Lollipop COVID-19 Testing Study

NCT05472077 | Withdrawn DMC FDA Device

• 4 other identifiers: 2022-1011A536756SMPH\PEDIATRICS\INFECT DISProtocol Version 07/15/2022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with PCR testing. The study will be open to enrollment for both children and adults in the Madison community who have at least one COVID-19 symptom that has presented in the last 5 days and who have not had a positive COVID-19 test for a previous illness within the past 3 months. Participants can expect to be in the study for the duration of the swabbing, approximately 10 minutes.

Conditions

COVID-19; SARS CoV 2 Infection; COVID-19 Pandemic

Keywords

saliva collection

Outcome Measures

Primary Outcomes (2)

• Participant Sample Collection Preference

  The acceptance of the lollipop swab relative to nasal swab collection will be measured by asking participants which sample collection method they prefer. Count of participants for each sample collection method will be reported.

  Day 1 (up to 10 minutes)

• Number of Positive COVID-19 Diagnoses

  The investigators will compare results of the lollipop swab and nasal swab to assess the efficacy of the lollipop swab to diagnose COVID-19.

  Day 1 (up to 10 minutes)

Study Arms (1)

Participants with COVID-19 Symptom(s)

EXPERIMENTAL

Participants 4 years old or older with at least one COVID-19 symptom being tested for the virus

Diagnostic Test: Lollipop Swab

Interventions

Lollipop Swab DIAGNOSTIC_TEST

The "lollipop" swab is a typical swab that would be used to obtain routine pharyngeal samples. Participants are instructed to suck on the swab for 20 second, as they would suck on a lollipop.

Participants with COVID-19 Symptom(s)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 4 years or above
• Have at least one COVID-19 symptom that has presented in the last 5 days and will undergo a nasal PCR test at a local community testing site

You may not qualify if:

• Positive COVID-19 test in the past 3 months for a previous illness

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ellen Wald, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Shelby O'Connor, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: July 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)