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Status:

TERMINATED

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

Lead Sponsor:

NOWDiagnostics, Inc.

Conditions:

COVID-19

SARS-CoV-2

Eligibility:

All Genders

2+ years

Phase:

NA

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 ma...

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 ma...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 28 2021

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT04799392

    Start Date

    April 1 2021

    End Date

    October 28 2021

    Last Update

    November 5 2021

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    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