Inpatient COVID-19 Lollipop Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2023-05-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Diagnostic Test

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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COVID-19 Positive Participants

Determined by NP PCR test

Group Type EXPERIMENTAL

Lollipop

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Lollipop collection swab

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No