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

Sponsor
NOWDiagnostics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04799392
Collaborator
(none)
50
5
2
6.9
10
1.4

Study Details

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: NOWDx COVID-19 Test
N/A

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

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Oct 28, 2021
Actual Study Completion Date :
Oct 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

Experimental: 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

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator [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.

  2. Positivity rate of NOWDx COVID-19 Tests in vaccinated persons [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Arts Pharmacy Fayetteville Arkansas United States 72701
2 Goodrich Pharmacy Anoka Minnesota United States 55303
3 Alps Specialty Pharmacy Nixa Missouri United States 65714
4 Alps Pharmacy Springfield Missouri United States 65803
5 Bremo Pharmacy Richmond Virginia United States 23230

Sponsors and Collaborators

  • NOWDiagnostics, Inc.

Investigators

  • Principal Investigator: Beth Cobb, NOW Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NOWDiagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT04799392
Other Study ID Numbers:
  • NOWDx COVID-19 Antibody OTC
First Posted:
Mar 16, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2021