Covid19; MIS-CNCT04757831
Coronavirus-19 (COVID-19) and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
An observational study of Covid19; MIS-C, run by Duke University.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19; MIS-C
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2021to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants ≤ 21 years of age who have a COVID-19 diagnosis.
Who may be able to join
- 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:
- A positive COVID-19 test; or
- Clinical diagnosis of COVID-19 based on symptoms, as documented by a medical provider, in the absence of a positive influenza test; or
- Retrograde diagnosis based on presence of COVID-19 antibodies
Who cannot join
- N/A
About this study
Official title: A Prospective Study of COVID-19 and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
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).
- Conditions
- Covid19; MIS-C
- Medical subject headings
- COVID-19, pediatric multisystem inflammatory disease, COVID-19 related
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (13)
Describe risk factors of non-severe and severe COVID-19.
Demographic variables (e.g. English proficiency, internet access, school district, age, race)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Incidence of hospitalizations from baseline to the end of study.
Measured: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Duration of hospitalizations from baseline to the end of study.
Measured: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Incidence of neurologic complications from baseline to the end of study.
Measured: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Duration of neurologic complications from baseline to the end of study.
Measured: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Incidence of COVID-19 vaccination from baseline to the end of study.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start15 Oct 2021 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Why it stopped: Study did not begin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19; MIS-CStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanecia Zimmerman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757831
- Sponsor's protocol ID
- Pro00107647
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of COVID-19 and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
- ClinicalTrials.gov ID
- NCT04757831
- Acronym / sponsor ID
- Pro00107647
- Conditions
- Covid19; MIS-C
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not begin
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants ≤ 21 years of age who have a COVID-19 diagnosis.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
13 secondary outcomes
Describe risk factors of non-severe and severe COVID-19.
Time frame: Up to 5 years
Describe risk factors of non-severe and severe COVID-19.
Time frame: Up to 5 years
Describe risk factors of non-severe and severe COVID-19.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Characterize outcomes associated with COVID-19 in children.
Time frame: Up to 5 years
Describe characteristics of participants who attend in-person versus virtual classes.
Time frame: Up to 5 years
Describe the duration of in-person school attendance.
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- This study is a part of the ABC Science Collaborative.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
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Cardiovascular Assessment 5 Years After MIS-C
Multisystem Inflammatory Syndrome in Children (MIS-C), SARS-CoV-2 Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanecia Zimmerman, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19; MIS-C, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C). (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.