Clinical trial NCT05801341: 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
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
Diagnostic Test
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 17
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests
timeFrame: 1 study visit (data collected in 20 seconds)
measure: Sensitivity: True Positive Rate
timeFrame: 1 study visit (data collected in 20 seconds)
Secondary outcomes:
measure: Number of Participants With Discordant Test Results
timeFrame: 1 study visit (data collected in 20 seconds)
measure: Summary of COVID-19 Clinical Characteristics by Participant Count
timeFrame: 1 study visit (data collected up to 15 minutes)
measure: Summary of COVID-19 Clinical Characteristics by Discordant Results
timeFrame: 1 study visit (data collected in up to 10 minutes)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Ellen Wald, MD
role: PRINCIPAL_INVESTIGATOR
References: