COVID-19 Molecular OTC At Home Test

September 25, 2023 updated by: 3EO Health

Prospective, Multi-Center, Non-Randomized Study to Evaluate OTC At Home SARS-CoV-2 Molecular Diagnostic Test

The objective of this study is to evaluate the a molecular, OTC/At-Home COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the at-home molecular COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the sponsor (e.g., AN [anterior nares] swab) to determine accuracy of the at-home/OTC molecular COVID-19 Test in detecting COVID-19 in participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The molevular, at-home COVID-19 Test is a unique rapid molecular test system intended to detect SARS-CoV-2 virus in the OTC setting using a dedicated reusable test reader to test nasal swab samples. Early testing will help to determine limit of detection (LOD) of the molecular COVID-19 Test and will be compared to a sensitive molecular test that has been authorized for emergency use by the FDA. The COVID-19 Test will leverage the processing and testing of the associated Swab device when inserted directly into the reaction tube (Key) where reverse transcription, Loop-Mediated Isothermal DNA Amplifications (LAMP) processing and sequence-specific probe technologies to detect segments of the SARS-CoV-2 genome are managed automatically by the reusable test reader.

Study Type

Interventional

Enrollment (Actual)

202

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 Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33144
        • Bright Research Center
        • Contact:
          • Luis Mendez-Mulet, MD
          • Phone Number: 786-870-5487
        • Contact:
      • Miami, Florida, United States, 33144
        • I.V.A.M. Clinical & Investigational Center
    • Texas
      • Humble, Texas, United States, 77346
        • Vytalus Medical Atascocita
      • Kingwood, Texas, United States, 77339
        • Vytalus Medical

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

All Participants must meet ALL of the following:

  1. ≥ 2 years of age. Subjects ages 2 ≤ x ≤ 17 will provide assent in addition to parent / legal guardian's consent.
  2. Able to read and write in English and/or Spanish (subjects or guardians)
  3. Willing and able to provide informed consent (subject or Legally authorized Representative (LAR)). Subjects unable to consent will provide assent in addition to LAR consent.

Symptomatic Participants must meet BOTH of the following:

  1. Have at least one of the following symptoms the day of the test:

    1. Fever
    2. Cough
    3. Shortness of Breath
    4. Difficulty Breathing
    5. Muscle Pain
    6. Headache
    7. Sore Throat
    8. Chills
    9. New loss of taste or smell
    10. Congestion
    11. Runny nose
  2. Onset of symptoms occurred within the past 7 calendar days.

Asymptomatic Participants must meet BOTH of the following:

  1. Not experiencing any of the following symptoms at the time of specimen collection and testing: fever, cough, shortness of breath or difficulty breathing, new loss of taste or smell, muscle or body aches, headache, sore throat, congestion or runny nose, nausea or vomiting or diarrhea.
  2. Exposed to known COVID-19 positive individuals or are suspected to have had COVID-19 over the past 7 calendar days.

Exclusion Criteria:

Participants must not meet ANY of the following:

  1. Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection.
  2. Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months.
  3. Underwent a nasal wash / aspirate as part of standard of care < 24 hours prior to the study start.
  4. Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy.
  5. Previously participated in this study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Groups

Positives: Symptomatic vs. Asymptomatic Negatives: Symptomatic vs. Asymptomatic

Each broken down by age groups:

2-14 years old 15-24 years old 25-64 years old 65+ years old
Diagnostic test: Diagnostic Test: IN Vitro
In vitro diagnostic test for COVID-19 using anterior nasal swabs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.
Time Frame: 1-16 weeks
The primary endpoints of this study will be the correlation of the 3EO Health SARS-CoV-2 OTC At Home Test results from nasal samples to the comparator, standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample
1-16 weeks

Collaborators and Investigators

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

Sponsor

3EO Health

Investigators

  • Study Director: Adelina Paunescu, PhD, Medicept 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 11, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3EO-CoV2-02

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.

No

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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