Trial Outcomes & Findings for Evaluating Technologies for Point-of-Care Blood Collections by Patients (NCT NCT06507566)
NCT ID: NCT06507566
Last Updated: 2026-01-23
Results Overview
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Day 1
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
Cohort A
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
66
|
|
Overall Study
COMPLETED
|
120
|
57
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
Reasons for withdrawal
| Measure |
Cohort A
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Evaluating Technologies for Point-of-Care Blood Collections by Patients
Baseline characteristics by cohort
| Measure |
Cohort A
n=134 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B
n=66 Participants
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 17.22 • n=270 Participants
|
40.6 years
STANDARD_DEVIATION 15.79 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 16.74 • n=9 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=270 Participants
|
42 Participants
n=4 Participants
|
124 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=270 Participants
|
24 Participants
n=4 Participants
|
76 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=270 Participants
|
31 Participants
n=4 Participants
|
90 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=270 Participants
|
34 Participants
n=4 Participants
|
108 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=270 Participants
|
9 Participants
n=4 Participants
|
25 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=270 Participants
|
54 Participants
n=4 Participants
|
164 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Weight
|
85.67 kg
STANDARD_DEVIATION 23.99 • n=270 Participants
|
83.16 kg
STANDARD_DEVIATION 19.83 • n=4 Participants
|
84.84 kg
STANDARD_DEVIATION 22.68 • n=9 Participants
|
|
Height
|
1.69 m
STANDARD_DEVIATION 0.11 • n=270 Participants
|
1.69 m
STANDARD_DEVIATION 0.1 • n=4 Participants
|
1.69 m
STANDARD_DEVIATION 0.11 • n=9 Participants
|
|
BMI
|
30.03 kg/m^2
STANDARD_DEVIATION 7.7 • n=270 Participants
|
29.15 kg/m^2
STANDARD_DEVIATION 6.84 • n=4 Participants
|
29.74 kg/m^2
STANDARD_DEVIATION 7.42 • n=9 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion.
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Outcome measures
| Measure |
Total
n=186 Samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=123 Samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=63 Samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Sample Integrity of Tasso+™
|
40.5 percentage of samples
|
23.1 percentage of samples
|
75.8 percentage of samples
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort.
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=163 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Sample Integrity of Tasso+™
|
—
|
29.5 percentage of samples
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 57Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort.
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=140 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Sample Integrity of Tasso+™
|
—
|
28 percentage of samples
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion.
Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting
Outcome measures
| Measure |
Total
n=189 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=124 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=65 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Sample Integrity of Tasso+™
|
16.0 percentage of samples
|
2.2 percentage of samples
|
43.9 percentage of samples
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort.
Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=159 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Sample Integrity of Tasso+™
|
—
|
2.5 percentage of samples
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 57Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort.
Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=141 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Sample Integrity of Tasso+™
|
—
|
2.5 percentage of samples
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion.
Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort A
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=134 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™
Venipuncture/(SST or EDTA)
|
—
|
41.04 percentage of samples
|
—
|
—
|
|
Assess the Testing Accuracy of Tasso+™
Tasso+™/(SST or EDTA)
|
—
|
41.79 percentage of samples
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion.
Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort B
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™
Venipuncture/(SST or EDTA)
|
—
|
53.03 percentage of samples
|
—
|
—
|
|
Assess the Testing Accuracy of Tasso+™
Tasso+™/(SST or EDTA)
|
—
|
46.97 percentage of samples
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion.
Correlation of sodium between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=122 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=60 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Sodium
|
139.7 mmol/L
Standard Deviation 2.1
|
139.9 mmol/L
Standard Deviation 4.12
|
137.6 mmol/L
Standard Deviation 8.2
|
138.2 mmol/L
Standard Deviation 1.82
|
PRIMARY outcome
Timeframe: Day 1Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion.
Percentage of Tasso+™ device failure
Outcome measures
| Measure |
Total
n=199 Devices
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=133 Devices
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=66 Devices
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Reliability of Tasso+™
Device failure due to faulty mechanism
|
4 Devices
|
2 Devices
|
2 Devices
|
—
|
|
Assess the Reliability of Tasso+™
Device failure due to user error
|
2 Devices
|
1 Devices
|
1 Devices
|
—
|
|
Assess the Reliability of Tasso+™
No device failure
|
193 Devices
|
130 Devices
|
63 Devices
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort.
Percentage of Tasso+™ device failure
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=172 Devices
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Assess the Reliability of Tasso+™
Device failure due to faulty mechanism
|
—
|
8 Devices
|
—
|
—
|
|
To Assess the Reliability of Tasso+™
Device failure due to user error
|
—
|
0 Devices
|
—
|
—
|
|
To Assess the Reliability of Tasso+™
No Device Failures
|
—
|
164 Devices
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 57Population: Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort.
Percentage of Tasso+™ device failure
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=168 Devices
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Reliability of Tasso+™
Device failure due to faulty mechanism
|
—
|
8 Devices
|
—
|
—
|
|
Assess the Reliability of Tasso+™
Device failure due to user error
|
—
|
2 Devices
|
—
|
—
|
|
Assess the Reliability of Tasso+™
No device failures
|
—
|
158 Devices
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Full analysis
Correlation of potassium between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=122 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=60 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Potassium
|
4.42 mmol/L
Standard Deviation 0.44
|
4.31 mmol/L
Standard Deviation 0.51
|
6.89 mmol/L
Standard Deviation 1.8
|
4.65 mmol/L
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: Day 1Population: Full analysis
Correlation of chloride between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=122 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=60 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Chloride
|
106.3 mmol/L
Standard Deviation 2.06
|
105.8 mmol/L
Standard Deviation 2.48
|
104.2 mmol/L
Standard Deviation 3.7
|
108.7 mmol/L
Standard Deviation 2.59
|
PRIMARY outcome
Timeframe: Day 1Population: Full analysis
Correlation of creatinine between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=122 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=60 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Creatinine
|
71.67 μmol/L
Standard Deviation 24.78
|
71.37 μmol/L
Standard Deviation 34.9
|
64.27 μmol/L
Standard Deviation 36.03
|
67.15 μmol/L
Standard Deviation 26.1
|
PRIMARY outcome
Timeframe: Day 1Population: Full analysis
Correlation of glucose between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=121 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=59 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Glucose
|
5.23 mmol/L
Standard Deviation 1.92
|
5.33 mmol/L
Standard Deviation 1.63
|
1.38 mmol/L
Standard Deviation 1.72
|
5.58 mmol/L
Standard Deviation 2.17
|
PRIMARY outcome
Timeframe: Day 1Population: Full analysis
Correlation of phosphate between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=122 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=60 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Phosphate
|
1.1 mmol/L
Standard Deviation 0.17
|
1.1 mmol/L
Standard Deviation 0.18
|
1.98 mmol/L
Standard Deviation 1.87
|
1.08 mmol/L
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Day 1Population: Full analysis
Correlation of urate between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=120 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=59 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Urate
|
0.3 mmol/L
Standard Deviation 0.1
|
0.3 mmol/L
Standard Deviation 0.08
|
0.28 mmol/L
Standard Deviation 0.09
|
0.29 mmol/L
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Day 1Population: Full analysis
Correlation of C-reactive protein between venipuncture and Tasso+™/SST samples for each cohort
Outcome measures
| Measure |
Total
n=66 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=132 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=121 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
n=60 samples
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for C-reactive Protein
|
4.34 mg/L
Standard Deviation 7.89
|
5.19 mg/L
Standard Deviation 12.47
|
4.98 mg/L
Standard Deviation 11.54
|
4.44 mg/L
Standard Deviation 8.06
|
SECONDARY outcome
Timeframe: Within 7 days of Tasso+™ administrationPopulation: Full analysis
Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration
Outcome measures
| Measure |
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=134 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=66 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Safety)
|
110 Participants
|
71 Participants
|
39 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full analysis
Percentage of eligible subjects who experienced unsolicited AEs within 28 days of Tasso+™ administration
Outcome measures
| Measure |
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=134 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=66 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Safety)
|
28 Participants
|
15 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full analysis
Percentage of eligible subjects who experienced a related Grade 3 AE, a related Grade 4 AE, a related AE leading to study discontinuation, or a related SAE within 28 days of Tasso+™ administration
Outcome measures
| Measure |
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=134 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=66 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Safety)
Subjects experienced a related Grade 3 AE
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Safety)
Subjects experienced a related Grade 4 AE
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Safety)
Subjects experienced a related AE leading to discontinuation
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Safety)
Subjects experienced a related SAE
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 57Population: Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 57. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. Completion of Tasso+™ administration is not cohort specific as it was pre-specified to collect and report as a total for both cohorts.
Percentage of eligible participants who complete last Tasso+™ administration (Day 57)
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Tolerability)
|
—
|
153 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Outcome measures
| Measure |
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=134 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=66 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 1 (Easy)
|
138 Participants
|
100 Participants
|
38 Participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 2
|
25 Participants
|
13 Participants
|
12 Participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 3
|
6 Participants
|
0 Participants
|
3 Participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 4
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult)
|
6 Participants
|
3 Participants
|
3 Participants
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
22 Participants
|
14 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 29. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort. Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. .
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 1 (Easy)
|
—
|
130 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 2
|
—
|
11 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 3
|
—
|
5 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 4
|
—
|
2 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult)
|
—
|
6 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
—
|
46 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 57Population: Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 57. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration is not cohort specific as it was pre-specified to collect and report as a total for both cohorts.
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 1 (Easy)
|
—
|
137 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 2
|
—
|
8 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 3
|
—
|
2 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 4
|
—
|
3 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult)
|
—
|
5 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
—
|
45 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85Population: Full analysis including all subjects (cohorts A and B) as the willingness to use the Tasso device is not cohort specific as it was pre-specified to collect and report as a total for both cohorts.
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per year
|
—
|
13 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per month
|
—
|
32 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per week
|
—
|
17 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day
|
—
|
7 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? Never
|
—
|
3 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? As needed
|
—
|
97 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
—
|
31 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis
Percentage of eligible participants with a positive nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction (PCR) on Day 1
Outcome measures
| Measure |
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=134 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=66 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Perform Surveillance for SARS-CoV-2 Infection
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Between Days 1 and 57Population: Full analysis including all subjects (cohorts A and B) as Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57 is not cohort specific as it was pre-specified to collect and report as a total for both cohorts.
Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Perform Surveillance for SARS-CoV-2 Infection
|
—
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 29. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort as this outcome is not cohort specific as it was pre-specified to collect and report as a total for both cohorts.
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per year
|
—
|
6 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per month
|
—
|
24 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per week
|
—
|
24 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day
|
—
|
8 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? Never
|
—
|
1 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? As needed
|
—
|
91 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
—
|
46 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 57Population: Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 57. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. Willingness to use the Tasso device is not cohort specific as it was pre-specified to collect and report as a total for both cohorts.
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per year
|
—
|
9 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per month
|
—
|
22 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per week
|
—
|
22 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? Never
|
—
|
0 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? As needed
|
—
|
95 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
—
|
45 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day
|
—
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 1. The analysis population in the Day 1endpoints includes all subjects regardless of cohort as it was pre-specified to collect and report as a total for both cohorts.
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per year
|
—
|
8 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per month
|
—
|
25 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per week
|
—
|
22 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day
|
—
|
16 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? Never
|
—
|
2 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How often would you be willing to provide a blood sample using the Tasso+™ device? As needed
|
—
|
104 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
—
|
23 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85Population: Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 85. The analysis population in the Day 85 endpoints includes all subjects regardless of cohort. Determining the method for future blood sampling by the participant is not cohort specific as both cohorts had blood collected using the Tasso device and the venipuncture method and it was pre-specified to collect and report as a total for both cohorts.
Preferred method for future blood sampling was assessed by the participant completing the Tasso questionnaire
Outcome measures
| Measure |
Total
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=200 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate Tasso+™ User Experience (Usability)
How would you prefer future blood sampling? Tasso+™ device self-applied at home
|
—
|
134 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How would you prefer future blood sampling? Tasso+™ device applied at doctor's office or a lab
|
—
|
16 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How would you prefer future blood sampling? Venipuncture at doctor's office or a lab
|
—
|
10 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How would you prefer future blood sampling? Finger stick device self-applied at home
|
—
|
5 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
How would you prefer future blood sampling? Finger stick device applied at doctor's office or a lab
|
—
|
4 Participants
|
—
|
—
|
|
To Evaluate Tasso+™ User Experience (Usability)
Questionnaire results unknown
|
—
|
31 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 57Population: Per the SAP, the Per-Protocol Set will include all participants who successfully completed at least five Tasso+™ administrations and do not have any important protocol deviations. This analysis set will be used for sensitivity analyses.
Percentage of Tasso+™/SST samples collected that are with adequate volume and without moderate or gross hemolysis between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Outcome measures
| Measure |
Total
n=85 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=16 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=69 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity
|
47.2 percentage of samples
|
41.2 percentage of samples
|
48.6 percentage of samples
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 57Population: Per the SAP, the Per-Protocol Set will include all participants who successfully completed at least five Tasso+™ administrations and do not have any important protocol deviations. This analysis set will be used for sensitivity analyses.
Percentage of Tasso+™/EDTA samples collected that are with adequate volume and without moderate or gross hemolysis between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Outcome measures
| Measure |
Total
n=83 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=16 samples
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=67 samples
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity
|
5.6 percentage of samples
|
0 percentage of samples
|
6.9 percentage of samples
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 57Population: Per-Protocol
Percentage of Tasso+™ device failure between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Outcome measures
| Measure |
Total
n=89 devices
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=17 devices
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=72 devices
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Reliability
Device failure due to faulty mechanism
|
4.5 percentage of device failures
|
11.8 percentage of device failures
|
2.8 percentage of device failures
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Reliability
Device failure due to user error
|
0 percentage of device failures
|
0 percentage of device failures
|
0 percentage of device failures
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 7 days of Tasso+™ administration on Day 57, up to a maximum of 64 daysPopulation: Per-Protocol
Percentage of subjects with solicited local AEs within 7 days of Tasso+™ administration on Day 57 between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™
Outcome measures
| Measure |
Total
n=89 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=17 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=72 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Solicited local AEs
|
37 Participants
|
7 Participants
|
30 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
No solicited local AEs
|
52 Participants
|
10 Participants
|
42 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 28 days of Tasso+™ administration on Day 57, up to Day 85Population: Per-Protocol
Percentage of subjects with unsolicited AEs, related Grade 3 AE, related Grade 4 AE, related AE leading to discontinuation, or related SAE within 28 days of Tasso+™ administration on between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57
Outcome measures
| Measure |
Total
n=89 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=17 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=72 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Subjects experienced a related Grade 3 AE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Subjects experienced unsolicited AEs
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Subjects experienced a related Grade 4 AE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Subjects experienced a related AE leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
Subjects experienced a related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety
No unsolicited AEs, related Grade 3 AE, Grade 4 AE, AE leading to discontinuation, or SAE
|
88 Participants
|
16 Participants
|
72 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 57Population: Per-Protocol
Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Outcome measures
| Measure |
Total
n=89 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=17 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=72 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Questionnaire results unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Questionnaire how easy was the Tasso+™ device to use? Score: 1 (Easy)
|
78 Participants
|
13 Participants
|
65 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Questionnaire how easy was the Tasso+™ device to use? Score: 2
|
6 Participants
|
2 Participants
|
4 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Questionnaire how easy was the Tasso+™ device to use? Score: 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Questionnaire how easy was the Tasso+™ device to use? Score: 4
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult)
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 57Population: Per-Protocol
Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire
Outcome measures
| Measure |
Total
n=89 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Total
n=17 Participants
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
Cohort A (Tasso+™/SST)
n=72 Participants
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B (Tasso+™/SST)
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
|---|---|---|---|---|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per year
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per month
|
13 Participants
|
0 Participants
|
13 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per week
|
12 Participants
|
3 Participants
|
9 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day
|
3 Participants
|
0 Participants
|
3 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
How often would you be willing to provide a blood sample using the Tasso+™ device? None
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
How often would you be willing to provide a blood sample using the Tasso+™ device? As needed
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability
Questionnaire results unknown
|
57 Participants
|
13 Participants
|
44 Participants
|
—
|
Adverse Events
Cohort A
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Cohort B
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A
n=134 participants at risk
Samples centrifuged/aliquoted after arrival at central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Cohort B
n=66 participants at risk
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
Tasso+™: The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.
|
Total
n=200 participants at risk
All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab.
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.75%
1/134 • 3 months
|
1.5%
1/66 • 3 months
|
1.0%
2/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
2/134 • 3 months
|
1.5%
1/66 • 3 months
|
1.5%
3/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
2/134 • 3 months
|
1.5%
1/66 • 3 months
|
1.5%
3/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.5%
2/134 • 3 months
|
1.5%
1/66 • 3 months
|
1.5%
3/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Infections and infestations
Sinusitis
|
0.75%
1/134 • 3 months
|
3.0%
2/66 • 3 months
|
1.5%
3/200 • 3 months
|
|
Infections and infestations
Nasopharyngitis
|
0.75%
1/134 • 3 months
|
1.5%
1/66 • 3 months
|
1.0%
2/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
0.75%
1/134 • 3 months
|
0.00%
0/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Infections and infestations
COVID-19
|
0.75%
1/134 • 3 months
|
0.00%
0/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Infections and infestations
Ear infection
|
0.75%
1/134 • 3 months
|
0.00%
0/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Infections and infestations
Influenza
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
1.5%
2/134 • 3 months
|
0.00%
0/66 • 3 months
|
1.0%
2/200 • 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.75%
1/134 • 3 months
|
0.00%
0/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.75%
1/134 • 3 months
|
0.00%
0/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Investigations
Blood cholesterol increased
|
0.75%
1/134 • 3 months
|
0.00%
0/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/134 • 3 months
|
1.5%
1/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
Vascular disorders
Hypertension
|
0.75%
1/134 • 3 months
|
0.00%
0/66 • 3 months
|
0.50%
1/200 • 3 months
|
|
General disorders
Administration site erythema
|
23.9%
32/134 • 3 months
|
28.8%
19/66 • 3 months
|
25.5%
51/200 • 3 months
|
|
General disorders
Administration site swelling
|
15.7%
21/134 • 3 months
|
18.2%
12/66 • 3 months
|
16.5%
33/200 • 3 months
|
|
General disorders
Administration site bruise
|
11.9%
16/134 • 3 months
|
15.2%
10/66 • 3 months
|
13.0%
26/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
5/134 • 3 months
|
3.0%
2/66 • 3 months
|
3.5%
7/200 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
3/134 • 3 months
|
4.5%
3/66 • 3 months
|
3.0%
6/200 • 3 months
|
|
Nervous system disorders
Headache
|
0.75%
1/134 • 3 months
|
4.5%
3/66 • 3 months
|
2.0%
4/200 • 3 months
|
|
General disorders
Chills
|
0.75%
1/134 • 3 months
|
3.0%
2/66 • 3 months
|
1.5%
3/200 • 3 months
|
|
General disorders
Administration site pruritus
|
1.5%
2/134 • 3 months
|
1.5%
1/66 • 3 months
|
1.5%
3/200 • 3 months
|
|
General disorders
Administration site pain
|
32.1%
43/134 • 3 months
|
45.5%
30/66 • 3 months
|
36.5%
73/200 • 3 months
|
|
General disorders
Administration site scar
|
34.3%
46/134 • 3 months
|
36.4%
24/66 • 3 months
|
35.0%
70/200 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place