BinaxNOW for Evaluating Children for Infection With SARS-CoV-2 (COVID-19)

University of Wisconsin (UW)

Status: Terminated

Conditions: COVID-19; SARS-CoV2 Infection

Treatments: Diagnostic Test: BinaxNOW Ag Card

Study type: Interventional

Funder types: Other

Identifiers

NCT05087524

2020-1521

A536756 (Other Identifier)

philanthropic award (Other Identifier)

Protocol Version 3/4/2021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: All

Ages: 5 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

BinaxNOW Surveillance

Experimental group

Description:

Participants will agree to the performance of nasal swabs samples to be used for diagnosis or screening. Samples will be obtained by research staff in the school setting. Madison Metropolitan School District (MMSD) has obtained a Clinical Laboratory Improvement Amendments (CLIA) waiver for collection of samples. When there is a positive test, a saliva sample will be collected for testing with a standard polymerase chain reaction (PCR) method. The standard PCR samples will be processed at University of Wisconsin (UW) Clinical Laboratory.

Treatment:

Diagnostic Test: BinaxNOW Ag Card