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: Terminated
• 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 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 Participants; 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
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests	Count of tests that detected COVID-19.	1 study visit (data collected in 20 seconds)
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.	1 study visit (data collected in 20 seconds)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Discordant Test Results	All participants were confirmed COVID-19 positive by nasal-swab PCR test to be eligible for this study. Participants all took a COVID-19 test via lollipop-swab. Reported here are the number of participants who did not test positive for COVID-19 via the lollipop-swab device (discordant results).	1 study visit (data collected in 20 seconds)
Summary of COVID-19 Clinical Characteristics by Participant Count	Count of participants who were: asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.	1 study visit (data collected up to 15 minutes)
Summary of COVID-19 Clinical Characteristics by Discordant Results	Of those with discordant results, how many were asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, or reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.	1 study visit (data collected in up to 10 minutes)

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): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

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