COVID-19NCT05472077
Lollipop COVID-19 Testing Study
A study testing Lollipop Swab in people with COVID-19 and SARS CoV 2 Infection, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with PCR testing. The study will be open to enrollment for both children and adults in the Madison community who have at least one COVID-19 symptom that has presented in the last 5 days and who have not had a positive… Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- COVID-19, SARS CoV 2 Infection, COVID-19 Pandemic
- What is being tested?
- Lollipop Swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2023to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 4 years or above
- Have at least one COVID-19 symptom that has presented in the last 5 days and will undergo a nasal PCR test at a local community testing site
Who cannot join
- Positive COVID-19 test in the past 3 months for a previous illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Saliva Testing for SARS-CoV-2 With Lollipop Swab
This study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with PCR testing. The study will be open to enrollment for both children and adults in the Madison community who have at least one COVID-19 symptom that has presented in the last 5 days and who have not had a positive COVID-19 test for a previous illness within the past 3 months. Participants can expect to be in the study for the duration of the swabbing, approximately 10 minutes.
Read the detailed description
This study 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 study team will work with local community testing sites to incorporate a lollipop swab for PCR at the time a symptomatic individual receives a nasal swab for PCR that is part of the DHS program. The study will address the following two key questions:
- 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?
Participants with at least one COVID-19 symptom will be asked to suck on a swab for 20 seconds, like sucking on a lollipop. They then will be asked which COVID-19 PCR testing they would prefer if they had to do the testing again, nasal PCR versus lollipop PCR.
- Conditions
- COVID-19, SARS CoV 2 Infection, COVID-19 Pandemic
- Being tested
- Lollipop Swab
- Keywords
- saliva collection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lollipop SwabDiagnostic test
The "lollipop" swab is a typical swab that would be used to obtain routine pharyngeal samples. Participants are instructed to suck on the swab for 20 second, as they would suck on a lollipop.
| Study group | Role | What they receive |
|---|---|---|
| Participants with COVID-19 Symptom(s) | Experimental | Participants 4 years old or older with at least one COVID-19 symptom being tested for the virus Receives: Diagnostic Test: Lollipop Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Sample Collection Preference
The acceptance of the lollipop swab relative to nasal swab collection will be measured by asking participants which sample collection method they prefer. Count of participants for each sample collection method will be reported.
Measured: Day 1 (up to 10 minutes)
Number of Positive COVID-19 Diagnoses
The investigators will compare results of the lollipop swab and nasal swab to assess the efficacy of the lollipop swab to diagnose COVID-19.
Measured: Day 1 (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 posted25 Jul 2022
- Study startJul 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Issues with the Enrollment Location
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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, University of Wisconsin, MadisonShelby O'Connor, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472077
- Sponsor's protocol ID
- 2022-1011
- Other IDs
- A536756, SMPH\PEDIATRICS\INFECT DIS, Protocol Version 07/15/2022
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva Testing for SARS-CoV-2 With Lollipop Swab
- ClinicalTrials.gov ID
- NCT05472077
- Acronym / sponsor ID
- 2022-1011
- Conditions
- COVID-19, SARS CoV 2 Infection, COVID-19 Pandemic
- Keywords
- saliva collection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Issues with the Enrollment Location
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with PCR testing. The study will be open to enrollment for both children and adults in the Madison community who have at least one COVID-19 symptom that has presented in the last 5 days and who have not had a positive COVID-19 test for a previous illness within the past 3 months. Participants can expect to be in the study for the duration of the swabbing, approximately 10 minutes.
Detailed description
This study 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 study team will work with local community testing sites to incorporate a lollipop swab for PCR at the time a symptomatic individual receives a nasal swab for PCR that is part of the DHS program. The study will address the following two key questions:
- 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?
Participants with at least one COVID-19 symptom will be asked to suck on a swab for 20 seconds, like sucking on a lollipop. They then will be asked which COVID-19 PCR testing they would prefer if they had to do the testing again, nasal PCR versus lollipop PCR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with COVID-19 Symptom(s) | Experimental | Diagnostic Test: Lollipop SwabParticipants 4 years old or older with at least one COVID-19 symptom being tested for the virus |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 4 years or above
- Have at least one COVID-19 symptom that has presented in the last 5 days and will undergo a nasal PCR test at a local community testing site
Key exclusion criteria (1 listed)
- Positive COVID-19 test in the past 3 months for a previous illness
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 |
|---|---|---|
| Lollipop SwabThe "lollipop" swab is a typical swab that would be used to obtain routine pharyngeal samples. Participants are instructed to suck on the swab for 20 second, as they would suck on a lollipop. | Diagnostic test | Participants with COVID-19 Symptom(s) |
Primary outcome
Participant Sample Collection Preference
Time frame: Day 1 (up to 10 minutes)
The acceptance of the lollipop swab relative to nasal swab collection will be measured by asking participants which sample collection method they prefer. Count of participants for each sample collection method will be reported.
Number of Positive COVID-19 Diagnoses
Time frame: Day 1 (up to 10 minutes)
The investigators will compare results of the lollipop swab and nasal swab to assess the efficacy of the lollipop swab to diagnose COVID-19.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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
University of Wisconsin, Madison
Shelby O'Connor, 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 Lollipop Swab in people with COVID-19 and SARS CoV 2 Infection, 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 27 Jul 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Participant Sample Collection Preference (time frame: Day 1 (up to 10 minutes)). 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 27 Jul 2023.