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 Type
OBSERVATIONAL
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.
Time frame: 90 days
Describe risk factors of non-severe and severe COVID-19.
Demographic variables (e.g. English proficiency, internet access, school district, age, race)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
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Duration of ongoing COVID-19 symptoms from baseline to the end of study.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Incidence of hospitalizations from baseline to the end of study.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Duration of hospitalizations from baseline to the end of study.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Incidence of neurologic complications from baseline to the end of study.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Duration of neurologic complications from baseline to the end of study.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Incidence of COVID-19 vaccination from baseline to the end of study.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years