Sars-CoV-2 InfectionNCT05105789

Safe and Healthy Schools

A study testing BinaxNOW Test and "Lollipop" swab in people with Sars-CoV-2 Infection and COVID-19, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 years and olderHealthy volunteers can take part
Conditions the study is for: Sars-CoV-2 Infection, COVID-19
What is being tested?: BinaxNOW Test and "Lollipop" swab
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 11 Oct 2021to 21 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

school children ages 4-19
MMSD staff
have at least one symptom of COVID-19
have not had a positive COVID-19 test in the past 3 months
will undergo nasal PCR testing at an MMSD elementary school

Who cannot join

received a positive COVID-19 test in the past 3 months
Criteria for inclusion in the final study sample:
Aim 1. Symptomatic participants with a negative at-school BinaxNOW test and nasal PCR results who complete both the lollipop PCR and at-home BinaxNOW tests within 72 hours will be included in the final study sample.
Aim 2. Symptomatic participants who provide a lollipop swab that is successfully resulted.
Criteria for exclusion in the final study sample:
Aim 1

Show all 11Show fewer

Missing nasal PCR result
Do not successfully complete an at-home BinaxNOW test within 72 hours of the at-school BinaxNOW test
Aim 2
Missing nasal PCR result
Missing lollipop PCR result

Trial locations and contacts

1 site in 1 country.

United States1 site

Community Locations
Madison, Wisconsin, 53705

Other trials in United States

About this study

This study will target Madison Metropolitan School District (MMSD) school children ages 4-19 and staff who have not had a previous positive COVID-19 test within the past 3 months. It will enroll children and adults for 1-3 days to explore whether serial "at-home" BinaxNOW testing is feasible and non-inferior to "at school" single PCR testing for the evaluation of symptomatic individuals with a negative initial BinaxNOW. It will also explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with polymerase chain reaction (PCR) testing.

Read the detailed description

Study Design: This is a quantitative community-based study, conducted in the K-12 setting with school children 4-19 years old, teachers, and staff.

If a participant's initial at-school BinaxNOW test is positive, then they will only complete the lollipop swab for PCR testing. They will NOT do the at-home BinaxNOW test.

If a participant's initial at-school BinaxNOW test is negative, then they will complete both the lollipop swab for PCR testing AND an at-home BinaxNOW test approximately 24 hours later.

If the participant is unwilling or unable to complete the at-home test, they will be presented with a lollipop swab only option.

Aim 1: The investigators will test the hypothesis that serial at-home BinaxNOW testing will be feasible and non-inferior to the single at-school PCR testing program. To do this, the investigators will distribute over-the-counter BinaxNOW antigen tests to volunteer families, and create a protocol to ensure families can perform and report test results accurately to the school.

Two key questions will be addressed:

Is 'at-home' BinaxNOW testing feasible for families?
Is serial 'at-home' BinaxNOW testing non-inferior to 'at-school' single PCR testing?

Aim 2: The investigators will test the hypothesis that lollipop swabs are more acceptable to individuals and PCR testing is non-inferior to performing PCR on nasal swabs. To test this hypothesis, the investigators will work with MMSD schools to incorporate a lollipop swab for PCR at the time a symptomatic student or staff receives a nasal swab for PCR that is part of the Department of Health Services (DHS) program.

Two key questions will be addressed:

Are lollipop swabs more acceptable to individuals when compared to nasal swabs?
Will lollipop swabs perform as well as nasal swabs with PCR-based testing?

Hypotheses to be tested:

Aim 1.1: "At-home" BinaxNOW testing will be feasible for families.
Aim 1.2: Serial "at-home" BinaxNOW testing is non-inferior to "at school" single PCR testing.
Aim 2.1: Lollipop swabs are more acceptable to individuals than nasal swabs.
Aim 2.2: Lollipop swabs will perform as well as nasal swabs with PCR-based testing.

Protocol Amendment 2/4/22 to expand the upper eligible age for children from 14 to 19 years and to recognize the potential supply chain limitations of BinaxNOW tests. If the study team does not have any BinaxNOW tests due to a supply shortage, the BinaxNOW procedures will be dropped and only the lollipop swab will be collected.

Protocol Amendment 5/16/22 extends the study timeline and adds a lollipop swab only option.

Conditions: Sars-CoV-2 Infection, COVID-19
Being tested: BinaxNOW Test, "Lollipop" swab
Keywords: testing, diagnosis, schools
Medical subject headings: COVID-19, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BinaxNOW TestDiagnostic test
Also called BinaxNOW COVID-19 Ag Card
diagnostic test for SARS-CoV-2
"Lollipop" swabDiagnostic test
A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.

Study groups in NCT05105789
Study group	Role	What they receive
BinaxNOW Test + Lollipop PCR	Experimental	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. Receives: Diagnostic Test: BinaxNOW Test; Diagnostic Test: "Lollipop" swab

What is being measured

The primary outcome is the main question the study is designed to answer.

Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
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.
Measured: up to 2 days
Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results
Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value.
Measured: up to 2 days
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
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.
Measured: up to 2 days
Number of Successfully Completed At-home Tests
Feasibility 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).
Measured: up to 24 hours
Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs
To 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.
Measured: up to 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 202121 May 2023

First posted3 Nov 2021
Study start11 Oct 2021
Primary completion21 May 2023
Study completion21 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05105789
Sponsor's protocol ID: 2021-0790
Other IDs: Protocol Version 5/8/22, A536756
Status last verified: May 2024
First submitted: 21 Oct 2021
Last updated: 22 May 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sars-CoV-2 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safe and Healthy Schools
ClinicalTrials.gov ID: NCT05105789
Acronym / sponsor ID: 2021-0790
Conditions: Sars-CoV-2 Infection, COVID-19
Keywords: testing, diagnosis, schools
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 11 Oct 2021 (actual)
Primary completion: 21 May 2023 (actual)
Study completion: 21 May 2023 (actual)
First posted: 3 Nov 2021 (actual)
Results: Posted 22 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design: This is a quantitative community-based study, conducted in the K-12 setting with school children 4-19 years old, teachers, and staff.

If a participant's initial at-school BinaxNOW test is positive, then they will only complete the lollipop swab for PCR testing. They will NOT do the at-home BinaxNOW test.

If a participant's initial at-school BinaxNOW test is negative, then they will complete both the lollipop swab for PCR testing AND an at-home BinaxNOW test approximately 24 hours later.

If the participant is unwilling or unable to complete the at-home test, they will be presented with a lollipop swab only option.

Two key questions will be addressed:

Is 'at-home' BinaxNOW testing feasible for families?
Is serial 'at-home' BinaxNOW testing non-inferior to 'at-school' single PCR testing?

Two key questions will be addressed:

Are lollipop swabs more acceptable to individuals when compared to nasal swabs?
Will lollipop swabs perform as well as nasal swabs with PCR-based testing?

Hypotheses to be tested:

Aim 1.1: "At-home" BinaxNOW testing will be feasible for families.
Aim 1.2: Serial "at-home" BinaxNOW testing is non-inferior to "at school" single PCR testing.
Aim 2.1: Lollipop swabs are more acceptable to individuals than nasal swabs.
Aim 2.2: Lollipop swabs will perform as well as nasal swabs with PCR-based testing.

Protocol Amendment 5/16/22 extends the study timeline and adds a lollipop swab only option.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BinaxNOW Test + Lollipop PCR	Experimental	Diagnostic Test: BinaxNOW Test, Diagnostic Test: "Lollipop" swabIf 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.

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

school children ages 4-19
MMSD staff
have at least one symptom of COVID-19
have not had a positive COVID-19 test in the past 3 months
will undergo nasal PCR testing at an MMSD elementary school

Key exclusion criteria (11 listed)

received a positive COVID-19 test in the past 3 months
Aim 1. Symptomatic participants with a negative at-school BinaxNOW test and nasal PCR results who complete both the lollipop PCR and at-home BinaxNOW tests within 72 hours will be included in the final study sample.
Aim 2. Symptomatic participants who provide a lollipop swab that is successfully resulted.
Aim 1
Aim 2

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BinaxNOW TestAlso: BinaxNOW COVID-19 Ag Carddiagnostic test for SARS-CoV-2	Diagnostic test	BinaxNOW Test + Lollipop PCR
"Lollipop" swabA lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.	Diagnostic test	BinaxNOW Test + Lollipop PCR

Primary outcome

Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
Time frame: up to 2 days
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.
Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results
Time frame: up to 2 days
Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value.
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
Time frame: up to 2 days
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.
Number of Successfully Completed At-home Tests
Time frame: up to 24 hours
Feasibility 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).
Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs
Time frame: up to 1 day
To 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.

Results and safety

Results posted to the registry on 22 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COVID-19 Tests	100	99

Primary outcome: Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR

Time frame: up to 2 days. Number (95% Confidence Interval). Unit: kappa value in percentage

Measure	BinaxNOW At Home Testing n = 73
Sensitivity	100 (44 to 100)
Specificity	99 (92 to 100)
Positive Predictive Value	75 (30 to 99)
Negative Predictive Value	100 (95 to 100)

BinaxNOW At Home Testing: Kappa Co-efficient: 100 (95% CI 95 to 100), p = 0.0015, one-sample binomial test
BinaxNOW At Home Testing: p = 0.3308, one-sample binomial test
BinaxNOW At Home Testing: p = 0.0536, one-sample binomial test

Primary outcome: Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results

Time frame: up to 2 days. Count of units. Unit: COVID-19 tests

Measure	Negative Nasal Swab PCR n = 99	Positive Nasal Swab PCR n = 99
Lollipop PCR (Negative)	86	0
Lollipop PCR (Positive)	2	11

Negative Nasal Swab PCR vs Positive Nasal Swab PCR: Kappa Co-efficient: 0.91 (95% CI 0.78 to 1.00)

Population analysed: 1 device did not function properly, 99 participants had data from both test to analyze

Primary outcome: Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR

Time frame: up to 2 days. Number (95% Confidence Interval). Unit: kappa value in percentage

Measure	Lollipop Swab PCR Testing n = 99
Sensitivity	100 (74 to 100)
Specificity	98 (92 to 99)
Positive Predictive Value	85 (58 to 96)
Negative Predictive Value	100 (96 to 100)

Lollipop Swab PCR Testing: p = 0.2010, one-sample binomial test
Lollipop Swab PCR Testing: p = 0.0705, one-sample binomial test

Population analysed: 1 device did not function properly, 99 participants had data from both test to analyze

Primary outcome: Number of Successfully Completed At-home Tests

Time frame: up to 24 hours. Count of units. Unit: at home COVID-19 tests

Measure	At Home BinaxNOW Test n = 79
Value	73

Adverse events

Time frame: Adverse events were collected after consent was signed and until they completed study procedures during the school visit or during the Binax Now visit (up to 5 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COVID-19 Tests	0 of 100 (0%)	0 of 100 (0%)	0 of 100

Limitations and caveats (from the sponsor): Some limitations and caveats of this study include: * Difficulty enrolling participants because parents were not allowed into the school building for the informed consent procedure. * The outdoor consenting procedure became more difficult, and at times impossible, during extreme cold, or rainy weather days. * School holidays during COVID surges, and the COVID Clinic's proximity and lack of cooperation also created limitations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sars-CoV-2 Infection

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ellen R Wald, MD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BinaxNOW Test and "Lollipop" swab in people with Sars-CoV-2 Infection and COVID-19, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR (time frame: up to 2 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05105789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.