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Inpatient COVID-19 Lollipop Study

Primary Purpose

COVID-19, Diagnostic Test

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lollipop
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID-19 Positive Children

Arm Description

Determined by NP PCR test

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 4, 2023
Last Updated
July 25, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT05801341
Brief Title
Inpatient COVID-19 Lollipop Study
Official Title
The Utility of "Lollipop" Oral Swabs in the Diagnosis of COVID-19 in an Inpatient Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
May 24, 2023 (Actual)
Study Completion Date
May 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Diagnostic Test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 Positive Children
Arm Type
Experimental
Arm Description
Determined by NP PCR test
Intervention Type
Device
Intervention Name(s)
Lollipop
Other Intervention Name(s)
Lollipop collection swab
Intervention Description
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
Primary Outcome Measure Information:
Title
Sensitivity: True Positive Rate
Description
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.
Time Frame
1 study visit (data collected in 20 seconds)
Title
Specificity: True Negative Rate
Description
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.
Time Frame
1 study visit (data collected in 20 seconds)
Secondary Outcome Measure Information:
Title
Number of participants with discordant test results
Description
A correlation of clinical characteristics to participants with discordant test results will be analyzed to better understand the efficacy of the diagnostic test.
Time Frame
1 study visit (data collected in 20 seconds)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Wald, MD
Organizational Affiliation
UW School of Medicine and Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inpatient COVID-19 Lollipop Study

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