Trial Outcomes & Findings for Test to Stay in School: COVID-19 Testing Following Exposure in School Communities (NCT NCT05052580)
NCT ID: NCT05052580
Last Updated: 2023-11-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4733 participants
Primary outcome timeframe
up to day 7 following a known COVID-19 exposure on day 0
Results posted on
2023-11-27
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
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4733
|
|
Overall Study
COMPLETED
|
3489
|
|
Overall Study
NOT COMPLETED
|
1244
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was not collected as part of this study.
Baseline characteristics by cohort
| Measure |
COVID-19 Exposure Testing
n=3489 Participants
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.
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|---|---|
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Sex/Gender, Customized
Female
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1870 Participants
n=3489 Participants
|
|
Sex/Gender, Customized
Male
|
1609 Participants
n=3489 Participants
|
|
Sex/Gender, Customized
Prefer not to say
|
10 Participants
n=3489 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
383 Participants
n=3489 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3092 Participants
n=3489 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=3489 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
17 Participants
n=3489 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=3489 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=3489 Participants
|
|
Race (NIH/OMB)
Black or African American
|
422 Participants
n=3489 Participants
|
|
Race (NIH/OMB)
White
|
2780 Participants
n=3489 Participants
|
|
Race (NIH/OMB)
More than one race
|
152 Participants
n=3489 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=3489 Participants
|
|
Region of Enrollment
United States
|
3489 Participants
n=3489 Participants
|
PRIMARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=3002 Participants
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.
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|---|---|
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Number of Students With Positive COVID-19 Test Following Known Within-school Exposure.
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285 Participants
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PRIMARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Staff participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=250 Participants
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.
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|---|---|
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Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure.
|
38 Participants
|
PRIMARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Exposed participants (as measured by nurse report) undergoing the test-to-stay protocol.
Exposures That Result in Additional Transmission (TAR = # of positives in TTS close contacts, out of all TTS close contacts)
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=409 Participants
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.
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|---|---|
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Number of Exposed Participants (as Measured by Nurse Report) Undergoing the Test-to-stay Protocol That Result in Additional Transmission.
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29 Participants
|
PRIMARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Positive student and staff participants.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=323 Participants
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.
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|---|---|
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Time (in Days) to Test Positivity (Reported as a Mean) Among Those Exposed to SARS-CoV-2 and Undergoing the Test-to-stay Protocol.
|
3.39 Days
Interval 0.0 to 10.0
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SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Masked student participants.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=3161 Participants
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.
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|---|---|
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Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.
COVID-19 Positive - Masked
|
10 Participants
|
|
Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.
COVID-19 Positive - Unmasked
|
5 Participants
|
|
Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals.
COVID-19 Negative
|
3146 Participants
|
SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Masked staff participants.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=356 Participants
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.
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|---|---|
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Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Positive - Masked
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1 Participants
|
|
Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Positive - Unmasked
|
1 Participants
|
|
Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Negative
|
354 Participants
|
SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Unmasked student participants.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=3161 Participants
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.
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|---|---|
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Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Positive - Masked
|
15 Participants
|
|
Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Positive - Unmasked
|
254 Participants
|
|
Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Negative
|
2892 Participants
|
SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Unmasked staff participants.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=356 Participants
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.
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|---|---|
|
Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Positive - Masked
|
0 Participants
|
|
Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Positive - Unmasked
|
54 Participants
|
|
Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals.
COVID-19 Negative
|
302 Participants
|
SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up.
Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=3161 Participants
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.
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|---|---|
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Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.
COVID-19 Positive - Indoor
|
305 Participants
|
|
Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.
COVID-19 Positive - Outdoor
|
0 Participants
|
|
Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure.
COVID-19 Negative
|
2856 Participants
|
SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=3161 Participants
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.
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|---|---|
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Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.
COVID-19 Positive - Athletic Exposure
|
24 Participants
|
|
Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.
COVID-19 Positive - Classroom Exposure
|
148 Participants
|
|
Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure.
COVID-19 Negative
|
2989 Participants
|
SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Student participants who were tested positive or had a negative follow-up test at day 5 or later, and completed follow-up.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=3161 Participants
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.
|
|---|---|
|
Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.
COVID-19 Negative
|
3012 Participants
|
|
Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.
COVID-19 Positive - Bus Exposure
|
1 Participants
|
|
Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure.
COVID-19 Positive - Classroom Exposure
|
148 Participants
|
SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Participants who missed school days due to symptoms after exposure.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=192 Participants
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.
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|---|---|
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Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean.
|
3.24737 Days
Interval 0.0 to 12.0
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SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Student participants who missed school days due to isolation after positive COVID-19 test.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=396 Participants
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.
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|---|---|
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Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean.
|
4.07888 Days
Interval 0.0 to 11.0
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SECONDARY outcome
Timeframe: up to day 7 following a known COVID-19 exposure on day 0Population: Participants who missed school days due to quarantine after SARS-CoV-2 exposure.
Outcome measures
| Measure |
COVID-19 Exposure Testing
n=3036 Participants
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.
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|---|---|
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Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean.
|
0.56593 Days
Interval 0.0 to 7.0
|
Adverse Events
COVID-19 Exposure Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place