Inpatient COVID-19 Lollipop Study

University of Wisconsin (UW)

Status

Terminated

Conditions

COVID-19

Diagnostic Test

Treatments

Device: Lollipop

Study type

Interventional

Funder types

Other

Identifiers

NCT05801341

SMPH\PEDIATRICS\INFECT DIS (Other Identifier)

Protocol Version 4/4/2023 (Other Identifier)

2023-0290

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

4+ years old

Volunteers

No 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.