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

NCT04375761 | Completed Results

• 1 other identifier: DAIT-COVID-19-001
• Study Type: observational
• Target: 5,599
• Locations: 1 country
• Sites: 20

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

Conditions

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

Keywords

COVID-19; SARS-CoV-2; Public Health Surveillance; Participants in NIH-funded studies (and their families)

Outcome Measures

Primary Outcomes (1)

• Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period

  Nasal samples were analyzed to determine whether a participant ever tested positive for SARS-CoV-2 or not over the course of the study. Kaplan-Meier was used to estimate survival probabilities at timepoints throughout the study. Participants were censored if they did not test positive for SARS-CoV-2 by the end of follow-up. The last positive nasal swab occurred at day 212.

  Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)

Secondary Outcomes (9)

• Percent of Index Participants and Their Household Contacts With Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period

  Up to Week 24

• Number of Index Participants With SARS-CoV-2 Detection in Nasal Samples With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period

  Up to Week 24

• Percent of Index Participants With Asthma and Other Atopic Disease With Detectable SARS-CoV-2-Specific Antibodies in Serum Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period

  Through study completion, an average of 24 Weeks

• Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period

  Up to Week 24

• Changes in the Nasal Transcriptome Associated With Detection of SARS-CoV-2 in Nasal Samples Among Index Participants With Asthma and Other Atopic Disease Compared to Index Participants Without Atopic Disease Over the Study/Surveillance Period

  Up to Week 24

Study Arms (1)

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.

Procedure: Collection of Biological Samples; Procedure: Symptom and Exposure Surveys

Interventions

Collection of Biological Samples PROCEDURE

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

Symptom and Exposure Surveys PROCEDURE

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.

Also known as: Symptom and Exposure Questionnaires

SARS-CoV-2 Surveillance: Total Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NIH-funded study participants (index participants) and their families This includes participants who have asthma and/or other atopic or allergic conditions, as well as healthy index participants, all with extensive medical information and information on atopic and allergic status available as a result of their participation in an NIH-funded study. As many of these are birth cohort studies, there is extensive information available on the parents. The majority of the families have experience with collection of respiratory samples and completing respiratory questionnaires.

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (20)

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

Aurora, Colorado, 80045, United States

Location

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

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site

Washington D.C., District of Columbia, 20010, United States

Location

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, United States

Location

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

Boston, Massachusetts, 02114, United States

Location

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, United States

Location

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

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System: Childhood Allergy Study (CAS) Site

Detroit, Michigan, 48202, United States

Location

Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site

Detroit, Michigan, 48202, United States

Location

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, United States

Location

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

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center: Inner City Asthma Consortium (ICAC) Site

New York, New York, 10032, United States

Location

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, United States

Location

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

Cincinnati, Ohio, 45229, United States

Location

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

Cincinnati, Ohio, 45229, United States

Location

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

Cincinnati, Ohio, 45229, United States

Location

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

Nashville, Tennessee, 37232, United States

Location

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

Dallas, Texas, 75390, United States

Location

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

Madison, Wisconsin, 53792, United States

Location

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

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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, Rivera-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 Dec 20;232(6):e920-e930. doi: 10.1093/infdis/jiaf374.

  PMID: 40795882 DERIVED

• 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.

  PMID: 38775275 DERIVED

Related Links

• National Institute of Allergy and Infectious
• Division of Allergy, Immunology, and Transplantation

Biospecimen

Retention: SAMPLES WITH DNA

Nasal, peripheral blood and stool samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

34.4% of nasal collections were missed during the study period.

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Tina V. Hartert, MD, MPH

  Vanderbilt University School of Medicine, Dept. of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: May 1, 2020
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: August 6, 2025
• Results First Posted: December 5, 2023

Record last verified: 2025-07

Locations

US (20)