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

Withdrawn

• Conditions: Covid19; MIS-C

• Registration Number: NCT04757831
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-16
• Study Start: 2021-10-15
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C).	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

Name	Time	Method
Characterize outcomes associated with COVID-19 in children.	Up to 5 years	Incidence of COVID-19 vaccination from baseline to the end of study.
Describe characteristics of participants who attend in-person versus virtual classes.	Up to 5 years	Baseline demographics of those who attend in-person classes compared to those who do not.
Describe risk factors of non-severe and severe COVID-19.	Up to 5 years	Type of COVID-19 exposure (e.g. household, school-related, travel, other, unknown)
Describe the duration of in-person school attendance.	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.