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History of Changes for Study: NCT04375761
COVID-19: Human Epidemiology and Response to SARS-CoV-2 (HEROS)
Latest version (submitted February 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 4, 2020 None (earliest Version on record)
2 May 8, 2020 Contacts/Locations and Study Status
3 May 13, 2020 Recruitment Status, Study Status and Contacts/Locations
4 May 14, 2020 Contacts/Locations and Study Status
5 May 15, 2020 Contacts/Locations and Study Status
6 May 22, 2020 Contacts/Locations and Study Status
7 June 24, 2020 Study Status and Contacts/Locations
8 June 26, 2020 Recruitment Status, Study Design and Study Status
9 August 5, 2020 Sponsor/Collaborators, Study Status and Study Design
10 January 19, 2021 Study Status
11 February 11, 2021 Recruitment Status, Study Status and Study Design
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Study NCT04375761
Submitted Date:  May 4, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: DAIT-COVID-19-001
Brief Title: COVID-19: Human Epidemiology and Response to SARS-CoV-2 (HEROS)
Official Title: Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Recruiting
Study Start: May 1, 2020
Primary Completion: December 2020 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: April 30, 2020
First Submitted that
Met QC Criteria:
May 4, 2020
First Posted: May 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 4, 2020
Last Update Posted: May 5, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor
Collaborators: Rho, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
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)
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Family-Based
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Nasal, peripheral blood and stool samples
Enrollment: 8000 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
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.

Other Names:
  • Symptom and Exposure Questionnaires
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Cumulative Incidence of SARS-CoV-2 RNA Detection in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
[ Time Frame: Up to Week 24 ]

Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts.

Calculated at the end of surveillance/study follow-up or fate, defined as follows:

  1. Time from entry until the first of the following events:
    • Tests positive for SARS-CoV-2 RNA in nasal samples
    • Is lost to follow-up or withdraws from the study
    • End of study (Week 24)
  2. Fate at the end of follow-up:
    • 1 (positive): If the participant tests positive for SARS-CoV-2
    • 0 (censored): If the participant has no evidence of having had disease by the end of follow-up
Secondary Outcome Measures:
1. Percent of Index Participants and Their Household Contacts with Detectable SARS-CoV-2-Specific Antibodies in Serum Over the Study/Surveillance Period
[ Time Frame: Up to Week 24 ]

Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts.

Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).

2. Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants with Asthma and Other Atopic Disease Compared to Index Participants without Atopic Disease Over the Study/Surveillance Period
[ Time Frame: Up to Week 24 ]

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.

Testing method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.

3. 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
[ Time Frame: Through study completion, an average of 24 Weeks ]

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.

Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).

4. 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
[ Time Frame: Up to Week 24 ]

Nasal samples of participants currently or previously enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts that test positive for SARS-CoV-2, will undergo transcriptome analysis.

Total RNA will be isolated for cDNA synthesis and amplification. Differential gene expression analysis be pursued.

5. 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
[ Time Frame: Up to Week 24 ]

Nasal samples of index participants that test positive for SARS-CoV-2 will be evaluated by transcriptome analysis. Differential gene expression analysis at different timepoints in the disease process will be analyzed.

Definition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.

6. Symptoms Associated with Detection of SARS-CoV-2 in Nasal Samples Among Index Participants and Their Household Contacts Over the Study/Surveillance Period
[ Time Frame: Up to Week 24 ]

An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted.

Included in analysis: Index participants and their household contacts.

7. Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants using Topical Steroids Compared to Index Participants that are Not Using Topical Steroids Over the Study/Surveillance Period
[ Time Frame: Up to Week 24 ]

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.

Tests:Positive for SARS-CoV-2 RNA in nasal samples

8. Cumulative Incidence of SARS-CoV-2 Detection in Nasal Samples Among Index Participants Using Topical, Oral, or Inhaled Steroids Compared to Index Participants that are Not Using Topical, Oral, or Inhaled Steroids During the Study/Surveillance Period
[ Time Frame: Up to Week 24 ]

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria.

Tests: Positive for SARS-CoV-2 RNA in nasal samples.

9. Analysis of Factors, Baseline and Prior History, for Possible Association with the Cumulative Incidence of SARS-COV-2 Detection in Nasal Samples: Index Participants and Their Household Contacts Over the Study/Surveillance Period
[ Time Frame: Baseline, Week 24 ]

An exploratory analysis will be conducted for detection of possible associations, focusing on baseline demographic and environment factors and/or history of bronchiolitis prior history with the cumulative incidence of SARS-CoV-2 detection in nasal samples Test: Positive for SARS-CoV-2 RNA in nasal samples.
Open or close this module Eligibility
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.
Sampling Method: Probability Sample
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Study Officials: Tina V. Hartert, MD, MPH
Study Chair
Vanderbilt University School of Medicine, Dept. of Medicine
Locations: United States, Colorado
Children's Hospital Colorado: Inner City Asthma Consortium (ICAC) Site
[Recruiting]
Aurora, Colorado, United States, 80045
Contact:Contact: Pascuala Pinedo-Estrada 720-777-8077 pascuala.pinedo-estrada@childrenscolorado.org
Contact:Principal Investigator: Andrew Liu, MD
United States, District of Columbia
Children's National Medical Center: Inner City Asthma Consortium (ICAC) Site
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: Tiffany Ogundipe 202-476-2943 togundipe@childrensnational.org
Contact:Principal Investigator: Stephen Teach, MD
United States, Massachusetts
Boston Medical Center: Inner City Asthma Consortium (ICAC) Site
[Recruiting]
Boston, Massachusetts, United States, 02118
Contact:Contact: Nicole Gonzalez 617-414-3336 nicolegg@bu.edu
Contact:Principal Investigator: George T. O'Connor, MD, MS
United States, Michigan
Henry Ford Health System: Inner City Asthma Consortium (ICAC) Site
[Recruiting]
Detroit, Michigan, United States, 48202
Contact:Contact: Sherae Hereford 313-916-6954 sherefo3@hfhs.org
Contact:Principal Investigator: Edward Zoratti, MD
Henry Ford Health System: Microbes, Asthma, Allergy and Pets (MAAP) and Wayne County Health, Environment, Allergy, and Asthma Longitudinal Study (WHEALS) Site
[Recruiting]
Detroit, Michigan, United States, 48202
Contact:Contact: Kyra Jones 513-803-8000 kjones20@hfhs.org
Contact:Contact: Amanda Cyrus 513-803-8000 acyrus1@HFHS.org
Contact:Principal Investigator: Christine C. Johnson, PhD
Contact:Principal Investigator: Edward Zoratti, MD
United States, Missouri
St. Louis Children's Hospital: Inner City Asthma Consortium (ICAC) Site
[Recruiting]
Saint Louis, Missouri, United States, 63110
Contact:Contact: Elizabeth Tesson 314-286-1290 tesson.elizabeth@wustl.edu
Contact:Principal Investigator: Leonard B. Bacharier, MD
United States, Ohio
Cincinnati Children's Hospital Medical Center: Greater Cincinnati Pediatric Clinic Repository (GCPCR) and Mechanisms of Progression of Atopic Dermatitis to Asthma in Children (IMPAACH) Site
[Recruiting]
Cincinnati, Ohio, United States, 45229
Contact:Contact: Asel Baatyrbek 513-803-8000 Asel.Baatyrbekkyzy@cchmc.org
Contact:Principal Investigator: Gurjit K. Khurana Hershey, MD, PhD
Cincinnati Children's Hospital Medical Center: Inner City Asthma Consortium (ICAC) Site
[Recruiting]
Cincinnati, Ohio, United States, 45229
Contact:Contact: Pamela Groh 513-803-9212 pam.groh@cchmc.org
Contact:Principal Investigator: Gurjit K. Khurana Hershey, MD, PhD
Cincinnati Children's Hospital Medical Center:Cincinnati Childhood Allergy & Air Pollution Study (CCAAPS) Site
[Recruiting]
Cincinnati, Ohio, United States, 45229
Contact:Contact: Zachary Flege 513-636-1411 Zachary.Flege@cchmc.org
Contact:Principal Investigator: Gurjit K. Khurana Hershey, MD, PhD
United States, Tennessee
Vanderbilt University Medical Center: Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE) Site
[Recruiting]
Nashville, Tennessee, United States, 37232
Contact:Contact: Alexandra Connolly 615-875-7448 alexandra.s.connolly@vumc.org
Contact:Principal Investigator: Tina V. Hartert, MD, MPH
United States, Texas
University of Texas Southwestern Medical Center: Inner City Asthma Consortium (ICAC) Site
[Recruiting]
Dallas, Texas, United States, 75390
Contact:Contact: Dolores Santoyo 214-648-2620 dolores.santoyo@utsouthwestern.edu
Contact:Principal Investigator: Rebecca Gruchalla, MD
United States, Wisconsin
University of Wisconsin Hospital and Clinics: Childhood Origins of Asthma (COAST) Site
[Recruiting]
Madison, Wisconsin, United States, 53792
Contact:Contact: Jen Smith 608-228-9590 jmsmith@medicine.wisc.edu
Contact:Principal Investigator: Daniel J. Jackson, MD
University of Wisconsin Hospital and Clinics: Wisconsin Infant Study Cohort (WISC) Site
[Recruiting]
Madison, Wisconsin, United States, 53792
Contact:Contact: Kyle Koshalek 715-389-3786 koshalek.kyle@marshfieldresearch.org
Contact:Principal Investigator: Christine M. Seroogy, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: National Institute of Allergy and Infectious
Description: Division of Allergy, Immunology, and Transplantation
Available IPD/Information:

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