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 |
|