Safe and Healthy Schools
Completed · Not applicable
Conditions studied: Sars-CoV-2 Infection, COVID-19
In brief
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.
Key facts
- Study ID
- NCT05105789
- Run by
- University of Wisconsin, Madison
- People needed
- 100
- Starts
- 2021-10-11
- Expected to finish
- 2023-05-21
- Last updated by the study team
- 2024-05-22
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Community Locations — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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