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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375761
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
Rho Federal Systems Division, Inc. (Rho)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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

Condition or disease Intervention/treatment
Coronavirus Disease 2019 (COVID-19) SARS-CoV-2 Procedure: Collection of Biological Samples Procedure: Symptom and Exposure Surveys

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.

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Study Type : Observational
Actual Enrollment : 5605 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Human Epidemiology and Response to SARS-CoV-2 (DAIT-COVID-19-001)
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 Name: Symptom and Exposure Questionnaires




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.


Biospecimen Retention:   Samples With DNA
Nasal, peripheral blood and stool samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375761


Locations
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Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Rho Federal Systems Division, Inc. (Rho)
Investigators
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Study Chair: Tina V. Hartert, MD, MPH Vanderbilt University School of Medicine, Dept. of Medicine
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04375761    
Other Study ID Numbers: DAIT-COVID-19-001
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
COVID-19
SARS-CoV-2
Public Health Surveillance
Participants in NIH-funded studies (and their families)
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases