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

October 28, 2021 updated by: NOWDiagnostics, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • Medical Arts Pharmacy
    • Minnesota
      • Anoka, Minnesota, United States, 55303
        • Goodrich Pharmacy
    • Missouri
      • Nixa, Missouri, United States, 65714
        • Alps Specialty Pharmacy
      • Springfield, Missouri, United States, 65803
        • Alps Pharmacy
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Bremo Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion; an average of 2 months
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.
through study completion; an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NOWDiagnostics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

October 28, 2021

Study Completion (ACTUAL)

October 28, 2021

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 14, 2021

First Posted (ACTUAL)

March 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOWDx COVID-19 Antibody OTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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