COVID-19 Surveillance and Exposure Testing in School Communities

NCT ID: NCT04831866

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-26

Study Completion Date

2022-01-31

Brief Summary

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This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.

Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.

Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Surveillance Cohort

Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.

No interventions assigned to this group

Exposure Cohort

Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kanecia Zimmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Durham Charter Schools

Durham, North Carolina, United States

Site Status

Iredell-Statesville Schools

Statesville, North Carolina, United States

Site Status

Countries

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United States

References

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Kalu IC, Zimmerman KO, Goldman JL, Keener Mast D, Blakemore AM, Moorthy G, Boutzoukas AE, Campbell MM, Uthappa D, DeLaRosa J, Potts JM, Edwards LJ, Selvarangan R, Benjamin DK, Mann TK, Schuster JE. SARS-CoV-2 Screening Testing Programs for Safe In-person Learning in K-12 Schools. J Pediatric Infect Dis Soc. 2023 Feb 27;12(2):64-72. doi: 10.1093/jpids/piac119.

Reference Type DERIVED
PMID: 36412278 (View on PubMed)

Other Identifiers

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Pro00108049

Identifier Type: -

Identifier Source: org_study_id

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