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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 3/4/2021 | Other Identifier | UW Madison | |
| A536756 | Other Identifier | UW Madison | |
| philanthropic award | Other Identifier | American Family Children's Hospital |
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changes in in-person schooling per COVID-19 pandemic
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen R Wald, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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Madison Metropolitan School District (MMSD) Student and Staff Participants were enrolled from January to April 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | BinaxNOW Surveillance | 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. 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. BinaxNOW Ag Card: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | BinaxNOW Surveillance | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | tests taken | up to 8 weeks |
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Adverse Events were not collected.
Adverse events data collection was not part of this protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BinaxNOW Surveillance | 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. |
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This study was terminated early due to changes in in-person schooling per COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Wald | University of Wisconsin - Madison | (608) 263-8558 | erwald@pediatrics.wisc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2021 | Jan 25, 2022 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Participants |
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| Sex: Female, Male | Gender of participants not collected. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Number | positive tests | up to 5 weeks |
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| 0 |
| 0 |
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| 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |