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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
| Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies | OTHER_GOV |
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A study evaluating technologies for point-of-care use in clinical trials.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Active Comparator | Samples centrifuged/aliquoted after arrival at central lab. |
|
| Cohort B | Active Comparator | Samples centrifuged/aliquoted at collection Site before shipment to central lab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasso+™ | Device | 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. |
| 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+™ |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victor Salib | Riverside | California | 92503 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Samples centrifuged/aliquoted after arrival at central lab. 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. |
| FG001 | Cohort B | Samples centrifuged/aliquoted at collection Site before shipment to central lab. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Samples centrifuged/aliquoted after arrival at central lab. 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. |
| BG001 | Cohort B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. | Posted | Number | percentage of samples | Day 1 | Samples | Samples |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A | Samples centrifuged/aliquoted after arrival at central lab. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angie Kimbler | Alachua Government Services, Inc. | 386-418-8751 | angie.kimbler@resilience.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2025 | Oct 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2025 | Oct 20, 2025 | SAP_001.pdf |
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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 |
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 |
| 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 |
Samples centrifuged/aliquoted at collection Site before shipment to central lab. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | m |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Cohort B | Samples centrifuged/aliquoted at collection Site before shipment to central lab. 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. |
| OG002 | Total | All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab. |
|
|
| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort. | Posted | Number | percentage of samples | Day 29 | samples | samples |
|
|
|
| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. | Posted | Number | percentage of samples | Day 57 | samples | samples |
|
|
|
| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. | Posted | Number | percentage of samples | Day 1 | samples | samples |
|
|
|
| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort. | Posted | Number | percentage of samples | Day 29 | samples | samples |
|
|
|
| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. | Posted | Number | percentage of samples | Day 57 | samples | samples |
|
|
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| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. | Posted | Number | percentage of samples | Day 1 | samples | samples |
|
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|
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| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. | Posted | Number | percentage of samples | Day 1 | samples | samples |
|
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| Primary | 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 | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. | Posted | Mean | Standard Deviation | mmol/L | Day 1 | samples | samples |
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| Primary | Assess the Reliability of Tasso+™ | Percentage of Tasso+™ device failure | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. | Posted | Count of Units | Devices | Day 1 | Devices | Devices |
|
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| Primary | To Assess the Reliability of Tasso+™ | Percentage of Tasso+™ device failure | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort. | Posted | Count of Units | Devices | Day 29 | Devices | Devices |
|
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| Primary | Assess the Reliability of Tasso+™ | Percentage of Tasso+™ device failure | Per the SAP, the full analysis set is defined as all participants who administered Tasso+™ either in a site-supervised, proctor supported, or unsupported setting (regardless of cohort). This analysis set will be the primary set used for analyses/summaries of the primary endpoint, as well as for secondary endpoints of seroconversion. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. | Posted | Count of Units | Devices | Day 57 | Devices | Devices |
|
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| Primary | 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 | Full analysis | Posted | Mean | Standard Deviation | mmol/L | Day 1 | samples | samples |
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| Primary | 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 | Full analysis | Posted | Mean | Standard Deviation | mmol/L | Day 1 | samples | samples |
|
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| Primary | 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 | Full analysis | Posted | Mean | Standard Deviation | μmol/L | Day 1 | samples | samples |
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| Primary | 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 | Full analysis | Posted | Mean | Standard Deviation | mmol/L | Day 1 | samples | samples |
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| Primary | 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 | Full analysis | Posted | Mean | Standard Deviation | mmol/L | Day 1 | samples | samples |
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| Primary | 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 | Full analysis | Posted | Mean | Standard Deviation | mmol/L | Day 1 | samples | samples |
|
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| Primary | 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 | Full analysis | Posted | Mean | Standard Deviation | mg/L | Day 1 | samples | samples |
|
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| Secondary | 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 | Full analysis | Posted | Count of Participants | Participants | Within 7 days of Tasso+™ administration |
|
|
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| Secondary | To Evaluate Tasso+™ User Experience (Safety) | Percentage of eligible subjects who experienced unsolicited AEs within 28 days of Tasso+™ administration | Full analysis | Posted | Count of Participants | Participants | Day 29 |
|
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| Secondary | 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 | Full analysis | Posted | Number | percentage of participants | Day 29 |
|
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| Secondary | To Evaluate Tasso+™ User Experience (Tolerability) | Percentage of eligible participants who complete last Tasso+™ administration (Day 57) | Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 57. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. Completion of Tasso+™ administration is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Day 57 |
|
|
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| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration | Full analysis | Posted | Count of Participants | Participants | Day 1 |
|
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| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration | Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 29. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort. Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. . | Posted | Count of Participants | Participants | Day 29 |
|
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|
| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration | Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 57. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Day 57 |
|
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| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire | Full analysis including all subjects (cohorts A and B) as the willingness to use the Tasso device is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Day 85 |
|
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| Secondary | 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 | Full analysis | Posted | Count of Participants | Participants | Day 1 |
|
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| Secondary | To Perform Surveillance for SARS-CoV-2 Infection | Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57 | Full analysis including all subjects (cohorts A and B) as Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57 is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Between Days 1 and 57 |
|
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| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire | Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 29. The analysis population in the Day 29 endpoints includes all subjects regardless of cohort as this outcome is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Day 29 |
|
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| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire | Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 57. The analysis population in the Day 57 endpoints includes all subjects regardless of cohort. Willingness to use the Tasso device is not cohort specific as it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Day 57 |
|
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| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire | Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 1. The analysis population in the Day 1endpoints includes all subjects regardless of cohort as it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | To Evaluate Tasso+™ User Experience (Usability) | Preferred method for future blood sampling was assessed by the participant completing the Tasso questionnaire | Full analysis including all subjects (Cohorts A and B) administered Tasso+™ on Day 85. The analysis population in the Day 85 endpoints includes all subjects regardless of cohort. Determining the method for future blood sampling by the participant is not cohort specific as both cohorts had blood collected using the Tasso device and the venipuncture method and it was pre-specified to collect and report as a total for both cohorts. | Posted | Count of Participants | Participants | Day 85 |
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| Other Pre-specified | 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 | Per the SAP, the Per-Protocol Set will include all participants who successfully completed at least five Tasso+™ administrations and do not have any important protocol deviations. This analysis set will be used for sensitivity analyses. | Posted | Number | percentage of samples | Day 57 | samples | samples |
|
|
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| Other Pre-specified | 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 | Per the SAP, the Per-Protocol Set will include all participants who successfully completed at least five Tasso+™ administrations and do not have any important protocol deviations. This analysis set will be used for sensitivity analyses. | Posted | Number | percentage of samples | Day 57 | samples | samples |
|
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| Other Pre-specified | 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 | Per-Protocol | Posted | Number | percentage of device failures | Day 57 | devices | devices |
|
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| Other Pre-specified | 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+™ | Per-Protocol | Posted | Count of Participants | Participants | Within 7 days of Tasso+™ administration on Day 57, up to a maximum of 64 days |
|
|
|
| Other Pre-specified | 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 | Per-Protocol | Posted | Count of Participants | Participants | Within 28 days of Tasso+™ administration on Day 57, up to Day 85 |
|
|
|
| Other Pre-specified | 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 | Per-Protocol | Posted | Count of Participants | Participants | Day 57 |
|
|
|
| Other Pre-specified | 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 | Per-Protocol | Posted | Count of Participants | Participants | Day 57 |
|
|
|
| 0 |
| 134 |
| 0 |
| 134 |
| 76 |
| 134 |
| EG001 | Cohort B | Samples centrifuged/aliquoted at collection Site before shipment to central lab. 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. | 0 | 66 | 0 | 66 | 40 | 66 |
| EG002 | Total | All subjects with samples centrifuged/aliquoted after arrival at central lab and samples centrifuged/aliquoted at collection site before shipment to central lab. | 0 | 200 | 0 | 200 | 116 | 200 |
| Administration site scar | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Administration site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Administration site swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Administration site bruise | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Administration site pruritus | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Acute sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Norovirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| samples |
|
| Correlation Contingency Coefficient | 0.59 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
| No device failure |
|
| samples |
|
| Correlation Contingency Coefficient | 0.22 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
| samples |
|
| Correlation Contingency Coefficient | 0.82 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
| samples |
|
| Correlation Contingency Coefficient | 0.99 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
| samples |
|
| Correlation Contingency Coefficient | 0.95 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
| samples |
|
| Correlation Contingency Coefficient | 0.95 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
| samples |
|
| Correlation Contingency Coefficient | 0.97 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
| samples |
|
| Correlation Contingency Coefficient | 1.0 | 2-Sided | Other | Pearson's correlation coefficient were computed to quantify the strength of the direction of the linear relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for SARS-CoV-2 serology. Contingency correlation coefficient was computed to estimate the extent of the relationship between the venipuncture collection and the Tasso+™ collection at Day 1 for each cohort for each chemistry analytes. |
|
| Subjects experienced a related AE leading to discontinuation |
|
| Subjects experienced a related SAE |
|
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 3 |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 4 |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult) |
|
| Questionnaire results unknown |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 4 |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult) |
|
| Questionnaire results unknown |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 4 |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult) |
|
| Questionnaire results unknown |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? Never |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? As needed |
|
| Questionnaire results unknown |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? Never |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? As needed |
|
| Questionnaire results unknown |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? Never |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? As needed |
|
| Questionnaire results unknown |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? Never |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? As needed |
|
| Questionnaire results unknown |
|
| How would you prefer future blood sampling? Finger stick device self-applied at home |
|
| How would you prefer future blood sampling? Finger stick device applied at doctor's office or a lab |
|
| Questionnaire results unknown |
|
|
| Subjects experienced a related Grade 4 AE |
|
| Subjects experienced a related AE leading to discontinuation |
|
| Subjects experienced a related SAE |
|
| No unsolicited AEs, related Grade 3 AE, Grade 4 AE, AE leading to discontinuation, or SAE |
|
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 3 |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 4 |
|
| Questionnaire how easy was the Tasso+™ device to use? Score: 5 (Difficult) |
|
| Questionnaire results unknown |
|
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per week |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? 1 per day |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? None |
|
| How often would you be willing to provide a blood sample using the Tasso+™ device? As needed |
|
| Questionnaire results unknown |
|