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

Covid19; MIS-C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04757831
• Other study ID #: Pro00107647
• Status: Withdrawn
• Start date: October 15, 2021
• Est. completion date: February 15, 2026

Study information

• Verified date: February 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2026
• Est. primary completion date: February 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19; MIS-C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Characterize outcomes associated with COVID-19 in children.	Incidence of hospitalizations from baseline to the end of study.	Up to 5 years
Secondary	Characterize outcomes associated with COVID-19 in children.	Duration of hospitalizations from baseline to the end of study.	Up to 5 years
Secondary	Characterize outcomes associated with COVID-19 in children.	Incidence of neurologic complications from baseline to the end of study.	Up to 5 years
Secondary	Characterize outcomes associated with COVID-19 in children.	Duration of neurologic complications from baseline to the end of study.	Up to 5 years
Secondary	Characterize outcomes associated with COVID-19 in children.	Incidence of COVID-19 vaccination from baseline to the end of study.	Up to 5 years
Secondary	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
Secondary	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

External Links

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