NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
NCT ID: NCT04799392
Last Updated: 2021-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
50 participants
INTERVENTIONAL
2021-04-01
2021-10-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 fingerstick whole blood is intended to be conducted in a home-like setting of a facility authorized to perform CLIA waived tests.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Persons tested with investigational device following PCR test
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.
Persons tested with investigational device following vaccination
Persons tested with investigational device who previously were vaccinated for COVID-19 with an emergency use authorized or FDA cleared COVID-19 vaccine
NOWDx COVID-19 Test
The investigational device is the NOWDx COVID-19 Test.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NOWDx COVID-19 Test
The investigational device is the NOWDx COVID-19 Test.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* PCR positives: persons who were symptomatic for COVID-19 and have tested positive for COVID-19 with an EUA or FDA cleared PCR test; 7+ days post positive PCR test
* PCR negatives: persons who have never had COVID-19 and who have tested negative for COVID-19 with an EUA or FDA cleared PCR test; within 0-6 days post negative PCR test
* persons 2+ years old
Vaccination Cohort\>
* persons 7- 60 days post second dose of EUA COVID-19 vaccine
* persons 18+ years old
Exclusion Criteria
* PCR positives: persons with a COVID-19 positive test result \>45 days old
* PCR negatives: persons with any prior COVID-19 positive result
* persons who have received COVID-19 vaccine
* persons \<2 years old
Vaccination Cohort\>
* persons symptomatic or previously infected with COVID-19 prior to vaccination
* persons \<18 years old
2 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NOWDiagnostics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beth Cobb
Role: PRINCIPAL_INVESTIGATOR
NOW Diagnostics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Arts Pharmacy
Fayetteville, Arkansas, United States
Goodrich Pharmacy
Anoka, Minnesota, United States
Alps Specialty Pharmacy
Nixa, Missouri, United States
Alps Pharmacy
Springfield, Missouri, United States
Bremo Pharmacy
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NOWDx COVID-19 Antibody OTC
Identifier Type: -
Identifier Source: org_study_id