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

A Prospective Study of COVID-19 and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)

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).

Study Overview

• Status: Withdrawn
• Conditions: Covid19; MIS-C

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants ≤ 21 years of age who have a COVID-19 diagnosis.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C).	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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe risk factors of non-severe and severe COVID-19.	Demographic variables (e.g. English proficiency, internet access, school district, age, race)	Up to 5 years
Describe risk factors of non-severe and severe COVID-19.	COVID-19-related symptoms (e.g. cough, fever, shortness of breath, headache, loss of smell)	Up to 5 years
Describe risk factors of non-severe and severe COVID-19.	Type of COVID-19 exposure (e.g. household, school-related, travel, other, unknown)	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Incidence of subsequent exposures to COVID-19 from baseline to the end of study.	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Incidence of ongoing COVID-19 symptoms from baseline to the end of study.	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Duration of ongoing COVID-19 symptoms from baseline to the end of study.	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Incidence of hospitalizations from baseline to the end of study.	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Duration of hospitalizations from baseline to the end of study.	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Incidence of neurologic complications from baseline to the end of study.	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Duration of neurologic complications from baseline to the end of study.	Up to 5 years
Characterize outcomes associated with COVID-19 in children.	Incidence of COVID-19 vaccination from baseline to the end of study.	Up to 5 years
Describe characteristics of participants who attend in-person versus virtual classes.	Baseline demographics of those who attend in-person classes compared to those who do not.	Up to 5 years
Describe the duration of in-person school attendance.	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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Duke University

Publications and helpful links

Helpful Links

• This study is a part of the ABC Science Collaborative.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2021
• Primary Completion (ANTICIPATED): February 15, 2026
• Study Completion (ANTICIPATED): February 15, 2026

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (ACTUAL): February 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00107647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No