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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 4/4/2023 | Other Identifier | UW Madison | |
| SMPH\PEDIATRICS\INFECT DIS | Other Identifier | UW Madison |
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Lab evaluation of lollipop samples no longer available.
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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.
This is a prospective quantitative study evaluating the utility of a novel method of saliva collection for COVID-19 testing.
Primary Objective
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Positive Participants | Experimental | Determined by NP PCR test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Wald, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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COVID-19 positive participants were enrolled at UWHealth from April to May 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Positive Participants | Participants were determined to be COVID-19 positive by NP PCR test for eligibility and subsequently tested for COVID-19 with Lollipop Swab PCR by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Positive Participants | Participants were determined to be COVID-19 positive by NP PCR test for eligibility and subsequently tested for COVID-19 with Lollipop Swab PCR by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests | Count of tests that detected COVID-19. | Posted | Count of Units | COVID-19 tests | No | 1 study visit (data collected in 20 seconds) | COVID-19 tests | COVID-19 tests |
|
AEs were collected after the signing of consent until study procedures were completed (survey and sample collection, up to 15 minutes).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID-19 Positive Participants | Participants were determined to be COVID-19 positive by NP PCR test for eligibility and subsequently tested for COVID-19 with Lollipop Swab PCR by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Wald, MD | UW School of Medicine and Public Health | (608) 263-8558 | erwald@pediatrics.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2023 | Feb 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| 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) |
| 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) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| COVID-19 tests |
|
|
| 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. | Posted | Number | percentage | 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). | Posted | Count of Participants | Participants | 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 participant described symptoms that the study team determined were unrelated to COVID-19, and this participant is reported as asymptomatic here. | Posted | Count of Participants | Participants | 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. | Participants with discordant COVID-19 test results. 1 participant described symptoms that the study team determined were unrelated to COVID-19, and this participant is reported as asymptomatic here. | Posted | Count of Participants | Participants | 1 study visit (data collected in up to 10 minutes) |
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|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |