N/A
N=4,733
Test to Stay in School: COVID-19 Testing Following Exposure in School Communities
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT05052580 ↗Enrolled (actual)
4,733
Serious AEs
—
Results posted
Nov 2023
Primary outcome: Primary: Number of Students With Positive COVID-19 Test Following Known Within-school Exposure. — 285 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- COVID-19 Testing (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Students With Positive COVID-19 Test Following Known Within-school Exposure. |
285 | — |
| PRIMARY Number of Staff With Positive COVID-19 Tests Following Known Within-school Exposure. |
38 | — |
| PRIMARY Number of Exposed Participants (as Measured by Nurse Report) Undergoing the Test-to-stay Protocol That Result in Additional Transmission. |
29 | — |
| 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. |
3.39 | — |
| SECONDARY Number of Masked Students Who Were Exposed From Masked Versus Unmasked Individuals. |
10; 5; 3146 | — |
| SECONDARY Number of Masked Staff Who Were Exposed From Masked Compared to Unmasked Individuals. |
1; 1; 354 | — |
| SECONDARY Number of Unmasked Students Who Were Exposed From Masked Compared to Unmasked Individuals. |
15; 254; 2892 | — |
| SECONDARY Number of Unmasked Staff Who Were Exposed From Masked Compared to Unmasked Individuals. |
0; 54; 302 | — |
| SECONDARY Number of Students With Positive COVID-19 Test After Indoor vs. Outdoor Exposure. |
305; 0; 2856 | — |
| SECONDARY Number of Students With Positive COVID-19 Test After Athletic vs. Classroom Exposure. |
24; 148; 2989 | — |
| SECONDARY Number of Students With Positive COVID-19 Test After Bus vs. Classroom Exposure. |
1; 148; 3012 | — |
| SECONDARY Total Number of School Days Missed Due to Symptoms After Exposure, Reported as a Mean. |
3.24737 | — |
| SECONDARY Total Number of School Days Missed Due to Isolation After Positive COVID-19 Test, Reported as a Mean. |
4.07888 | — |
| SECONDARY Total Number of School Days Missed Due to Quarantine After SARS-CoV-2 Exposure, Reported as a Mean. |
0.56593 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05052580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.