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Coronavirus-19 (COVID-19) and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)

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ClinicalTrials.gov Identifier: NCT04757831
Recruitment Status : Not yet recruiting
First Posted : February 17, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This is a prospective, observational study with a primary objective of determining the incidence of non-severe and severe COVID-19, including MIS-C, among eligible children who are diagnosed with COVID-19 and consent (or assent) to collection of data on risk factors using a unique direct-to-participant, direct-to-family, and direct-to-community approach. Secondary and exploratory objectives include risk factors of severe disease and quality of life (QoL).

Condition or disease
Covid19; MIS-C

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Study Type : Observational
Estimated Enrollment : 1000000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of COVID-19 and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
Estimated Study Start Date : July 15, 2021
Estimated Primary Completion Date : February 15, 2026
Estimated Study Completion Date : February 15, 2026



Primary Outcome Measures :
  1. Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C). [ Time Frame: 90 days ]
    Number of participants who report non-severe or severe COVID-19 disease (defined as a hospitalization event, severe neurological dysfunction, occurrence of MIS-C, or death within 90 days of infection with SARS-CoV-2), reported as a proportion (%) of the total number of participants enrolled in the study who develop non-severe and severe COVID-19 from the time of study initiation to the end of study.


Secondary Outcome Measures :
  1. Describe risk factors of non-severe and severe COVID-19. [ Time Frame: Up to 5 years ]
    Demographic variables (e.g. English proficiency, internet access, school district, age, race)

  2. Describe risk factors of non-severe and severe COVID-19. [ Time Frame: Up to 5 years ]
    COVID-19-related symptoms (e.g. cough, fever, shortness of breath, headache, loss of smell)

  3. Describe risk factors of non-severe and severe COVID-19. [ Time Frame: Up to 5 years ]
    Type of COVID-19 exposure (e.g. household, school-related, travel, other, unknown)

  4. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Incidence of subsequent exposures to COVID-19 from baseline to the end of study.

  5. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Incidence of ongoing COVID-19 symptoms from baseline to the end of study.

  6. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Duration of ongoing COVID-19 symptoms from baseline to the end of study.

  7. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Incidence of hospitalizations from baseline to the end of study.

  8. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Duration of hospitalizations from baseline to the end of study.

  9. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Incidence of neurologic complications from baseline to the end of study.

  10. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Duration of neurologic complications from baseline to the end of study.

  11. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Incidence of COVID-19 vaccination from baseline to the end of study.

  12. Describe characteristics of participants who attend in-person versus virtual classes. [ Time Frame: Up to 5 years ]
    Baseline demographics of those who attend in-person classes compared to those who do not.

  13. Describe the duration of in-person school attendance. [ Time Frame: Up to 5 years ]
    Average in-person attendance from the first day of school to the last day of school among participants compared to the national average during each school year.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants ≤ 21 years of age who have a COVID-19 diagnosis.
Criteria

Inclusion Criteria:

  • Participant is ≤ 21 years of age at time of enrollment
  • Participant or their parent/guardian has downloaded the "ABC Science" App from the App store as a part of the ABC Science Collaborative (Pro00107785) and has agreed to the App's Terms of Use
  • Participant has a positive COVID-19 diagnosis, defined as one or more of the following:

    1. A positive COVID-19 test; or
    2. Clinical diagnosis of COVID-19 based on symptoms, as documented by a medical provider, in the absence of a positive influenza test; or
    3. Retrograde diagnosis based on presence of COVID-19 antibodies

Exclusion Criteria:

  • N/A

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): NCT04757831


Contacts
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Contact: Helen Bristow, MPH 919-668-3687 abcscienceregistry@duke.edu
Contact: Tara Mann, PhD, RN abcscienceregistry@duke.edu

Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Kanecia Zimmerman, MD Duke University
Additional Information:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04757831    
Other Study ID Numbers: Pro00107647
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No