Back to resultsNOWDx Test for the Detection of Antibodies to COVID-19
Primary Purpose
COVID-19, SARS-CoV-2, Coronavirus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOWDx COVID-19 Test
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Persons ≥18 years old;
- Persons who have tested positive or negative (within 6 days) for COVID-19 with an emergency use authorized molecular (PCR) test and can furnish said test report.
Exclusion Criteria:
- Persons <18 years old;
- Persons who have previously participated in a NOWDx study.
Sites / Locations
- Del Sol Research Management, LLC
- Comprehensive Clinical Research, LLC
- Clinical Research Solutions, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Persons tested with investigational device
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04690413
Brief Title
NOWDx Test for the Detection of Antibodies to COVID-19
Official Title
NOWDx Test for the Detection of Antibodies to COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NOWDiagnostics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2, Coronavirus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Persons tested with investigational device
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
NOWDx COVID-19 Test
Intervention Description
The investigational device is the NOWDx COVID-19 Test.
Primary Outcome Measure Information:
Title
Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator.
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Persons ≥18 years old;
Persons who have tested positive or negative (within 6 days) for COVID-19 with an emergency use authorized molecular (PCR) test and can furnish said test report.
Exclusion Criteria:
Persons <18 years old;
Persons who have previously participated in a NOWDx study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth L Cobb
Organizational Affiliation
NOWDiagnostics, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Comprehensive Clinical Research, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Clinical Research Solutions, LLC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NOWDx Test for the Detection of Antibodies to COVID-19
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