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OpenTrials
Completed

NCT Number: NCT05052580

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Participating NC School Districts

Durham, North Carolina, 27707, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 Testing

Other

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.

Primary outcomes

  1. Number of Students With Positive COVID-19 Test Following Known Within-school Exposure.

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

  2. Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure.

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

  3. Number of Exposed Participants (as Measured by Nurse Report) Undergoing the Test-to-stay Protocol That Result in Additional Transmission.

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

    Exposures That Result in Additional Transmission (TAR = # of positives in TTS close contacts, out of all TTS close contacts)

  4. Time (in Days) to Test Positivity (Reported as a Mean) Among Those Exposed to SARS-CoV-2 and Undergoing the Test-to-stay Protocol.

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

Secondary outcomes

  1. Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.

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

  2. Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.

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

  3. Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.

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

  4. Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.

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

  5. Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.

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

    Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure

  6. Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.

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

  7. Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.

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

  8. Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean.

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

  9. Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean.

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

  10. Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean.

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2021
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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