Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801341
Status:
TERMINATED
Last Update Posted:
2024-06-07
First Post:
2023-04-04
Brief Title:
Inpatient COVID-19 Lollipop Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
The Utility of Lollipop Oral Swabs in the Diagnosis of COVID-19 in an Inpatient Setting
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lab evaluation of lollipop samples no longer available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SMPHPEDIATRICSINFECT DIS | OTHER | UW Madison | None |
| Protocol Version 442023 | OTHER | None | None |