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

NCT ID: NCT04757831

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2026-02-15

Brief Summary

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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).

Detailed Description

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Conditions

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Covid19; MIS-C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kanecia Zimmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Related Links

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https://abcsciencecollaborative.org/

This study is a part of the ABC Science Collaborative.

Other Identifiers

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Pro00107647

Identifier Type: -

Identifier Source: org_study_id

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