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This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).
The NOWDx COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing of human venous whole blood (EDTA) and fingerstick specimens are intended to be conducted in patient care settings authorized to perform CLIA waived tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persons tested with investigational device | Experimental | Persons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOWDx COVID-19 Test | Device | The investigational device is the NOWDx COVID-19 Test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator. | Calculate positive percent agreement (PPA) and negative percent agreement (NPA) between NOWDx COVID-19 Test and emergency use authorized or FDA cleared COVID-19 PCR Test. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth L Cobb | NOWDiagnostics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Del Sol Research Management, LLC | Tucson | Arizona | 85712 | United States | ||
| Comprehensive Clinical Research, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Persons Tested With Investigational Device | Persons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test NOWDx COVID-19 Test: The investigational device is the NOWDx COVID-19 Test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Persons Tested With Investigational Device | Persons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test NOWDx COVID-19 Test: The investigational device is the NOWDx COVID-19 Test. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator. | Calculate positive percent agreement (PPA) and negative percent agreement (NPA) between NOWDx COVID-19 Test and emergency use authorized or FDA cleared COVID-19 PCR Test. | Posted | Number | percentage of results matching PCR | 1 day |
|
|
Sites were required to report adverse events to the Sponsor within 10 days. Serious adverse events were required to be reported to the Sponsor within 24 hours. All adverse event data were required to be collected through study completion, an average of 4 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 | Persons Tested With Investigational Device | Persons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test NOWDx COVID-19 Test: The investigational device is the NOWDx COVID-19 Test. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Cobb | NOWDiagnostics | 479-966-4531 | beth.cobb@nowdx.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 | Jul 22, 2020 | Feb 1, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2020 | Feb 1, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| West Palm Beach |
| Florida |
| 33409 |
| United States |
| Clinical Research Solutions, LLC | Jackson | Tennessee | 38305 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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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| Participants |
|
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| 0 |
| 124 |
| 0 |
| 124 |
| 0 |
| 124 |
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |