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

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Duke University

Status

Completed

Conditions

Covid19

Treatments

Other: COVID-19 Testing

Study type

Interventional

Funder types

Other

Identifiers

NCT05052580
Pro00109436

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,733 patients

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4,733 participants in 1 patient group

COVID-19 Exposure Testing
Other group
Treatment:
Other: COVID-19 Testing

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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