NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons

COVID-19 Clinical Trial

Official title:

NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04799392
• Other study ID #: NOWDx COVID-19 Antibody OTC
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: October 28, 2021

Study information

• Verified date: October 2021
• Source: NOWDiagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

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 Exclusion criteria: 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

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• SARS-CoV-2

Intervention

Device:
• NOWDx COVID-19 Test
The investigational device is the NOWDx COVID-19 Test.

Locations

Country	Name	City	State
United States	Goodrich Pharmacy	Anoka	Minnesota
United States	Medical Arts Pharmacy	Fayetteville	Arkansas
United States	Alps Specialty Pharmacy	Nixa	Missouri
United States	Bremo Pharmacy	Richmond	Virginia
United States	Alps Pharmacy	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
NOWDiagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	through study completion; an average of 2 months
Primary	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.	through study completion; an average of 2 months