Clinical trial NCT04757831: Coronavirus-19 (COVID-19) and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
Official title: A Prospective Study of COVID-19 and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid19; MIS-C
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 0
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants ≤ 21 years of age who have a COVID-19 diagnosis.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C).
timeFrame: 90 days
Secondary outcomes:
measure: Describe risk factors of non-severe and severe COVID-19.
timeFrame: Up to 5 years
measure: Describe risk factors of non-severe and severe COVID-19.
timeFrame: Up to 5 years
measure: Describe risk factors of non-severe and severe COVID-19.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Characterize outcomes associated with COVID-19 in children.
timeFrame: Up to 5 years
measure: Describe characteristics of participants who attend in-person versus virtual classes.
timeFrame: Up to 5 years
measure: Describe the duration of in-person school attendance.
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Kanecia Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References: