Lollipop COVID-19 Testing Study
Primary Purpose
COVID-19, SARS CoV 2 Infection, COVID-19 Pandemic
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lollipop Swab
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 focused on measuring saliva collection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Positive COVID-19 test in the past 3 months for a previous illness
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with COVID-19 Symptom(s)
Arm Description
Participants 4 years old or older with at least one COVID-19 symptom being tested for the virus
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05472077
First Posted
July 21, 2022
Last Updated
July 24, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05472077
Brief Title
Lollipop COVID-19 Testing Study
Official Title
Saliva Testing for SARS-CoV-2 With Lollipop Swab
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Issues with the Enrollment Location
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS CoV 2 Infection, COVID-19 Pandemic
Keywords
saliva collection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with COVID-19 Symptom(s)
Arm Type
Experimental
Arm Description
Participants 4 years old or older with at least one COVID-19 symptom being tested for the virus
Intervention Type
Diagnostic Test
Intervention Name(s)
Lollipop Swab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant Sample Collection Preference
Description
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.
Time Frame
Day 1 (up to 10 minutes)
Title
Number of Positive COVID-19 Diagnoses
Description
The investigators will compare results of the lollipop swab and nasal swab to assess the efficacy of the lollipop swab to diagnose COVID-19.
Time Frame
Day 1 (up to 10 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Positive COVID-19 test in the past 3 months for a previous illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Wald, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shelby O'Connor, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lollipop COVID-19 Testing Study
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