Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assess the Sample Integrity of Tasso+™
研究概览
简要总结
A study evaluating technologies for point-of-care use in clinical trials.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Cohort A
Samples centrifuged/aliquoted after arrival at central lab.
干预措施: Tasso+™ (Device)
Cohort B
Samples centrifuged/aliquoted at collection Site before shipment to central lab.
干预措施: Tasso+™ (Device)
结局指标
主要结局
Assess the Sample Integrity of Tasso+™
时间窗: 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 Sample Integrity of Tasso+™
时间窗: Day 29
Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis
Assess the Sample Integrity of Tasso+™
时间窗: Day 57
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+™
时间窗: 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
时间窗: Day 1
Correlation of sodium between venipuncture and Tasso+™/SST samples for each cohort
Assess the Reliability of Tasso+™
时间窗: Day 1
Percentage of Tasso+™ device failure
To Assess the Reliability of Tasso+™
时间窗: Day 29
Percentage of Tasso+™ device failure
Assess the Reliability of Tasso+™
时间窗: Day 57
Percentage of Tasso+™ device failure
Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Potassium
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Day 1
Correlation of C-reactive protein between venipuncture and Tasso+™/SST samples for each cohort
次要结局
- To Evaluate Tasso+™ User Experience (Safety)(Within 7 days of Tasso+™ administration)
- To Evaluate Tasso+™ User Experience (Safety)(Day 29)
- To Evaluate Tasso+™ User Experience (Tolerability)(Day 57)
- To Evaluate Tasso+™ User Experience (Usability)(Day 1)
- To Evaluate Tasso+™ User Experience (Usability)(Day 29)
- To Evaluate Tasso+™ User Experience (Usability)(Day 57)
- To Evaluate Tasso+™ User Experience (Usability)(Day 85)
- To Perform Surveillance for SARS-CoV-2 Infection(Day 1)
- To Perform Surveillance for SARS-CoV-2 Infection(Between Days 1 and 57)