Evaluating Technologies for Point-of-Care Blood Collections by Patients
- Conditions
- Healthy
- Interventions
- Device: Tasso+™
- Registration Number
- NCT06507566
- Lead Sponsor
- Resilience Government Services, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A Tasso+™ Samples centrifuged/aliquoted after arrival at central lab. Cohort B Tasso+™ Samples centrifuged/aliquoted at collection Site before shipment to central lab.
- Primary Outcome Measures
Name Time Method To 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 B
To assess the sample integrity of Tasso+™ Day 57 Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting
To assess the testing accuracy of Tasso+™ as compared to samples collected via venipuncture Day 1 Correlation of each chemistry analyte (sodium, potassium, chloride, blood urea nitrogen, creatinine, glucose, phosphate, uric acid, and C-reactive protein) between venipuncture and Tasso+™/SST samples for Cohort B
To assess the reliability of Tasso+™ Day 57 Percentage of Tasso+™ device failure
- Secondary Outcome Measures
Name Time Method To evaluate Tasso+™ user experience (Safety) Within 28 days after blood collection on Day 57 Percentage of eligible participants who experience 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
To perform surveillance for SARS-CoV-2 infection Between Days 1 and 57 Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57
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 85 Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration
Trial Locations
- Locations (1)
Victor Salib
🇺🇸Riverside, California, United States