Lollipop COVID-19 Testing Study

NCT ID: NCT05472077

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2023-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Participants with COVID-19 Symptom(s)

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

Group Type: EXPERIMENTAL

Lollipop Swab

Intervention Type: DIAGNOSTIC_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.

Interventions

Lollipop Swab

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Wald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Shelby O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

A536756

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\PEDIATRICS\INFECT DIS

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 07/15/2022

Identifier Type: OTHER

Identifier Source: secondary_id

2022-1011

Identifier Type: -

Identifier Source: org_study_id