Clinical trial NCT06507566: Evaluating Technologies for Point-of-Care Blood Collections by Patients
Official title: Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Tasso, Tasso+
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON Government and Public Health Solutions, Inc
name: Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
First posted: 2024-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the sample integrity of Tasso+™
timeFrame: Day 1
measure: To assess the sample integrity of Tasso+™
timeFrame: Day 29
measure: To assess the sample integrity of Tasso+™
timeFrame: Day 57
measure: To assess the sample integrity of Tasso+™
timeFrame: Day 1
measure: To assess the sample integrity of Tasso+™
timeFrame: Day 29
measure: To assess the sample integrity of Tasso+™
timeFrame: Day 57
measure: To assess the testing accuracy of Tasso+™
timeFrame: Day 1
measure: To assess the testing accuracy of Tasso+™
timeFrame: Day 1
measure: To assess the testing accuracy of Tasso+™ as compared to samples collected via venipuncture
timeFrame: Day 1
measure: To assess the testing accuracy of Tasso+™ as compared to samples collected via venipuncture
timeFrame: Day 1
measure: To assess the reliability of Tasso+™
timeFrame: Day 1
measure: To assess the reliability of Tasso+™
timeFrame: Day 29
measure: To assess the reliability of Tasso+™
timeFrame: Day 57
Secondary outcomes:
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 7 days after blood collection on Day 1
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 7 days after blood collection on Day 29
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 7 days after blood collection on Day 57
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 28 days after blood collection on Day 1
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 28 days after blood collection on Day 29
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 28 days after blood collection on Day 57
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 28 days after blood collection on Day 1
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 28 days after blood collection on Day 29
measure: To evaluate Tasso+™ user experience (Safety)
timeFrame: Within 28 days after blood collection on Day 57
measure: To evaluate Tasso+™ user experience (Tolerability)
timeFrame: Day 57
measure: To evaluate Tasso+™ user experience (Usability)
timeFrame: Day 1
measure: To evaluate Tasso+™ user experience (Usability)
timeFrame: Day 29
measure: To evaluate Tasso+™ user experience (Usability)
timeFrame: Day 57
measure: To evaluate Tasso+™ user experience (Usability)
timeFrame: Day 85
measure: To perform surveillance for SARS-CoV-2 infection
timeFrame: Day 1
measure: To perform surveillance for SARS-CoV-2 infection
timeFrame: Between Days 1 and 57
Other outcomes:
measure: To evaluate the impact of prior training on subsequent Tasso+™ administrations
timeFrame: 57
Locations:
city: Riverside
country: United States
facility: Victor Salib
state: California
Study officials:
References: