)

NIH RePORTER · NIH · UM1 · $403,137 · view on reporter.nih.gov ↗

Abstract

COVID-19 SURVEILLANCE STUDY SARS-CoV2 causes severe respiratory disease seen predominantly in adults (COVID-19), but there is little information regarding the infection burden in children. 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 (Li et al, Science); 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, we propose a surveillance study to determine the prevalence of SARS-CoV2 infection (detection of virus in nasal secretions) over time in children and their household contacts (caregivers and siblings). In addition to the need for surveying children for asymptomatic SARS-CoV-2 infection, this study will allow a comparison between children with asthma and other atopic conditions and children without those conditions. Figure 3.1 Study Overview Study design We propose to conduct a prospective surveillance study in which children (index child) and their household contacts, including caregiver(s) and siblings, will be enrolled at study sites with NIH-funded studies. Potential participants are those enrolled in existing NIH-funded studies (including the Wisconsin Infant Cohort Study, the Childhood Origins of Asthma [COAST] study, the MUPPITS-2 study, the RACR study and the Urban Environment and Childhood Asthma [URECA] study). The intent is to recruit children who have asthma and/or other atopic conditions, as well as healthy children, with extensive medical information and information on atopic status available as part of their participation in cohort studies. The enrollment goal is approximately 2000 families to be enrolled over approximately 2 weeks, and each participant will be observed for 6 months. During the study, biological samples will be collected by the family at pre-determined intervals and symptom and exposure surveys will be completed on-line at the time the biological samples are collected (Figure 1 Study Overview). Some biological samples (nasal swabs and stool) will be collected by the caregiver at home. Blood samples will be collected at a home study visit or at an independent clinical laboratory, depending on feasibility. Samples will be processed in central laboratories, and Rho Inc. will serve as the coordinating center for the study. The primary outcome of the study will be the percent of index children and their household contacts with detectable SARS-CoV2 in nasal secretions. Secondary and exploratory outcomes are as described in the study protocol. Project Summary (Primary award-ICAC) The overall goals of our proposal are designed to address current high priori...

Key facts

NIH application ID
10230381
Project number
3UM1AI114271-07S2
Recipient
UNIVERSITY OF WISCONSIN-MADISON
Principal Investigator
James E. Gern
Activity code
UM1
Funding institute
NIH
Fiscal year
2021
Award amount
$403,137
Award type
3
Project period
2020-11-09 → 2021-07-31