Lollipop COVID-19 Testing Study

University of Wisconsin (UW)

Status: Withdrawn

Conditions: COVID-19; SARS CoV 2 Infection; COVID-19 Pandemic

Treatments: Diagnostic Test: Lollipop Swab

Study type: Interventional

Funder types: Other

Identifiers

NCT05472077

A536756 (Other Identifier)

2022-1011

SMPH\PEDIATRICS\INFECT DIS (Other Identifier)

Protocol Version 07/15/2022 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Participants with COVID-19 Symptom(s)

Experimental group

Description:

Participants 4 years old or older with at least one COVID-19 symptom being tested for the virus

Treatment:

Diagnostic Test: Lollipop Swab