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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: COVID-19 Testing

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 Type: Interventional
• Enrollment (Actual): 4733
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Participating NC School Districts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: COVID-19 Exposure Testing

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kanecia Zimmerman, MD, MPH, Duke University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00109436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No