Trial Outcomes & Findings for Inpatient COVID-19 Lollipop Study (NCT NCT05801341)
NCT ID: NCT05801341
Last Updated: 2024-06-07
Results Overview
Count of tests that detected COVID-19.
TERMINATED
NA
17 participants
1 study visit (data collected in 20 seconds)
2024-06-07
Participant Flow
COVID-19 positive participants were enrolled at UWHealth from April to May 2023.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inpatient COVID-19 Lollipop Study
Baseline characteristics by cohort
| Measure |
COVID-19 Positive Participants
n=17 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 study visit (data collected in 20 seconds)Count of tests that detected COVID-19.
Outcome measures
| Measure |
NP Swab Results
n=17 COVID-19 tests
NP Swab PCR used to diagnose COVID-19 for eligibility.
|
Lollipop Swab Results
n=17 COVID-19 tests
Lollipop Swab sample collection device to test against gold-standard nasal swab PCR
|
|---|---|---|
|
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests
Covid-19 Detected
|
17 COVID-19 tests
|
4 COVID-19 tests
|
|
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests
Covid-19 Not Detected
|
0 COVID-19 tests
|
13 COVID-19 tests
|
PRIMARY outcome
Timeframe: 1 study visit (data collected in 20 seconds)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.
Outcome measures
| Measure |
NP Swab Results
n=17 Participants
NP Swab PCR used to diagnose COVID-19 for eligibility.
|
Lollipop Swab Results
Lollipop Swab sample collection device to test against gold-standard nasal swab PCR
|
|---|---|---|
|
Sensitivity: True Positive Rate
|
23.5 percentage
|
—
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SECONDARY outcome
Timeframe: 1 study visit (data collected in 20 seconds)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).
Outcome measures
| Measure |
NP Swab Results
n=17 Participants
NP Swab PCR used to diagnose COVID-19 for eligibility.
|
Lollipop Swab Results
Lollipop Swab sample collection device to test against gold-standard nasal swab PCR
|
|---|---|---|
|
Number of Participants With Discordant Test Results
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 study visit (data collected up to 15 minutes)Population: 1 participant described symptoms that the study team determined were unrelated to COVID-19, and this participant is reported as asymptomatic here.
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.
Outcome measures
| Measure |
NP Swab Results
n=17 Participants
NP Swab PCR used to diagnose COVID-19 for eligibility.
|
Lollipop Swab Results
Lollipop Swab sample collection device to test against gold-standard nasal swab PCR
|
|---|---|---|
|
Summary of COVID-19 Clinical Characteristics by Participant Count
Asymptomatic
|
7 Participants
|
—
|
|
Summary of COVID-19 Clinical Characteristics by Participant Count
Symptomatic for less than 5 days
|
3 Participants
|
—
|
|
Summary of COVID-19 Clinical Characteristics by Participant Count
Symptomatic for 5 days or greater
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 study visit (data collected in up to 10 minutes)Population: 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.
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.
Outcome measures
| Measure |
NP Swab Results
n=13 Participants
NP Swab PCR used to diagnose COVID-19 for eligibility.
|
Lollipop Swab Results
Lollipop Swab sample collection device to test against gold-standard nasal swab PCR
|
|---|---|---|
|
Summary of COVID-19 Clinical Characteristics by Discordant Results
Asymptomatic
|
7 Participants
|
—
|
|
Summary of COVID-19 Clinical Characteristics by Discordant Results
Symptomatic for less than 5 days
|
2 Participants
|
—
|
|
Summary of COVID-19 Clinical Characteristics by Discordant Results
Symptomatic for 5 days or greater
|
4 Participants
|
—
|
Adverse Events
COVID-19 Positive Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ellen Wald, MD
UW School of Medicine and Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place