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Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™) | Clinical Trials | Clareo Health

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Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)

Clinical Evaluation of a SARS-CoV-2 CoviDx™COVID-19 Antigen Self-Test

NCT05403346•Lumos Diagnostics

View on ClinicalTrials.gov

Summary

Prospective study that will evaluate the clinical agreement of the CoviDx™ Self test compared to SARS-CoV-2 RT-PCR.

Detailed Description

Subjects who are currently experiencing symptoms associated with COVID-19 will be enrolled. Each enrolled subject will either self-collect one sample from the anterior nares or have the sample collected by another lay individual. Each subject will then have a mid-turbinate nasal swab sample collected for comparator test

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Mid-turbinate nasal swab collected for SARS-CoV-2 RT-PCR at the same time of CoviDx Rapid Antigen swab collection
•Symptomatic subjects suspected of having COVID-19, first onset of COVID-19-like symptoms (e.g., chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) should not have started more than 5 days from the time of the study visit. Symptoms must be present on the day of CoviDx testing.
•≥ 2 years of age
•Participants between 2-13 years of age, inclusive, must participate with a guardian who will be collecting the swab.
•Signed Informed Consent

Exclusion Criteria

•Participants with prior medical or laboratory training
•Unable or unwilling to provide signed, Informed Consent
•Less than 2 years of age
•Received a positive diagnostic test result for COVID-19 in the past 14 days
•Received a negative diagnostic test result for COVID-19 in the last 18 hours
•Study Comparator collection that occurred \> 3 hours from CoviDx swab collection
•For symptomatic participants: first onset of COVID-19-like symptoms occurring more than 5 days from study visit
•Invalid or missing study comparator test results
•Use of a non-high-sensitive SARS-CoV-2 test as the comparator SARS-CoV-2 RT-PCR test (e.g., rapid molecular, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study)
•Enrollment in another study involving the collection of a nasopharyngeal, mid-turbinate nasal swab or anterior nasal swab within 6 hours of CoviDx testing.
+3 more criteria

Locations (1)

PAS Research

Tampa, Florida, United States

Key Dates

Start Date

May 17, 2022

Primary Completion Date

August 1, 2022

Completion Date

October 31, 2022

Last Updated

November 16, 2022

Enrollment

ACTUAL participants

Conditions

SARS-CoV-2Covid19

Interventions

CoviDx™ Covid-19 Antigen Self-Test

DEVICE

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

NCT05141058

SARS-CoV-2 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Evaluation of a COVID-19 Antigen Self-Test (CoviDx™)

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

COVID-19 - Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study