Covid19; MIS-C
Conditions
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).
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Demographic variables (e.g. English proficiency, internet access, school district, age, race) |
| Characterize outcomes associated with COVID-19 in children. | Up to 5 years | Incidence of subsequent exposures to COVID-19 from baseline to the end of study. |
| 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. |
Outcome results
None listed