COVID-19NCT05801341
Inpatient COVID-19 Lollipop Study
A study testing Lollipop in people with COVID-19 and Diagnostic Test, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- COVID-19, Diagnostic Test
- What is being tested?
- Lollipop
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 24 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to provide verbal informed consent, if 18 years or older. If 4-17 years old, ability to understand and the willingness to provide verbal assent, plus have a parent or legal guardian present who can provide verbal informed consent.
- Willing to comply with all study procedures and be available for the duration of the study.
- Admitted to UW Health University Hospital or UW Health Kids American Family Children's Hospital.
- Individuals at least 4 years of age.
- Verified COVID-19 according to positive NP PCR test criteria.
- Enroll within 47 hours of the diagnostic NP swab; lollipop swab collected within 48 hours of the diagnostic NP swab.
- Either personally able or have a parent or legal guardian able to verbally answer questions in English about clinical symptoms, exposures, and other health and demographic information.
Who cannot join
- Unable to suck on a swab.
- Previous participation in this study.
- Require translation services for medical care.
- Not suitable for study participation due to other reasons at the discretion of the investigators or their designee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of "Lollipop" Oral Swabs in the Diagnosis of COVID-19 in an Inpatient Setting
This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.
Read the detailed description
This is a prospective quantitative study evaluating the utility of a novel method of saliva collection for COVID-19 testing.
Primary Objective
- To determine the performance characteristics of oral lollipop swabs compared to Nasal Pharyngeal (NP) swabs for diagnosing COVID-19 via PCR molecular testing.
Secondary Objectives
- To identify clinical characteristics of patients when there are discordant results for NP and oral lollipop test results.
- Conditions
- COVID-19, Diagnostic Test
- Being tested
- Lollipop
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LollipopDevice
Also called Lollipop collection swab
An oral lollipop swab will be obtained by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive Participants | Experimental | Determined by NP PCR test Receives: Device: Lollipop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests
Count of tests that detected COVID-19.
Measured: 1 study visit (data collected in 20 seconds)
Sensitivity: True Positive Rate
NP vs. lollipop swab-based PCR COVID-19 tests. The True Positive Rate is the number of True Positive test results divided by the number of true positives and false negatives.
Measured: 1 study visit (data collected in 20 seconds)
Secondary outcomes (3)
Number of Participants With Discordant Test Results
All participants were confirmed COVID-19 positive by nasal-swab PCR test to be eligible for this study. Participants all took a COVID-19 test via lollipop-swab. Reported here are the number of participants who did not test positive for COVID-19 via the lollipop-swab device (discordant results).
Measured: 1 study visit (data collected in 20 seconds)
Summary of COVID-19 Clinical Characteristics by Participant Count
Count of participants who were: asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.
Measured: 1 study visit (data collected up to 15 minutes)
Summary of COVID-19 Clinical Characteristics by Discordant Results
Of those with discordant results, how many were asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, or reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.
Measured: 1 study visit (data collected in up to 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start20 Apr 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Why it stopped: Lab evaluation of lollipop samples no longer available.
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 COVID-19Studies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Wald, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801341
- Sponsor's protocol ID
- 2023-0290
- Other IDs
- Protocol Version 4/4/2023, SMPH\PEDIATRICS\INFECT DIS
- Status last verified
- Jun 2024
- First submitted
- 4 Apr 2023
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of "Lollipop" Oral Swabs in the Diagnosis of COVID-19 in an Inpatient Setting
- ClinicalTrials.gov ID
- NCT05801341
- Acronym / sponsor ID
- 2023-0290
- Conditions
- COVID-19, Diagnostic Test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lab evaluation of lollipop samples no longer available.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Posted 23 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.
Detailed description
This is a prospective quantitative study evaluating the utility of a novel method of saliva collection for COVID-19 testing.
Primary Objective
- To determine the performance characteristics of oral lollipop swabs compared to Nasal Pharyngeal (NP) swabs for diagnosing COVID-19 via PCR molecular testing.
Secondary Objectives
- To identify clinical characteristics of patients when there are discordant results for NP and oral lollipop test results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive Participants | Experimental | Device: LollipopDetermined by NP PCR test |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and the willingness to provide verbal informed consent, if 18 years or older. If 4-17 years old, ability to understand and the willingness to provide verbal assent, plus have a parent or legal guardian present who can provide verbal informed consent.
- Willing to comply with all study procedures and be available for the duration of the study.
- Admitted to UW Health University Hospital or UW Health Kids American Family Children's Hospital.
- Individuals at least 4 years of age.
- Verified COVID-19 according to positive NP PCR test criteria.
Key exclusion criteria (4 listed)
- Unable to suck on a swab.
- Previous participation in this study.
- Require translation services for medical care.
- Not suitable for study participation due to other reasons at the discretion of the investigators or their designee.
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 |
|---|---|---|
| LollipopAlso: Lollipop collection swabAn oral lollipop swab will be obtained by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop | Device | COVID-19 Positive Participants |
Primary outcome
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests
Time frame: 1 study visit (data collected in 20 seconds)
Count of tests that detected COVID-19.
Sensitivity: True Positive Rate
Time frame: 1 study visit (data collected in 20 seconds)
NP vs. lollipop swab-based PCR COVID-19 tests. The True Positive Rate is the number of True Positive test results divided by the number of true positives and false negatives.
3 secondary outcomes
Number of Participants With Discordant Test Results
Time frame: 1 study visit (data collected in 20 seconds)
Summary of COVID-19 Clinical Characteristics by Participant Count
Time frame: 1 study visit (data collected up to 15 minutes)
Summary of COVID-19 Clinical Characteristics by Discordant Results
Time frame: 1 study visit (data collected in up to 10 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Wald, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lollipop in people with COVID-19 and Diagnostic Test, 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Jun 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 23 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?
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests (time frame: 1 study visit (data collected in 20 seconds)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.