COVID-19 Surveillance and Exposure Testing in School Communities

Completed

• Conditions: Covid19

• Registration Number: NCT04831866
• Lead Sponsor: Duke University

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Study Start: 2021-04-26
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.	2 years	Mean time to return-to-school after SARS-CoV-2 exposure in the month after initiation of the school-provided testing program compared to the month prior to initiation of the school-provided testing program.
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.	2 years	Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure.
Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.	2 years	Proportion of students who return to in-person education in Fall 2021, Spring 2022, and Fall 2022 from participating schools conducting surveillance testing compared to districts without testing.
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort.	2 years	Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing.

Trial Locations

Locations (2)

Durham Charter Schools; 🇺🇸 Durham, North Carolina, United States

Iredell-Statesville Schools; 🇺🇸 Statesville, North Carolina, United States