COVID-19: Human Epidemiology and Response to SARS-CoV-2
NCT ID: NCT04375761
Last Updated: 2025-08-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
5599 participants
OBSERVATIONAL
2020-05-01
2021-03-29
Brief Summary
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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
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Detailed Description
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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
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Study Design
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FAMILY_BASED
PROSPECTIVE
Study Groups
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SARS-CoV-2 Surveillance: Total Group
Participants either currently or in the past, enrolled in National Institutes of Health (NIH)-funded cohort studies, and their families (household contacts).
Active surveillance for detection of SARS-CoV-2 for 6 months, beginning with enrollment. During surveillance, biological samples will be collected by the family at established intervals and symptom and exposure surveys will be completed at the time that biological samples are collected.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
Yes
Sponsors
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Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Tina V. Hartert, MD, MPH
Role: STUDY_CHAIR
Vanderbilt University School of Medicine, Dept. of Medicine
Locations
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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
Countries
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References
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Moore CM, Secor EA, Everman JL, Fairbanks-Mahnke A, Jackson N, Pruesse E, Diener K, Morin A, Arbes SJ, Bacharier LB, Bendixsen CG, Calatroni A, Dupont WD, Furuta GT, Gebretsadik T, Gruchalla RS, Gupta RS, Khurana Hershey GK, Kattan M, Liu AH, Lussier SJ, Murrison LB, Numata M, O'Connor GT, River-Spoljaric K, Phipatanakul W, Rothenberg ME, Seroogy CM, Zoratti EM, Castina S, Jackson DJ, Camargo CA Jr, Johnson CC, Ethridge R, Ramratnam S, Stelzig L, Teach SJ, Togias AG, Fulkerson PC, Hartert TV, Seibold MA. The common cold is associated with protection from SARS-CoV-2 Infections. J Infect Dis. 2025 Aug 11:jiaf374. doi: 10.1093/infdis/jiaf374. Online ahead of print.
Fulkerson PC, Lussier SJ, Bendixsen CG, Castina SM, Gebretsadik T, Marlin JS, Russell PB, Seibold MA, Everman JL, Moore CM, Snyder BM, Thompson K, Tregoning GS, Wellford S, Arbes SJ, Bacharier LB, Calatroni A, Camargo CA Jr, Dupont WD, Furuta GT, Gruchalla RS, Gupta RS, Hershey GK, Jackson DJ, Johnson CC, Kattan M, Liu AH, Murrison L, O'Connor GT, Phipatanakul W, Rivera-Spoljaric K, Rothenberg ME, Seroogy CM, Teach SJ, Zoratti EM, Togias A, Hartert TV, Heros Study Team OBOT. Human Epidemiology and Response to SARS-CoV-2 (HEROS): objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods. Am J Epidemiol. 2024 Oct 7;193(10):1329-1338. doi: 10.1093/aje/kwae077.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Final ICF
Document Type: Informed Consent Form: Adjustment ICF
Related Links
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National Institute of Allergy and Infectious
Division of Allergy, Immunology, and Transplantation
Other Identifiers
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DAIT-COVID-19-001
Identifier Type: -
Identifier Source: org_study_id
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