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

Study Overview
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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).

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

Conditions
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Covid19; MIS-C

Participation Criteria
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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: A positive COVID-19 test; or Clinical diagnosis of COVID-19 based on symptoms, as documented by a medical provider, in the absence of a positive influenza test; or Retrograde diagnosis based on presence of COVID-19 antibodies Exclusion Criteria: N/A

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |