Inpatient COVID-19 Lollipop Study

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05801341
• Other study ID #: 2023-0290
• Secondary ID: Protocol Version
• Status: Terminated
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests	Count of tests that detected COVID-19.	1 study visit (data collected in 20 seconds)
Primary	Sensitivity: True Positive Rate	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.	1 study visit (data collected in 20 seconds)
Secondary	Number of Participants With Discordant Test Results	All participants were confirmed COVID-19 positive by nasal-swab PCR test to be eligible for this study. Participants all took a COVID-19 test via lollipop-swab. Reported here are the number of participants who did not test positive for COVID-19 via the lollipop-swab device (discordant results).	1 study visit (data collected in 20 seconds)
Secondary	Summary of COVID-19 Clinical Characteristics by Participant Count	Count of participants who were: asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.	1 study visit (data collected up to 15 minutes)
Secondary	Summary of COVID-19 Clinical Characteristics by Discordant Results	Of those with discordant results, how many were asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, or reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.	1 study visit (data collected in up to 10 minutes)