Inpatient COVID-19 Lollipop Study

NCT05801341 | Terminated Results FDA Device

• 3 other identifiers: 2023-0290Protocol Version 4/4/2023SMPH\PEDIATRICS\INFECT DIS
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Diagnostic Test

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Number of Participants With Discordant Test Results

  1 study visit (data collected in 20 seconds)

• Summary of COVID-19 Clinical Characteristics by Participant Count

  1 study visit (data collected up to 15 minutes)

• Summary of COVID-19 Clinical Characteristics by Discordant Results

  1 study visit (data collected in up to 10 minutes)

Study Arms (1)

COVID-19 Positive Participants

EXPERIMENTAL

Determined by NP PCR test

Device: Lollipop

Interventions

Lollipop 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

Also known as: Lollipop collection swab

COVID-19 Positive Participants

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, 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

Limitations and Caveats

Statistical Analyses were not completed as planned because of premature termination. Participant population were patients with a positive PCR screening test at the time of admission to the hospital regardless of their history of acute respiratory symptoms. Study not powered per protocol for meaningful results.

Results Point of Contact

• Title: Ellen Wald, MD
• Organization: UW School of Medicine and Public Health

erwald@pediatrics.wisc.edu

(608) 263-8558

Study Officials

• Ellen Wald, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 4, 2023
• First Posted: April 6, 2023
• Study Start: April 20, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: June 7, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)