N/A
Completed N=100
Safe and Healthy Schools
Source: ClinicalTrials.gov NCT05105789 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR — 100; 99; 75; 100 kappa value in percentage — p=0.0015
Summary
This study will target Madison Metropolitan School District (MMSD) school children ages 4-19 and staff who have not had a previous positive COVID-19 test within the past 3 months. It will enroll children and adults for 1-3 days to explore whether serial "at-home" BinaxNOW testing is feasible and non-inferior to "at school" single PCR testing for the evaluation of symptomatic individuals with a negative initial BinaxNOW. It will also explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with polymerase chain reaction (PCR) testing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR |
100; 99; 75; 100 | 0.0015 sig |
| PRIMARY Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results |
86; 0; 2; 11 | — |
| PRIMARY Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR |
100; 98; 85; 100 | 0.2010 |
| PRIMARY Number of Successfully Completed At-home Tests |
73 | — |
| PRIMARY Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs |
92 | — |
Eligibility Criteria
Inclusion Criteria
- school children ages 4-19
- MMSD staff
- have at least one symptom of COVID-19
- have not had a positive COVID-19 test in the past 3 months
- will undergo nasal PCR testing at an MMSD elementary school
Exclusion Criteria
- received a positive COVID-19 test in the past 3 months
Criteria for inclusion in the final study sample:
- Aim 1. Symptomatic participants with a negative at-school BinaxNOW test and nasal PCR results who complete both the lollipop PCR and at-home BinaxNOW tests within 72 hours will be included in the final study sample.
- Aim 2. Symptomatic participants who provide a lollipop swab that is successfully resulted.
Criteria for exclusion in the final study sample:
- Aim 1
- Missing nasal PCR result
- Do not successfully complete an at-home BinaxNOW test within 72 hours of the at-school BinaxNOW test
- Aim 2
- Missing nasal PCR result
- Missing lollipop PCR result
Data sourced from ClinicalTrials.gov (NCT05105789). 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. Informational only — not medical advice.