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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05052580

Enrollment

4733

Registered

2021-09-22

Start date

2021-10-01

Completion date

2022-03-28

Last updated

2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief 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.

Detailed 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.

Interventions

OTHERCOVID-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Measure	Time frame	Description
Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.	up to day 7 following a known COVID-19 exposure on day 0	Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—
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	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
COVID-19 Exposure Testing 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.	3,489
Total	3,489

Arm

Count

COVID-19 Exposure Testing

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.

3,489

Total

3,489

Baseline characteristics

Characteristic	—	COVID-19 Exposure Testing
Age, Continuous	— years	—
Ethnicity (NIH/OMB) Hispanic or Latino	—	383 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	3092 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	14 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	17 Participants
Race (NIH/OMB) Asian	—	66 Participants
Race (NIH/OMB) Black or African American	—	422 Participants
Race (NIH/OMB) More than one race	—	152 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	9 Participants
Race (NIH/OMB) Unknown or Not Reported	—	43 Participants
Race (NIH/OMB) White	—	2780 Participants
Region of Enrollment United States	—	3489 Participants
Sex/Gender, Customized Female	—	1870 Participants
Sex/Gender, Customized Male	—	1609 Participants
Sex/Gender, Customized Prefer not to say	—	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

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)