NCT05052580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,733

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 27, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

September 20, 2021

Results QC Date

January 9, 2023

Last Update Submit

November 3, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • 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.

    up to day 7 following a known COVID-19 exposure on day 0

  • +5 more secondary outcomes

Study Arms (1)

COVID-19 Exposure Testing

OTHER
Other: COVID-19 Testing

Interventions

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.

COVID-19 Exposure Testing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Participating NC School Districts

Durham, North Carolina, 27707, United States

Location

Related Publications (1)

  • 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.

    PMID: 35437593DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Testing

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Results Point of Contact

Title
Tara Mann, PhD, RN
Organization
Duke Clinical Research Institute
schoolSETstudy@duke.edu
(919) 668-5111

Study Officials

  • Kanecia Zimmerman, MD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 22, 2021

Study Start

October 1, 2021

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

November 27, 2023

Results First Posted

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)