NCT04375761

COVID-19: Human Epidemiology and Response to SARS-CoV-2

Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,599 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Detailed description

The study population will include children that are participants in NIH-funded cohort studies and their families (household contacts).The intent is to recruit families that have experience with the collection of respiratory samples. The objective of this surveillance study is to identify the rate of infection in children and what, if any effect, atopy has on the SARS-CoV-2 carrier status. The initial surveillance interval for participants will be 6 months and, depending upon the findings, may be extended. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed remotely via a smart phone, on-line, or phone communications at the time the biological samples are collected.

Conditions

• Coronavirus Disease 2019 (COVID-19)
• SARS-CoV-2

Interventions

Type	Name	Description
PROCEDURE	Collection of Biological Samples	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.
PROCEDURE	Symptom and Exposure Surveys	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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-03-29
• Completion: 2021-03-29
• First posted: 2020-05-05
• Last updated: 2025-08-06
• Results posted: 2023-12-05

Locations

20 sites across 1 country: United States