NCT04799392

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

March 14, 2021

Last Update Submit

October 28, 2021

Conditions

COVID-19SARS-CoV-2Coronavirus

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

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

Device: NOWDx COVID-19 Test

Interventions

NOWDx COVID-19 TestDEVICE

The investigational device is the NOWDx COVID-19 Test.

Persons tested with investigational device following PCR testPersons tested with investigational device following vaccination

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medical Arts Pharmacy

Fayetteville, Arkansas, 72701, United States

Location

Goodrich Pharmacy

Anoka, Minnesota, 55303, United States

Location

Alps Specialty Pharmacy

Nixa, Missouri, 65714, United States

Location

Alps Pharmacy

Springfield, Missouri, 65803, United States

Location

Bremo Pharmacy

Richmond, Virginia, 23230, United States

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Beth Cobb

    NOW Diagnostics, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 16, 2021

Study Start

April 1, 2021

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(5)