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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Exposure Testing | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Testing | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Students With Positive COVID-19 Test Following Known Within-school Exposure. | 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. | 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) | 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. | up to day 7 following a known COVID-19 exposure on day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals. | 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. | up to day 7 following a known COVID-19 exposure on day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kanecia Zimmerman, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Participating NC School Districts | Durham | North Carolina | 27707 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35437593 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Exposure Testing | COVID-19 Testing: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who tested positive or had a negative follow-up test at day 5 or later, and completed follow-up among those enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Exposure Testing | COVID-19 Testing: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not collected as part of this study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Students With Positive COVID-19 Test Following Known Within-school Exposure. | Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
Adverse Events data not collected.
Adverse Events data not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID-19 Exposure Testing | COVID-19 Testing: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara Mann, PhD, RN | Duke Clinical Research Institute | (919) 668-5111 | schoolSETstudy@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2021 | Oct 12, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2022 | Oct 12, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2021 | May 2, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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|
| Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | up to day 7 following a known COVID-19 exposure on day 0 |
| Mean |
| Full Range |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure. | Staff participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Primary | 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) | Exposed participants (as measured by nurse report) undergoing the test-to-stay protocol. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Primary | Time (in Days) to Test Positivity (Reported as a Mean) Among Those Exposed to SARS-CoV-2 and Undergoing the Test-to-stay Protocol. | Positive student and staff participants. | Posted | Mean | Full Range | Days | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals. | Masked student participants. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals. | Masked staff participants. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals. | Unmasked student participants. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals. | Unmasked staff participants. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure. | Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure | Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure. | Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure. | Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up. | Posted | Count of Participants | Participants | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean. | Participants who missed school days due to symptoms after exposure. | Posted | Mean | Full Range | Days | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean. | Student participants who missed school days due to isolation after positive COVID-19 test. | Posted | Mean | Full Range | Days | up to day 7 following a known COVID-19 exposure on day 0 |
|
|
|
| Secondary | Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean. | Participants who missed school days due to quarantine after SARS-CoV-2 exposure. | Posted | Mean | Full Range | Days | up to day 7 following a known COVID-19 exposure on day 0 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |