COVID19NCT04781218
ABC Science Collaborative Registry Study
An observational study of COVID19, run by Duke University.
Trial summary
The ABC Registry is associated with Pro00107943 and provides a resource for collecting information on members of school communities both regionally in North and South Carolina, as well as nationally in the United States (U.S.) through the National Program, including children, parents, teachers, superintendents, and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID19
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2021to 15 Mar 2026
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: School community members, including students, parents, staff, etc.
Who may be able to join
- Participant currently attends, is the parent of a student, works in, or works with a school that is participating in the ABC Science Collaborative, or participant is an adult or child who learned of the registry through clinical practice and is interested in participating in COVID-19 related research,
- Participant or their parent/guardian has provided informed consent or assent, as applicable
- Participant or their parent/guardian has downloaded the "ABC Science" App from the App store as a part of the ABC Science Collaborative and has agreed to the App's Terms of Use
- Participant or their parent/guardian is able to speak and read English or Spanish
Who cannot join
- There are no specific exclusion criteria for this registry. Participants must meet inclusion criteria.
About this study
The ABC Registry is associated with Pro00107943 and provides a resource for collecting information on members of school communities both regionally in North and South Carolina, as well as nationally in the United States (U.S.) through the National Program, including children, parents, teachers, superintendents, and other staff; and children identified through clinical practice. The overall goals of the Registry are to collect data relevant to public health during the coronavirus 2019 (COVID-19) pandemic and to establish and engage school communities that may be eligible for participation in future research studies, including observational studies, as well as prospective COVID-19 trials.
- Conditions
- COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants enrolled in the registry | Participants enrolled in the registry will include school community members including students, parents, staff, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants who enroll in the ABC Registry
Number of participants who enroll in the ABC Registry (e.g. are interested in participating in upcoming research studies, including those related to COVID-19).
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 posted4 Mar 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Why it stopped: Study did not start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
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
- NCT04781218
- Sponsor's protocol ID
- Pro00107036
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 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
- ABC Science Collaborative Registry Study
- ClinicalTrials.gov ID
- NCT04781218
- Acronym / sponsor ID
- Pro00107036
- Conditions
- COVID19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 4 Mar 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.
The ABC Registry is associated with Pro00107943 and provides a resource for collecting information on members of school communities both regionally in North and South Carolina, as well as nationally in the United States (U.S.) through the National Program, including children, parents, teachers, superintendents, and other staff; and children identified through clinical practice. The overall goals of the Registry are to collect data relevant to public health during the coronavirus 2019 (COVID-19) pandemic and to establish and engage school communities that may be eligible for participation in future research studies, including observational studies, as well as prospective COVID-19 trials.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants enrolled in the registry | – | –Participants enrolled in the registry will include school community members including students, parents, staff, etc. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- School community members, including students, parents, staff, etc.
Key inclusion criteria (4 listed)
- Participant currently attends, is the parent of a student, works in, or works with a school that is participating in the ABC Science Collaborative, or participant is an adult or child who learned of the registry through clinical practice and is interested in participating in COVID-19 related research,
- Participant or their parent/guardian has provided informed consent or assent, as applicable
- Participant or their parent/guardian has downloaded the "ABC Science" App from the App store as a part of the ABC Science Collaborative and has agreed to the App's Terms of Use
- Participant or their parent/guardian is able to speak and read English or Spanish
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this registry. Participants must meet inclusion criteria.
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
Participants who enroll in the ABC Registry
Time frame: Up to 5 years
Number of participants who enroll in the ABC Registry (e.g. are interested in participating in upcoming research studies, including those related to COVID-19).
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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, 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 4 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?
Participants who enroll in the ABC Registry (time frame: Up to 5 years). 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.