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| ID | Type | Description | Link |
|---|---|---|---|
| 75A50122C00039 | Other Grant/Funding Number | United States Department of Health and Human |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.
GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel, graphene-based, point-of-care device | Experimental | Subjects will receive one additional nasal swab at the same time as clinical collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRIP Electronic Diagnostic Chip | Device | Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive Percent Agreement | Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing | One hour |
| Negative Percent Agreement | Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing | One hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Binnicker, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel, Graphene-based, Point-of-care Device | Subjects will receive one additional nasal swab at the same time as clinical collection. GRIP Electronic Diagnostic Chip: Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab Laboratory-based nucleic acid amplification tests (NAATs): Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel, Graphene-based, Point-of-care Device | Subjects will receive one additional nasal swab at the same time as clinical collection. GRIP Electronic Diagnostic Chip: Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab Laboratory-based nucleic acid amplification tests (NAATs): Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab |
| 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 | Positive Percent Agreement | Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing | Posted | Number | percent of nasal swabs | One hour | nasal swabs | nasal swabs |
|
Adverse events were collected from time of enrollment until completion of nasal swab, approximately one hour for each participant.
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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 | Novel, Graphene-based, Point-of-care Device | Subjects will receive one additional nasal swab at the same time as clinical collection. GRIP Electronic Diagnostic Chip: Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab Laboratory-based nucleic acid amplification tests (NAATs): Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Binicker | Mayo Clinic | 507-284-3697 | binnicker.matthew@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2022 | Feb 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Laboratory-based nucleic acid amplification tests (NAATs) | Diagnostic Test | Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
| nasal swabs |
|
|
| Primary | Negative Percent Agreement | Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing | Posted | Number | percent of nasal swabs | One hour | nasal swabs | nasal swabs |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |