Covid19NCT04831866
COVID-19 Surveillance and Exposure Testing in School Communities
An observational study of Covid19, run by Duke University at 2 sites in United States.
Trial summary
This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 4,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Apr 2021to 31 Jan 2022
- 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
- Child, Adult, Older adult
Study population: All students and staff who are members of participating school communities will be given the opportunity to consent to this study. Both children and adult school community members will be included in this study.
Who may be able to join
- Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Durham Charter Schools
Durham, North Carolina, 27710
Iredell-Statesville Schools
Statesville, North Carolina, 28677
About this study
Official title: Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities
This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.
Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.
Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.
- 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 |
|---|---|---|
| Surveillance Cohort | Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff. | |
| Exposure Cohort | Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort.
Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing.
Measured: 2 years
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.
Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure.
Measured: 2 years
Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.
Proportion of students who return to in-person education in Fall 2021, Spring 2022, and Fall 2022 from participating schools conducting surveillance testing compared to districts without testing.
Measured: 2 years
Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.
Mean time to return-to-school after SARS-CoV-2 exposure in the month after initiation of the school-provided testing program compared to the month prior to initiation of the school-provided testing program.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start26 Apr 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 4,000 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
- NCT04831866
- Sponsor's protocol ID
- Pro00108049
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalu IC, Zimmerman KO, Goldman JL, Keener Mast D, Blakemore AM, Moorthy G, Boutzoukas AE, Campbell MM, Uthappa D, DeLaRosa J, Potts JM, Edwards LJ, Selvarangan R, Benjamin DK, Mann TK, Schuster JE. SARS-CoV-2 Screening Testing Programs for Safe In-person Learning in K-12 Schools. J Pediatric Infect Dis Soc. 2023 Feb 27;12(2):64-72. doi: 10.1093/jpids/piac119.
PubMed 36412278
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities
- ClinicalTrials.gov ID
- NCT04831866
- Acronym / sponsor ID
- Pro00108049
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 5 Apr 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 of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.
Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.
Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance Cohort | – | –Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff. |
| Exposure Cohort | – | –Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All students and staff who are members of participating school communities will be given the opportunity to consent to this study. Both children and adult school community members will be included in this study.
Key inclusion criteria (1 listed)
- Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).
Key exclusion criteria (1 listed)
- None
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
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort.
Time frame: 2 years
Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing.
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.
Time frame: 2 years
Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure.
Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.
Time frame: 2 years
Proportion of students who return to in-person education in Fall 2021, Spring 2022, and Fall 2022 from participating schools conducting surveillance testing compared to districts without testing.
Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.
Time frame: 2 years
Mean time to return-to-school after SARS-CoV-2 exposure in the month after initiation of the school-provided testing program compared to the month prior to initiation of the school-provided testing program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 36412278Kalu IC, Zimmerman KO, Goldman JL, Keener Mast D, Blakemore AM, Moorthy G, Boutzoukas AE, Campbell MM, Uthappa D, DeLaRosa J, Potts JM, Edwards LJ, Selvarangan R, Benjamin DK, Mann TK, Schuster JE. SARS-CoV-2 Screening Testing Programs for Safe In-person Learning in K-12 Schools. J Pediatric Infect Dis Soc. 2023 Feb 27;12(2):64-72. doi: 10.1093/jpids/piac119.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Duke University at 2 sites in United States.
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 1 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: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort. (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831866, which also lists 1 linked publication.
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 13 Apr 2022.