Healthy
Conditions
Keywords
Tasso, Tasso+
Brief summary
A study evaluating technologies for point-of-care use in clinical trials.
Detailed description
A study evaluating the Tasso+ blood collection device that enables the safe and convenient collection of blood by a lay person (eg, patient or study participant) under the supervision of an Health Care Provider.
Interventions
DEVICETasso+™
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.
Sponsors
Alachua Government Services, Inc.
ICON Government and Public Health Solutions, Inc
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female adults (18 years of age or older, inclusive), at the time of informed consent. Participants who are deemed pregnant by urine pregnancy test at Screening remain eligible. * Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions. * Participant considered healthy or in well-compensated health according to medical history, concomitant medications, and physical examination (including vital signs).
Exclusion criteria
* Medical history, or physical examination (including vital signs) findings, that suggest to the Investigator that the participant has undiagnosed or untreated medical condition(s) that could confound the AE evaluation and thereby undermine the study objectives. * Any known medical history of infection with HIV (CD4\<200 and/or detectable viral load within the prior 3 months), hepatitis B (positive HBsAg), or hepatitis C (positive hepatitis C virus antibody). * Chronic illness for which a participant's immune system is suspected by the Investigator to be impaired or altered, such as cancer, autoimmune conditions, and diabetes. * Participation in another investigational study within 30 days of time of consent or plans to do so during the course of this study. * Large tattoos or skin eruptions overlying either of the deltoid muscles that could confound the monitoring for local reactogenicity following Tasso+™ administrations. * Use of systemic immunomodulatory therapy, including oral corticosteroids, within the past 6 months; or planned use of medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to screening until end of study. * Acute illness within 14 days prior to device use unless it is determined by the Investigator that the illness is mild in severity and unlikely to progress. * Of limited legal capacity. * Any condition (including suspected alcohol- or drug-related addiction) that precludes adequate understanding, cooperation, and/or compliance with study procedures or any condition that could pose a risk to the participant's safety per Investigator judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Sample Integrity of Tasso+™ | Day 1 | Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis |
| Assess the Testing Accuracy of Tasso+™ | Day 1 | Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort A |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Sodium | Day 1 | Correlation of sodium between venipuncture and Tasso+™/SST samples for each cohort |
| Assess the Reliability of Tasso+™ | Day 1 | Percentage of Tasso+™ device failure |
| To Assess the Reliability of Tasso+™ | Day 29 | Percentage of Tasso+™ device failure |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Potassium | Day 1 | Correlation of potassium between venipuncture and Tasso+™/SST samples for each cohort |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Chloride | Day 1 | Correlation of chloride between venipuncture and Tasso+™/SST samples for each cohort |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Creatinine | Day 1 | Correlation of creatinine between venipuncture and Tasso+™/SST samples for each cohort |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Glucose | Day 1 | Correlation of glucose between venipuncture and Tasso+™/SST samples for each cohort |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Phosphate | Day 1 | Correlation of phosphate between venipuncture and Tasso+™/SST samples for each cohort |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Urate | Day 1 | Correlation of urate between venipuncture and Tasso+™/SST samples for each cohort |
| Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for C-reactive Protein | Day 1 | Correlation of C-reactive protein between venipuncture and Tasso+™/SST samples for each cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate Tasso+™ User Experience (Safety) | Within 7 days of Tasso+™ administration | Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration |
| To Evaluate Tasso+™ User Experience (Tolerability) | Day 57 | Percentage of eligible participants who complete last Tasso+™ administration (Day 57) |
| To Evaluate Tasso+™ User Experience (Usability) | Day 1 | Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration |
| To Perform Surveillance for SARS-CoV-2 Infection | Day 1 | Percentage of eligible participants with a positive nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction (PCR) on Day 1 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 16.74 |
| BMI | 30.03 kg/m^2 STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 1.69 m STANDARD_DEVIATION 0.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 164 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 52 Participants |
| Weight | 83.16 kg STANDARD_DEVIATION 19.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 134 | 0 / 66 | 0 / 200 |
| other Total, other adverse events | 76 / 134 | 40 / 66 | 116 / 200 |
| serious Total, serious adverse events | 0 / 134 | 0 / 66 | 0 / 200 |
Outcome results
None listed