NOWDx Test for the Detection of Antibodies to COVID-19
1 other identifier
interventional
129
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Sep 2020
Shorter than P25 for not_applicable covid19
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
October 28, 2022
CompletedMarch 1, 2024
October 1, 2022
4 months
August 31, 2020
April 4, 2022
February 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Persons tested with investigational device
EXPERIMENTALPersons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test
Interventions
The investigational device is the NOWDx COVID-19 Test.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Persons \<18 years old;
- Persons who have previously participated in a NOWDx study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Del Sol Research Management, LLC
Tucson, Arizona, 85712, United States
Comprehensive Clinical Research, LLC
West Palm Beach, Florida, 33409, United States
Clinical Research Solutions, LLC
Jackson, Tennessee, 38305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Beth Cobb
- Organization
- NOWDiagnostics
Study Officials
- PRINCIPAL INVESTIGATOR
Beth L Cobb
NOWDiagnostics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
December 30, 2020
Study Start
September 1, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 1, 2024
Results First Posted
October 28, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share