Lollipop COVID-19 Testing Study

Not Applicable

Withdrawn

• Conditions: COVID-19 Pandemic; SARS CoV 2 Infection; COVID-19
• Interventions: Diagnostic Test: Lollipop Swab

• Registration Number: NCT05472077
• Lead Sponsor: University of Wisconsin, Madison

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:

1. Are lollipop swabs more acceptable to individuals when compared to nasal swabs?

2. 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 Timeline

• Study First Submitted: 2022-07-21
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Status Verified: 2023-07
• Study Start: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with COVID-19 Symptom(s)	Lollipop Swab	Participants 4 years old or older with at least one COVID-19 symptom being tested for the virus

Primary Outcome Measures

Name	Time	Method
Participant Sample Collection Preference	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	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.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States