COVID-19 Molecular OTC At Home Test

Not Applicable

Completed

• Conditions: COVID-19 Pandemic

• Registration Number: NCT05704803
• Lead Sponsor: 3EO Health

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.

Study Timeline

• Study Start: 2022-04-11
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-30
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (4)

Vytalus Medical; 🇺🇸 Kingwood, Texas, United States

Bright Research Center; 🇺🇸 Miami, Florida, United States

I.V.A.M. Clinical & Investigational Center; 🇺🇸 Miami, Florida, United States

Vytalus Medical Atascocita; 🇺🇸 Humble, Texas, United States