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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).
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| 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 |
| 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. |
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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:
Exclusion Criteria:
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Participants ≤ 21 years of age who have a COVID-19 diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Kanecia Zimmerman, MD | Duke University | Principal Investigator |
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| Label | URL |
|---|---|
| This study is a part of the ABC Science Collaborative. | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| C000705967 | pediatric multisystem inflammatory disease, COVID-19 related |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |