Inpatient COVID-19 Lollipop Study

Purpose

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.

Conditions

  • COVID-19
  • Diagnostic Test

Eligibility

Eligible Ages
Over 4 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT05801341
Status
Terminated
Sponsor
University of Wisconsin, Madison

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.