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

Completed

Conditions studied: Coronavirus Disease 2019 (COVID-19), SARS-CoV-2

In brief

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

Key facts

Study ID

NCT04375761

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

5599

Starts

2020-05-01

Expected to finish

2021-03-29

Last updated by the study team

2025-08-06

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site — Aurora, Colorado, United States
• Children's Hospital Colorado: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site — Aurora, Colorado, United States
• Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site — Washington D.C., District of Columbia, United States
• 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, United States
• Massachusetts General Hospital:Childhood Microbiome (CHIME) and Wheezing Index (WIND) Site — Boston, Massachusetts, United States
• 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, United States
• Boston Medical Center: Inner City Asthma Consortium (ICAC) Site — Boston, Massachusetts, United States
• Henry Ford Health System: Childhood Allergy Study (CAS) Site — Detroit, Michigan, United States
• Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site — Detroit, Michigan, United States
• Henry Ford Health System: Microbes, Asthma, Allergy and Pets (MAAP) and Wayne County Health, Environment, Allergy, and Asthma Longitudinal Study (WHEALS) Site — Detroit, Michigan, United States
• St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site — St Louis, Missouri, United States
• Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site — New York, New York, United States
• 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, United States
• Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages (OMEGA) Site — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site — Dallas, Texas, United States
• University of Wisconsin Hospital and Clinics: Childhood Origins of Asthma (COAST) Site — Madison, Wisconsin, United States
• University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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