Clinical trial NCT05052580: Test to Stay in School: COVID-19 Testing Following Exposure in School Communities
Official title: Test to Stay in School: COVID-19 Testing Following Exposure in School Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 4733
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Students With Positive COVID-19 Test Following Known Within-school Exposure.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Exposed Participants (as Measured by Nurse Report) Undergoing the Test-to-stay Protocol That Result in Additional Transmission.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Time (in Days) to Test Positivity (Reported as a Mean) Among Those Exposed to SARS-CoV-2 and Undergoing the Test-to-stay Protocol.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
Secondary outcomes:
measure: Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
measure: Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean.
timeFrame: up to day 7 following a known COVID-19 exposure on day 0
Other outcomes:
Locations:
city: Durham
country: United States
facility: Participating NC School Districts
state: North Carolina
Study officials:
affiliation: Duke University
name: Kanecia Zimmerman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.