Clinical trial NCT05087524: BinaxNOW for Evaluating Children for Infection With SARS-CoV-2 (COVID-19)
Official title: Feasibility and Specificity of BinaxNOW for Diagnosis and Surveillance of Infection With SARS-CoV-2 in Schoolchildren
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: SARS-CoV2 Infection
COVID-19
Keywords: diagnostic
diagnosis
schools
BinaxNOW
surveillance
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 65
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study of the BinaxNOW Covid-19 Ag Card as a method to rapidly identify SARS-CoV-2 infection in asymptomatic children, teachers, and other school staff for exclusion. 240 students and 80 teachers in the Madison Metropolitan School District (MMSD) will be enrolled and can expect to be on study for up to 8 weeks.

Detailed description: The overall purpose and research goal of this project is to understand how the virus SARS-CoV-2 is spread in the K-8 setting, decrease secondary cases of COVID-19, improve attendance and educational opportunities for children, teachers and other school staff, and decrease time away from work for parents (with threat of loss of employment and other benefits).

The investigators hypothesize that prompt diagnostic testing for SARS-CoV-2 in symptomatic children and twice weekly surveillance of asymptomatic children (with appropriate exclusion of children with positive tests) will be effective as a strategy to achieve maximum attendance in school and minimal disruption of the associated workforce.

STEP 1: Determine feasibility of using BinaxNOW COVID-19 cards for surveillance of infection with SARS-CoV-2 in teachers, other school staff, and school children.

The specific aims are to determine:

* if it is feasible to obtain nasal samples to be used with the BinaxNOW COVID-19 for diagnosis of COVID-19 in children or teachers/other school staff.
* if it is feasible to obtain nasal samples twice weekly to be used with BinaxNOW COVID-19 for surveillance of infection with SARS-CoV-2.
* The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing.

STEP 2: Determine effectiveness of prompt diagnostic testing and twice weekly surveillance for SARS-CoV-2 among children and school faculty/staff to reduce the rate of positive cases (symptomatic) of COVID-19 in an elementary school setting resulting in an ultimate decrease in absenteeism for students and an increase in attendance for their parents at the workplace.

This is a record of the pilot study (STEP 1).

Eligibility criteria: Inclusion Criteria:

* Children aged 5 - 15 years inclusive
* Currently attending school K-8 at one of the designated schools of the Madison Metropolitan School District
* Teachers and other school staff aged 20-65 years

Exclusion Criteria:

* Children \< 5 years or \> 16 years
* Teachers and other school staff \< 20 years or \> 65 years

Primary outcomes:
measure: Number of Tests Taken Per Participant
timeFrame: up to 8 weeks
measure: Number of Positive SARS-CoV-2 BinaxNOW Tests Confirmed by PCR Testing
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References: