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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052580
• Other study ID #: Pro00109436
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 28, 2022

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4733
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• COVID-19 Testing
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.

Locations

Country	Name	City	State
United States	Participating NC School Districts	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.	Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure	up to day 7 following a known COVID-19 exposure on day 0
Secondary	Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.		up to day 7 following a known COVID-19 exposure on day 0
Secondary	Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.		up to day 7 following a known COVID-19 exposure on day 0
Secondary	Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean.		up to day 7 following a known COVID-19 exposure on day 0
Secondary	Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean.		up to day 7 following a known COVID-19 exposure on day 0
Secondary	Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean.		up to day 7 following a known COVID-19 exposure on day 0