Evaluating Technologies for Point-of-Care Blood Collections by Patients

Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings

A study evaluating technologies for point-of-care use in clinical trials.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Tasso+™

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92503
      • Victor Salib

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort A; Samples centrifuged/aliquoted after arrival at central lab.	Device: 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.
Active Comparator: Cohort B; Samples centrifuged/aliquoted at collection Site before shipment to central lab.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the Sample Integrity of Tasso+™	Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis	Day 1
Assess the Sample Integrity of Tasso+™	Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis	Day 29
Assess the Sample Integrity of Tasso+™	Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis	Day 57
Assess the Sample Integrity of Tasso+™	Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting	Day 1
Assess the Sample Integrity of Tasso+™	Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting	Day 29
Assess the Sample Integrity of Tasso+™	Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting	Day 57
Assess the Testing Accuracy of Tasso+™	Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort A	Day 1
Assess the Testing Accuracy of Tasso+™	Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort B	Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Sodium	Correlation of sodium between venipuncture and Tasso+™/SST samples for each cohort	Day 1
Assess the Reliability of Tasso+™	Percentage of Tasso+™ device failure	Day 1
To Assess the Reliability of Tasso+™	Percentage of Tasso+™ device failure	Day 29
Assess the Reliability of Tasso+™	Percentage of Tasso+™ device failure	Day 57
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Potassium	Correlation of potassium between venipuncture and Tasso+™/SST samples for each cohort	Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Chloride	Correlation of chloride between venipuncture and Tasso+™/SST samples for each cohort	Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Creatinine	Correlation of creatinine between venipuncture and Tasso+™/SST samples for each cohort	Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Glucose	Correlation of glucose between venipuncture and Tasso+™/SST samples for each cohort	Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Phosphate	Correlation of phosphate between venipuncture and Tasso+™/SST samples for each cohort	Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Urate	Correlation of urate between venipuncture and Tasso+™/SST samples for each cohort	Day 1
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for C-reactive Protein	Correlation of C-reactive protein between venipuncture and Tasso+™/SST samples for each cohort	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Evaluate Tasso+™ User Experience (Safety)	Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration	Within 7 days of Tasso+™ administration
To Evaluate Tasso+™ User Experience (Safety)	Percentage of eligible subjects who experienced unsolicited AEs within 28 days of Tasso+™ administration	Day 29
To Evaluate Tasso+™ User Experience (Safety)	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	Day 29
To Evaluate Tasso+™ User Experience (Tolerability)	Percentage of eligible participants who complete last Tasso+™ administration (Day 57)	Day 57
To Evaluate Tasso+™ User Experience (Usability)	Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration	Day 1
To Evaluate Tasso+™ User Experience (Usability)	Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration	Day 29
To Evaluate Tasso+™ User Experience (Usability)	Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration	Day 57
To Evaluate Tasso+™ User Experience (Usability)	Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire	Day 85
To Perform Surveillance for SARS-CoV-2 Infection	Percentage of eligible participants with a positive nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction (PCR) on Day 1	Day 1
To Perform Surveillance for SARS-CoV-2 Infection	Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57	Between Days 1 and 57
To Evaluate Tasso+™ User Experience (Usability)	Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire	Day 29
To Evaluate Tasso+™ User Experience (Usability)	Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire	Day 57
To Evaluate Tasso+™ User Experience (Usability)	Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire	Day 1
To Evaluate Tasso+™ User Experience (Usability)	Preferred method for future blood sampling was assessed by the participant completing the Tasso questionnaire	Day 85

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity	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	Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity	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	Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Reliability	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	Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety	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+™	Within 7 days of Tasso+™ administration on Day 57, up to a maximum of 64 days
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety	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	Within 28 days of Tasso+™ administration on Day 57, up to Day 85
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability	Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration	Day 57
To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability	Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire	Day 57

Collaborators and Investigators

• Sponsor: Alachua Government Services, Inc.
• Collaborators: Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies; ICON Government and Public Health Solutions, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Tasso, Tasso+
• Other Study ID Numbers: 5309/0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes