Inpatient COVID-19 Lollipop Study

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Diagnostic Test
• Intervention / Treatment: Device: Lollipop

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassandra Nelson, RN; Phone Number: 608-890-1589; Email: cenelson4@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to understand and the willingness to provide verbal informed consent, if 18 years or older. If 4-17 years old, ability to understand and the willingness to provide verbal assent, plus have a parent or legal guardian present who can provide verbal informed consent.
• Willing to comply with all study procedures and be available for the duration of the study.
• Admitted to UW Health University Hospital or UW Health Kids American Family Children's Hospital.
• Individuals at least 4 years of age.
• Verified COVID-19 according to positive NP PCR test criteria.
• Enroll within 47 hours of the diagnostic NP swab; lollipop swab collected within 48 hours of the diagnostic NP swab.
• Either personally able or have a parent or legal guardian able to verbally answer questions in English about clinical symptoms, exposures, and other health and demographic information.

Exclusion Criteria:

• Unable to suck on a swab.
• Previous participation in this study.
• Require translation services for medical care.
• Not suitable for study participation due to other reasons at the discretion of the investigators or their designee.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID-19 Positive Children; Determined by NP PCR test	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; Other Names: Lollipop collection swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity: True Positive Rate	NP vs. lollipop swab-based PCR COVID-19 tests. The True Positive Rate is the number of True Positive test results divided by the number of true positives and false negatives. Subgroup analysis of sensitivity of lollipop swabs will be calculated for asymptomatic, symptomatic (<7 days), and symptomatic (>7 days) individuals.	1 study visit (data collected in 20 seconds)
Specificity: True Negative Rate	NP vs. lollipop swab-based PCR COVID-19 tests. The True Negative Rate is the number of true negative test results divided by the number of true negative and false positives. Subgroup analysis of specificity of lollipop swabs will be calculated for asymptomatic, symptomatic (<7 days), and symptomatic (>7 days) individuals.	1 study visit (data collected in 20 seconds)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with discordant test results	A correlation of clinical characteristics to participants with discordant test results will be analyzed to better understand the efficacy of the diagnostic test.	1 study visit (data collected in 20 seconds)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Ellen Wald, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): May 24, 2023
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2023-0290; SMPH\PEDIATRICS\INFECT DIS (Other Identifier: UW Madison); Protocol Version 4/4/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes