Inpatient COVID-19 Lollipop Study

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05801341

Collaborator

(none)

225

Enrollment

Location

Arm

Anticipated Duration (Months)

37.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Diagnostic Test	Device: Lollipop	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sensitivity: True Positive Rate [1 study visit (data collected in 20 seconds)]
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 [1 study visit (data collected in 20 seconds)]
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 [1 study visit (data collected in 20 seconds)]
A correlation of clinical characteristics to participants with discordant test results will be analyzed to better understand the efficacy of the diagnostic test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator: Ellen Wald, MD, UW School of Medicine and Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT05801341

Other Study ID Numbers:

2023-0290
Protocol Version 4/4/2023
SMPH\PEDIATRICS\INFECT DIS

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 11, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 11, 2023