Trial Outcomes & Findings for Safe and Healthy Schools (NCT NCT05105789)
NCT ID: NCT05105789
Last Updated: 2024-05-22
Results Overview
The primary diagnostic outcome measure will be the negative predictive value (NPV). The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the BinaxNOW at Home testing with respect to PCR nasal swab (gold standard) are reported here.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
up to 2 days
Results posted on
2024-05-22
Participant Flow
Participants were recruited from Madison Metropolitan School District from October 2021 to May 2023.
Participant milestones
| Measure |
COVID-19 Tests
If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for polymerase chain reaction (PCR) testing.
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit.
BinaxNOW Test: diagnostic test for SARS-CoV-2
"Lollipop" swab: A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.
All participants took the gold-standard Nasal Swab PCR test at school.
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|---|---|
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Overall Study
STARTED
|
100
|
|
Overall Study
Number of Participants Who Took the Nasal PCR Test at School
|
100
|
|
Overall Study
Number of Participants Who Took the Lollipop Test at School
|
100
|
|
Overall Study
Number of Participants Who Took the BinaxNow Test at School
|
100
|
|
Overall Study
Number of Participants Who Were Required to Take At-home BinaxNow Test
|
79
|
|
Overall Study
Number of Participants Who Actually Took the At-home BinaxNow Test
|
73
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
COVID-19 Tests
If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for polymerase chain reaction (PCR) testing.
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit.
BinaxNOW Test: diagnostic test for SARS-CoV-2
"Lollipop" swab: A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.
All participants took the gold-standard Nasal Swab PCR test at school.
|
|---|---|
|
Overall Study
Laboratory's lab collection device damaged
|
1
|
Baseline Characteristics
Safe and Healthy Schools
Baseline characteristics by cohort
| Measure |
COVID-19 Tests
n=100 Participants
If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for PCR testing.
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit.
BinaxNOW Test: diagnostic test for SARS-CoV-2
"Lollipop" swab: A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.
All participants took the gold-standard Nasal Swab PCR test at school.
|
|---|---|
|
Age, Categorical
<=18 years
|
64 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
55 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
43 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Prefer Not to Say
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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80 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
|
100 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 2 daysThe primary diagnostic outcome measure will be the negative predictive value (NPV). The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the BinaxNOW at Home testing with respect to PCR nasal swab (gold standard) are reported here.
Outcome measures
| Measure |
BinaxNOW At Home Testing
n=73 At-home Binax tests
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
|
Positive Nasal Swab PCR
Gold-standard Nasal Swab PCR test, only positive test results reported and compared in this column.
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|---|---|---|
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Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
Sensitivity
|
100 kappa value in percentage
Interval 44.0 to 100.0
|
—
|
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Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
Specificity
|
99 kappa value in percentage
Interval 92.0 to 100.0
|
—
|
|
Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
Positive Predictive Value
|
75 kappa value in percentage
Interval 30.0 to 99.0
|
—
|
|
Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
Negative Predictive Value
|
100 kappa value in percentage
Interval 95.0 to 100.0
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—
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PRIMARY outcome
Timeframe: up to 2 daysPopulation: 1 device did not function properly, 99 participants had data from both test to analyze
Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value.
Outcome measures
| Measure |
BinaxNOW At Home Testing
n=99 Participants
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
|
Positive Nasal Swab PCR
n=99 Participants
Gold-standard Nasal Swab PCR test, only positive test results reported and compared in this column.
|
|---|---|---|
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Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results
Lollipop PCR (Negative)
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86 COVID-19 tests
|
0 COVID-19 tests
|
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Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results
Lollipop PCR (Positive)
|
2 COVID-19 tests
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11 COVID-19 tests
|
PRIMARY outcome
Timeframe: up to 2 daysPopulation: 1 device did not function properly, 99 participants had data from both test to analyze
The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the Lollipop Swab PCR with respect to PCR nasal swab (gold standard) are reported here.
Outcome measures
| Measure |
BinaxNOW At Home Testing
n=99 COVID-19 tests
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
|
Positive Nasal Swab PCR
Gold-standard Nasal Swab PCR test, only positive test results reported and compared in this column.
|
|---|---|---|
|
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
Positive Predictive Value
|
85 kappa value in percentage
Interval 58.0 to 96.0
|
—
|
|
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
Negative Predictive Value
|
100 kappa value in percentage
Interval 96.0 to 100.0
|
—
|
|
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
Sensitivity
|
100 kappa value in percentage
Interval 74.0 to 100.0
|
—
|
|
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
Specificity
|
98 kappa value in percentage
Interval 92.0 to 99.0
|
—
|
PRIMARY outcome
Timeframe: up to 24 hoursFeasibility of 'at-home' BinaxNOW testing will be determined by number of successfully completed at-home tests. At-home test taking will be monitored by study team remotely (via zoom or similar).
Outcome measures
| Measure |
BinaxNOW At Home Testing
n=73 at home COVID-19 tests
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
|
Positive Nasal Swab PCR
Gold-standard Nasal Swab PCR test, only positive test results reported and compared in this column.
|
|---|---|---|
|
Number of Successfully Completed At-home Tests
|
73 at home COVID-19 tests
|
—
|
PRIMARY outcome
Timeframe: up to 1 dayTo address the acceptability of lollipop swabs vs nasal swabs, the study team will ask participants a binary question: Are lollipop swabs more acceptable to participants when compared to nasal swabs? Yes/No.
Outcome measures
| Measure |
BinaxNOW At Home Testing
n=100 Participants
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
|
Positive Nasal Swab PCR
Gold-standard Nasal Swab PCR test, only positive test results reported and compared in this column.
|
|---|---|---|
|
Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs
|
92 Participants
|
—
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Adverse Events
COVID-19 Tests
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ellen Wald, MD
UW School of Medicine and Public Health
Phone: (608) 263-8558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place