Inpatient COVID-19 Lollipop Study
Purpose
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
Eligibility
- Eligible Ages
- Over 4 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental COVID-19 Positive Participants |
Determined by NP PCR test |
|
Recruiting Locations
More Details
- NCT ID
- NCT05801341
- Status
- Terminated
- Sponsor
- University of Wisconsin, Madison
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.