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COVID-19 Molecular OTC At Home Test

Primary Purpose

COVID-19 Pandemic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Test: IN Vitro
Sponsored by
3EO Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19 Pandemic

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

All Participants must meet ALL of the following: ≥ 2 years of age. Subjects ages 2 ≤ x ≤ 17 will provide assent in addition to parent / legal guardian's consent. Able to read and write in English and/or Spanish (subjects or guardians) 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: Have at least one of the following symptoms the day of the test: Fever Cough Shortness of Breath Difficulty Breathing Muscle Pain Headache Sore Throat Chills New loss of taste or smell Congestion Runny nose Onset of symptoms occurred within the past 7 calendar days. Asymptomatic Participants must meet BOTH of the following: 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. 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: Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection. Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months. Underwent a nasal wash / aspirate as part of standard of care < 24 hours prior to the study start. Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy. Previously participated in this study.

Sites / Locations

  • Bright Research Center
  • I.V.A.M. Clinical & Investigational Center
  • Vytalus Medical Atascocita
  • Vytalus Medical

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Groups

Arm Description

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

Outcomes

Primary Outcome Measures

Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.
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

Secondary Outcome Measures

Full Information

First Posted
January 20, 2023
Last Updated
September 25, 2023
Sponsor
3EO Health
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1. Study Identification

Unique Protocol Identification Number
NCT05704803
Brief Title
COVID-19 Molecular OTC At Home Test
Official Title
Prospective, Multi-Center, Non-Randomized Study to Evaluate OTC At Home SARS-CoV-2 Molecular Diagnostic Test
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3EO Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Groups
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic Test: IN Vitro
Intervention Description
In vitro diagnostic test for COVID-19 using anterior nasal swabs.
Primary Outcome Measure Information:
Title
Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.
Description
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
Time Frame
1-16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
All Participants must meet ALL of the following: ≥ 2 years of age. Subjects ages 2 ≤ x ≤ 17 will provide assent in addition to parent / legal guardian's consent. Able to read and write in English and/or Spanish (subjects or guardians) 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: Have at least one of the following symptoms the day of the test: Fever Cough Shortness of Breath Difficulty Breathing Muscle Pain Headache Sore Throat Chills New loss of taste or smell Congestion Runny nose Onset of symptoms occurred within the past 7 calendar days. Asymptomatic Participants must meet BOTH of the following: 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. 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: Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection. Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months. Underwent a nasal wash / aspirate as part of standard of care < 24 hours prior to the study start. Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy. Previously participated in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelina Paunescu, PhD
Organizational Affiliation
Medicept Inc
Official's Role
Study Director
Facility Information:
Facility Name
Bright Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
I.V.A.M. Clinical & Investigational Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Vytalus Medical Atascocita
City
Humble
State/Province
Texas
ZIP/Postal Code
77346
Country
United States
Facility Name
Vytalus Medical
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COVID-19 Molecular OTC At Home Test

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