NCT05801341

Inpatient COVID-19 Lollipop Study

The Utility of "Lollipop" Oral Swabs in the Diagnosis of COVID-19 in an Inpatient Setting

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to see if collecting saliva samples with a "lollipop" collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.

Detailed description

This is a prospective quantitative study evaluating the utility of a novel method of saliva collection for COVID-19 testing. Primary Objective * To determine the performance characteristics of oral lollipop swabs compared to Nasal Pharyngeal (NP) swabs for diagnosing COVID-19 via PCR molecular testing. Secondary Objectives * To identify clinical characteristics of patients when there are discordant results for NP and oral lollipop test results.

Conditions

• COVID-19
• Diagnostic Test

Interventions

Type	Name	Description
DEVICE	Lollipop	An oral lollipop swab will be obtained by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop

Timeline

• Start date: 2023-04-20
• Primary completion: 2023-05-24
• Completion: 2023-05-24
• First posted: 2023-04-06
• Last updated: 2024-06-07
• Results posted: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study