SARS-CoV-2 OTC At Home Test
Primary Purpose
COVID-19 Pandemic
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In Vitro
Sponsored by
About this trial
This is an interventional diagnostic trial for COVID-19 Pandemic
Eligibility Criteria
Inclusion Criteria:
- Individuals suspected of COVID-19 disease by a healthcare provider or individuals who have tested positive within the past 7 calendar days with a confirmed positive COVID-19 test
- Individuals able to self-administer the investigational test either upon themselves or upon their child (under sixteen (16) years of age) as a parent or guardian
- Individuals willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Exclusion Criteria:
- If symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite)
- Unable to provide consent or obtain consent from a LAR
- Unwilling or unable to collect all sample types
- Enrolled in a study to evaluate an investigational drug
- Eating/drinking/smoking 30 minutes prior to specimen collection
- Prisoner or under incarceration
- Have contraindications to the collection of nasal specimens from the nares/nostrils, such as but not limited to nasal ulcers or nasal surgery within 3 months prior to sample collection
Sites / Locations
- Sarkis Clinical Trials
- I.V.A.M. Clinical & Investigational Center
- Sunrise Research Institute
- 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
1. Study Identification
Unique Protocol Identification Number
NCT05553964
Brief Title
SARS-CoV-2 OTC At Home Test
Official Title
Prospective, Multi-Center, Non-Randomized Study to Evaluate the 3EO Health SARS-CoV-2 Molecular Diagnostic Test
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Further usability assessment needed.
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
November 18, 2022 (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 3EO Health COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the 3EO Health COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the manufacturer (e.g., AN [anterior nares] swab) to determine accuracy of the 3EO Health COVID-19 Test in detecting COVID-19 in participants.
Detailed Description
3EO Health, Inc. has developed the 3EO Health COVID-19 Test, a unique rapid molecular test system, to detect SARS-CoV-2 virus in the OTC setting using a dedicated test reader "3EO Cube" to test nasal swab samples. Early testing will help to determine limit of detection (LOD) of the 3EO Health COVID-19 Test and will be compared to a sensitive molecular test that has been authorized for emergency use by the FDA. The 3EO Health COVID-19 Test will leverage the processing and testing of the 3EO Health Swab device when inserted directly into the reaction tube (3EO 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 3EO Health Cube 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
64 (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)
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
Inclusion Criteria:
Individuals suspected of COVID-19 disease by a healthcare provider or individuals who have tested positive within the past 7 calendar days with a confirmed positive COVID-19 test
Individuals able to self-administer the investigational test either upon themselves or upon their child (under sixteen (16) years of age) as a parent or guardian
Individuals willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Exclusion Criteria:
If symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite)
Unable to provide consent or obtain consent from a LAR
Unwilling or unable to collect all sample types
Enrolled in a study to evaluate an investigational drug
Eating/drinking/smoking 30 minutes prior to specimen collection
Prisoner or under incarceration
Have contraindications to the collection of nasal specimens from the nares/nostrils, such as but not limited to nasal ulcers or nasal surgery within 3 months prior to sample collection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerika Acosta
Organizational Affiliation
Medicept Inc
Official's Role
Study Director
Facility Information:
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
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
Sunrise Research Institute
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33325
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
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SARS-CoV-2 OTC At Home Test
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