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Test to Stay in School: COVID-19 Testing Following Exposure in School Communities

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COVID-19 Testing
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Participating NC School Districts

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 Exposure Testing

Arm Description

Outcomes

Primary Outcome Measures

Number of students with positive COVID-19 test following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test.
Number of staff with positive COVID-19 tests following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test.
Number of exposures (as measured by nurse report) undergoing the test-to-stay protocol that result in additional transmission, reported as a proportion (%) of the total number of participants enrolled in the study.
Time (in days) to test positivity (reported as a mean) among those exposed to SARS-CoV-2 and undergoing the test-to-stay protocol.

Secondary Outcome Measures

Number of masked students with positive test who were exposed from masked versus unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Number of masked staff with positive test who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Number of unmasked students with positive tests who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Number of unmasked staff with positive tests who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Number of students with positive COVID-19 test after indoor vs. outdoor exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Number of students with positive COVID-19 test after athletic vs. classroom exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Number of students with positive COVID-19 test after bus vs. classroom exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Total number of school days missed due to symptoms after exposure, reported as a mean.
Total number of school days missed due to isolation after positive COVID-19 test, reported as a mean.
Total number of school days missed due to quarantine after SARS-CoV-2 exposure, reported as a mean.

Full Information

First Posted
September 20, 2021
Last Updated
May 2, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05052580
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4727 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 Exposure Testing
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
COVID-19 Testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of students with positive COVID-19 test following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test.
Time Frame
2 years
Title
Number of staff with positive COVID-19 tests following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test.
Time Frame
2 years
Title
Number of exposures (as measured by nurse report) undergoing the test-to-stay protocol that result in additional transmission, reported as a proportion (%) of the total number of participants enrolled in the study.
Time Frame
2 years
Title
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
2 years
Secondary Outcome Measure Information:
Title
Number of masked students with positive test who were exposed from masked versus unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Time Frame
2 years
Title
Number of masked staff with positive test who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Time Frame
2 years
Title
Number of unmasked students with positive tests who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Time Frame
2 years
Title
Number of unmasked staff with positive tests who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Time Frame
2 years
Title
Number of students with positive COVID-19 test after indoor vs. outdoor exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Time Frame
2 years
Title
Number of students with positive COVID-19 test after athletic vs. classroom exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Time Frame
2 years
Title
Number of students with positive COVID-19 test after bus vs. classroom exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test.
Time Frame
2 years
Title
Total number of school days missed due to symptoms after exposure, reported as a mean.
Time Frame
2 years
Title
Total number of school days missed due to isolation after positive COVID-19 test, reported as a mean.
Time Frame
2 years
Title
Total number of school days missed due to quarantine after SARS-CoV-2 exposure, reported as a mean.
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanecia Zimmerman, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Participating NC School Districts
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35437593
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.
Results Reference
derived

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Test to Stay in School: COVID-19 Testing Following Exposure in School Communities

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