At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)
In Brief
An observational study evaluating Collection of Biological Samples and Symptom and Exposure Surveys for Coronavirus Disease 2019 (COVID-19) and SARS-CoV-2. Completed, enrolled 5,599 participants across 20 sites.
Detailed Summary
The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 presents as a mild to moderate respiratory illness. But it can also be more severe and even lead to death. The purpose of this study is to: * Determine the prevalence of SARS-CoV-2 carrier status over time in children and parents * Determine the prevalence of antibody development over time in children and parents * Compare carrier status and antibody development for children with asthma and/or other atopic conditions (e.g. eczema) versus children without asthma and/or other atopic conditions * Investigate the presence of SARS-CoV-2 exposure in historical samples from enrolled participants
Study Details
Timeline
Interventions
Biological samples will be collected throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. All biological samples (e.g. nasal swabs, peripheral blood, stool) will be collected by the caregiver at home using materials provided to the family. At the end of study, additional samples (e.g. nasal secretion and/or saliva samples) may be collected by the family or study staff at a site visit, if feasible.
Symptom and exposure surveys (questionnaires) will be completed throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. The primary household contact/caregiver will be the designee for ensuring timely questionnaires completion and submission for all household study participants.