Evaluating Technologies for Point-of-Care Blood Collections by Patients
NCT Number: NCT06507566
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DEVICE: Tasso+™
Sponsor: Resilience Government Services, Inc.
Collaborators: ICON Government and Public Health Solutions, Inc|Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-07

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

Primary Outcome Measures: To 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|To 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|To 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|To 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|To 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|To 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|To 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|To 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|To assess the testing accuracy of Tasso+™ as compared to samples collected via venipuncture, 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 A, Day 1|To assess the testing accuracy of Tasso+™ as compared to samples collected via venipuncture, 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, Day 1|To 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|To assess the reliability of Tasso+™, Percentage of Tasso+™ device failure, Day 57
Secondary Outcome Measures: 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 after blood collection on Day 1|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 after blood collection on Day 29|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 after blood collection on Day 57|To evaluate Tasso+™ user experience (Safety), Percentage of eligible participants who experience unsolicited AEs within 28 days of Tasso+™ administration, Within 28 days after blood collection on Day 1|To evaluate Tasso+™ user experience (Safety), Percentage of eligible participants who experience unsolicited AEs within 28 days of Tasso+™ administration, Within 28 days after blood collection on Day 29|To evaluate Tasso+™ user experience (Safety), Percentage of eligible participants who experience unsolicited AEs within 28 days of Tasso+™ administration, Within 28 days after blood collection on Day 57|To evaluate Tasso+™ user experience (Safety), 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, Within 28 days after blood collection on Day 1|To evaluate Tasso+™ user experience (Safety), 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, Within 28 days after blood collection on Day 29|To evaluate Tasso+™ user experience (Safety), 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, Within 28 days after blood collection on Day 57|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), Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration, 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
Other Outcome Measures: To evaluate the impact of prior training on subsequent Tasso+™ administrations, Comparative analyses of sample integrity, reliability, safety, and usability between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57, 57