COVID-19NCT04799392
NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
A study testing NOWDx COVID-19 Test in people with COVID-19 and SARS-CoV-2, run by NOWDiagnostics, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2, Coronavirus
- What is being tested?
- NOWDx COVID-19 Test
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Apr 2021to 28 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Innate Infection Cohort>
- 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
Who cannot join
- Innate Infection Cohort>
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Goodrich Pharmacy
Anoka, Minnesota, 55303
Medical Arts Pharmacy
Fayetteville, Arkansas, 72701
Alps Specialty Pharmacy
Nixa, Missouri, 65714
Bremo Pharmacy
Richmond, Virginia, 23230
Alps Pharmacy
Springfield, Missouri, 65803
About this study
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 fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.
Read the 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 fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.
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
- COVID-19, SARS-CoV-2, Coronavirus
- Being tested
- NOWDx COVID-19 Test
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOWDx COVID-19 TestDevice
The investigational device is the NOWDx COVID-19 Test.
| Study group | Role | What they receive |
|---|---|---|
| Persons tested with investigational device following PCR test | 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 Receives: Device: NOWDx COVID-19 Test |
| Persons tested with investigational device following vaccination | Experimental | Persons tested with investigational device who previously were vaccinated for COVID-19 with an emergency use authorized or FDA cleared COVID-19 vaccine Receives: Device: NOWDx COVID-19 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion; an average of 2 months
Positivity rate of NOWDx COVID-19 Tests in vaccinated persons
Calculate positivity rate of NOWDx COVID-19 Tests in persons post emergency use authorized or FDA cleared COVID-19 vaccination.
Measured: through study completion; an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Apr 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Why it stopped: FDA will not authorize COVID-19 Ab tests for use over-the-counter.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NOWDiagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beth Cobb, Principal investigator, NOW Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799392
- Sponsor's protocol ID
- NOWDx COVID-19 Antibody OTC
- Status last verified
- Oct 2021
- First submitted
- 14 Mar 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
- ClinicalTrials.gov ID
- NCT04799392
- Acronym / sponsor ID
- NOWDx COVID-19 Antibody OTC
- Conditions
- COVID-19, SARS-CoV-2, Coronavirus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA will not authorize COVID-19 Ab tests for use over-the-counter.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NOWDiagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.
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 fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons tested with investigational device following PCR test | Experimental | Device: NOWDx COVID-19 TestPersons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test |
| Persons tested with investigational device following vaccination | Experimental | Device: NOWDx COVID-19 TestPersons tested with investigational device who previously were vaccinated for COVID-19 with an emergency use authorized or FDA cleared COVID-19 vaccine |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Innate Infection Cohort>
- 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>
Key exclusion criteria (8 listed)
- Innate Infection Cohort>
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOWDx COVID-19 TestThe investigational device is the NOWDx COVID-19 Test. | Device | Persons tested with investigational device following PCR test, Persons tested with investigational device following vaccination |
Primary outcome
Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator
Time frame: through study completion; an average of 2 months
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.
Positivity rate of NOWDx COVID-19 Tests in vaccinated persons
Time frame: through study completion; an average of 2 months
Calculate positivity rate of NOWDx COVID-19 Tests in persons post emergency use authorized or FDA cleared COVID-19 vaccination.
Results and safety
The study was stopped early (reason given: FDA will not authorize COVID-19 Ab tests for use over-the-counter.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Cobb principal investigator
NOW Diagnostics, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOWDx COVID-19 Test in people with COVID-19 and SARS-CoV-2, run by NOWDiagnostics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: FDA will not authorize COVID-19 Ab tests for use over-the-counter.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator (time frame: through study completion; an average of 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.