Covid19NCT05052580
Test to Stay in School: COVID-19 Testing Following Exposure in School Communities
A study testing COVID-19 Testing in people with Covid19, run by Duke University at 1 site in United States.
Trial summary
Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,733 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 28 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consent completed
- Child or adult that is part of a school community
- Known exposure to SARS-CoV-2 in the school setting (e.g. school bus, classroom, school sporting event, etc.)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Participating NC School Districts
Durham, North Carolina, 27707
About this study
Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Mitigation practices including masking, the context of exposure (classroom, school bus, after school sporting event, lunch, etc.), and results of COVID-19 test will be documented.
Read the detailed description
This is a prospective, interventional study with a primary objective of evaluating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission following exposure in Kindergarten through 12th grade schools. Participants will be tested with a COVID-19 testing kit that is Food and Drug Administration (FDA)-authorized under an emergency use authorization (EUA) for non-prescription use for both symptomatic and asymptomatic evaluation in children and adults. Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If a participant does not know of the exposure until more than one day following they exposure, they will be tested on the day they become aware of the exposure and then resume the aforementioned testing schedule (e.g. participant identifies exposure 3 days after the exposure, test on day 3, day 5, and day 7).
If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines. Demographic information, daily presence or absence of symptoms, whether the infected person or close contact was masked, setting of the exposure, test results, and school absences will be collected following consent. Data regarding school level mitigation practices will also be collected. Data collected from this study may be combined with school-provided data and publically available community data.
- Conditions
- Covid19
- Being tested
- COVID-19 Testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 TestingOther
Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Exposure Testing | Other | Not described Receives: Other: COVID-19 Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Students With Positive COVID-19 Test Following Known Within-school Exposure.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Exposed Participants (as Measured by Nurse Report) Undergoing the Test-to-stay Protocol That Result in Additional Transmission.
Exposures That Result in Additional Transmission (TAR = # of positives in TTS close contacts, out of all TTS close contacts)
Measured: up to day 7 following a known COVID-19 exposure on day 0
Time (in Days) to Test Positivity (Reported as a Mean) Among Those Exposed to SARS-CoV-2 and Undergoing the Test-to-stay Protocol.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Secondary outcomes (10)
Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.
Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean.
Measured: up to day 7 following a known COVID-19 exposure on day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Oct 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,733 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanecia Zimmerman, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052580
- Sponsor's protocol ID
- Pro00109436
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 2021
- Last updated
- 27 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campbell MM, Benjamin DK, Mann T, Fist A, Kim H, Edwards L, Rak Z, Brookhart MA, Anstrom K, Moore Z, Tilson EC, Kalu IC, Boutzoukas AE, Moorthy GS, Uthappa D, Scott Z, Weber DJ, Shane AL, Bryant KA, Zimmerman KO; ABC SCIENCE COLLABORATIVE. Test-to-Stay After Exposure to SARS-CoV-2 in K-12 Schools. Pediatrics. 2022 May 1;149(5):e2021056045. doi: 10.1542/peds.2021-056045.
PubMed 35437593
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test to Stay in School: COVID-19 Testing Following Exposure in School Communities
- ClinicalTrials.gov ID
- NCT05052580
- Acronym / sponsor ID
- Pro00109436
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,733 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Posted 27 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Mitigation practices including masking, the context of exposure (classroom, school bus, after school sporting event, lunch, etc.), and results of COVID-19 test will be documented.
Detailed description
This is a prospective, interventional study with a primary objective of evaluating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission following exposure in Kindergarten through 12th grade schools. Participants will be tested with a COVID-19 testing kit that is Food and Drug Administration (FDA)-authorized under an emergency use authorization (EUA) for non-prescription use for both symptomatic and asymptomatic evaluation in children and adults. Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If a participant does not know of the exposure until more than one day following they exposure, they will be tested on the day they become aware of the exposure and then resume the aforementioned testing schedule (e.g. participant identifies exposure 3 days after the exposure, test on day 3, day 5, and day 7).
If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines. Demographic information, daily presence or absence of symptoms, whether the infected person or close contact was masked, setting of the exposure, test results, and school absences will be collected following consent. Data regarding school level mitigation practices will also be collected. Data collected from this study may be combined with school-provided data and publically available community data.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Exposure Testing | Other | Other: COVID-19 Testing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Consent completed
- Child or adult that is part of a school community
- Known exposure to SARS-CoV-2 in the school setting (e.g. school bus, classroom, school sporting event, etc.)
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 TestingParticipants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines. | Other | COVID-19 Exposure Testing |
Primary outcome
Number of Students With Positive COVID-19 Test Following Known Within-school Exposure.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Exposed Participants (as Measured by Nurse Report) Undergoing the Test-to-stay Protocol That Result in Additional Transmission.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Exposures That Result in Additional Transmission (TAR = # of positives in TTS close contacts, out of all TTS close contacts)
Time (in Days) to Test Positivity (Reported as a Mean) Among Those Exposed to SARS-CoV-2 and Undergoing the Test-to-stay Protocol.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
10 secondary outcomes
Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean.
Time frame: up to day 7 following a known COVID-19 exposure on day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35437593Campbell MM, Benjamin DK, Mann T, Fist A, Kim H, Edwards L, Rak Z, Brookhart MA, Anstrom K, Moore Z, Tilson EC, Kalu IC, Boutzoukas AE, Moorthy GS, Uthappa D, Scott Z, Weber DJ, Shane AL, Bryant KA, Zimmerman KO; ABC SCIENCE COLLABORATIVE. Test-to-Stay After Exposure to SARS-CoV-2 in K-12 Schools. Pediatrics. 2022 May 1;149(5):e2021056045. doi: 10.1542/peds.2021-056045.
- 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, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Testing in people with Covid19, run by Duke University at 1 site 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 3 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 27 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Students With Positive COVID-19 Test Following Known Within-school Exposure. (time frame: up to day 7 following a known COVID-19 exposure on day 0). 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 NCT05052580, 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 27 Nov 2023.