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

NCT05087524 | Terminated Results FDA Device

• 4 other identifiers: 2020-1521Protocol Version 3/4/2021A536756philanthropic award
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection; COVID-19

Keywords

diagnostic; diagnosis; schools; BinaxNOW; surveillance

Outcome Measures

Primary Outcomes (2)

• Number of Tests Taken Per Participant

  Feasibility BinaxNOW surveillance testing will be measured by the number of test taken per participant. Greater than 1 test per participant is an indicator of compliance with repeat surveillance testing.

  up to 8 weeks

• Number of Positive SARS-CoV-2 BinaxNOW Tests Confirmed by PCR Testing

  The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing.

  up to 5 weeks

Study Arms (1)

BinaxNOW Surveillance

EXPERIMENTAL

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.

Diagnostic Test: BinaxNOW Ag Card

Interventions

BinaxNOW Ag Card DIAGNOSTIC_TEST

A nasal swab specimen is collected from the participant, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The participant sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines.

BinaxNOW Surveillance

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated early due to changes in in-person schooling per COVID-19 pandemic.

Results Point of Contact

• Title: Dr. Ellen Wald
• Organization: University of Wisconsin - Madison

erwald@pediatrics.wisc.edu

(608) 263-8558

Study Officials

• Ellen R Wald, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 21, 2021
• Study Start: January 9, 2021
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: January 28, 2022
• Results First Posted: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)