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

NCT04375761 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5599

Last updated 2025-08-06

Study results available
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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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Tina V. Hartert, MD, MPH · Vanderbilt University School of Medicine, Dept. of Medicine

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-03-29
Completion
2021-03-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375761 on ClinicalTrials.gov