Official Title
Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)
Brief 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.

Active, not recruiting
Coronavirus Disease 2019 (COVID-19)
SARS-CoV-2

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.
SARS-CoV-2 Surveillance: Total Group

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.
SARS-CoV-2 Surveillance: Total Group
Other Name: Symptom and Exposure Questionnaires

Eligibility Criteria

Inclusion Criteria:

Household members who meet all of the following criteria are eligible for enrollment as
study participants: - The index participant, defined as an individual who either is or has been a participant in an NIH-funded clinical research study from which information on respiratory conditions, including asthma, and other atopic and allergic diseases is available, is: - ≤21 years of age, and - Lives with caregiver(s). - The index participant and/or caregiver understands the study procedures and is willing to conduct these procedures at home; - Have the ability to use either a computer or a smart phone to link to and respond to the study questionnaires: --Exception: When the family is willing to speak with a study member to answer the questionnaires in the event of not having access to a computer or a smart phone. - The index participant and caregiver will reside in the United States, including Puerto Rico, for the duration of the study; - The index participant will live with the caregiver for at least 50% of the time for the duration of the study; - An English or Spanish speaker is available to: - Serve as the primary contact, and - As the person who will be responsible for the completion of questionnaires and the collection of study biological samples; and, - To participate as a sibling (of the index participant), must be under 21 years of age and live in the same home as the index participant and caregiver.

Exclusion Criteria:

-Past or current medical problems, which, in the opinion of the site investigator may: - Pose risks from participation in the study - Interfere with the participant's ability to comply with study requirements, or - Impact the quality or interpretation of the data obtained from the study.

Eligibility Gender
All
Countries
United States
Locations

Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site
Aurora, Colorado, 80045

Children's Hospital Colorado: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site
Aurora, Colorado, 80045

Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site
Washington, District of Columbia, 20010

Ann & Robert H. Lurie Children's Hospital of Chicago: Food Allergy Outcomes Related to White and African American Racial Differences (FORWARD) and Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) Site
Chicago, Illinois, 60611

Massachusetts General Hospital:Childhood Microbiome (CHIME) and Wheezing Index (WIND) Site
Boston, Massachusetts, 02114

Boston Children's Hospital: School Inner-City Asthma Study (SICAS-2), Environmental Assessment of Sleep in Youth (EASY), Severe Asthma Research Program (SARP) and Preventing Asthma in High Risk Kids (PARK) Site
Boston, Massachusetts, 02115

Boston Medical Center: Inner City Asthma Consortium (ICAC) Site
Boston, Massachusetts, 02118

Henry Ford Health System: Childhood Allergy Study (CAS) Site
Detroit, Michigan, 48202

Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site
Detroit, Michigan, 48202

Henry Ford Health System: Microbes, Asthma, Allergy and Pets (MAAP) and Wayne County Health, Environment, Allergy, and Asthma Longitudinal Study (WHEALS) Site
Detroit, Michigan, 48202

St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site
Saint Louis, Missouri, 63110

Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site
New York, New York, 10032

Cincinnati Children's Hospital Medical Center: Greater Cincinnati Pediatric Clinic Repository (GCPCR) and Mechanisms of Progression of Atopic Dermatitis to Asthma in Children (MPAACH) Site
Cincinnati, Ohio, 45229

Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site
Cincinnati, Ohio, 45229

Cincinnati Children's Hospital Medical Center: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site
Cincinnati, Ohio, 45229

Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site
Cincinnati, Ohio, 45229

Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site
Nashville, Tennessee, 37232

University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site
Dallas, Texas, 75390

University of Wisconsin Hospital and Clinics: Childhood Origins of Asthma (COAST) Site
Madison, Wisconsin, 53792

University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site
Madison, Wisconsin, 53792

Tina V. Hartert, MD, MPH
Study Chair
Vanderbilt University School of Medicine, Dept. of Medicine

National Institute of Allergy and Infectious Diseases (NIAID)
Rho Federal Systems Division, Inc. (Rho)
NCT Number
Keywords
Covid-19
SARS-CoV-2
Public Health Surveillance
Participants in NIH-funded studies (and their families)
MeSH Terms
Coronavirus Infections