Coronavirus-19 (COVID-19) and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)

• ClinicalTrials.gov Identifier: NCT04757831
• Recruitment Status: Withdrawn
• First Posted: February 17, 2021
• Last Update Posted: September 16, 2021
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

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).

Condition or disease
Covid19; MIS-C

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study of COVID-19 and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
• Estimated Study Start Date: October 15, 2021
• Estimated Primary Completion Date: February 15, 2026
• Estimated Study Completion Date: February 15, 2026

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C). [ Time Frame: 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 Outcome Measures :

1. Describe risk factors of non-severe and severe COVID-19. [ Time Frame: Up to 5 years ]
   Demographic variables (e.g. English proficiency, internet access, school district, age, race)
2. Describe risk factors of non-severe and severe COVID-19. [ Time Frame: Up to 5 years ]
   COVID-19-related symptoms (e.g. cough, fever, shortness of breath, headache, loss of smell)
3. Describe risk factors of non-severe and severe COVID-19. [ Time Frame: Up to 5 years ]
   Type of COVID-19 exposure (e.g. household, school-related, travel, other, unknown)
4. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
   Incidence of subsequent exposures to COVID-19 from baseline to the end of study.
5. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
   Incidence of ongoing COVID-19 symptoms from baseline to the end of study.
6. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
   Duration of ongoing COVID-19 symptoms from baseline to the end of study.
7. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
   Incidence of hospitalizations from baseline to the end of study.
8. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
   Duration of hospitalizations from baseline to the end of study.
9. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
   Incidence of neurologic complications from baseline to the end of study.
10. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Duration of neurologic complications from baseline to the end of study.
11. Characterize outcomes associated with COVID-19 in children. [ Time Frame: Up to 5 years ]
    Incidence of COVID-19 vaccination from baseline to the end of study.
12. Describe characteristics of participants who attend in-person versus virtual classes. [ Time Frame: Up to 5 years ]
    Baseline demographics of those who attend in-person classes compared to those who do not.
13. Describe the duration of in-person school attendance. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: up to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Participants ≤ 21 years of age who have a COVID-19 diagnosis.

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

Contacts and Locations

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Kanecia Zimmerman, MD; Duke University

More Information

Additional Information:

This study is a part of the ABC Science Collaborative. 

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04757831
• Other Study ID Numbers: Pro00107647
• First Posted: February 17, 2021
• Last Update Posted: September 16, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases