COVID-19 Molecular OTC At Home Test

NCT05704803 | Completed FDA Device

• 1 other identifier: 3EO-CoV2-02
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

• 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

  1-16 weeks

Study Arms (1)

Study Groups

EXPERIMENTAL

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

Interventions

Diagnostic Test: IN Vitro DIAGNOSTIC_TEST

In vitro diagnostic test for COVID-19 using anterior nasal swabs.

Study Groups

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3EO Health: lead

Study Sites (4)

Bright Research Center

Miami, Florida, 33144, United States

Location

I.V.A.M. Clinical & Investigational Center

Miami, Florida, 33144, United States

Location

Vytalus Medical Atascocita

Humble, Texas, 77346, United States

Location

Vytalus Medical

Kingwood, Texas, 77339, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Adelina Paunescu, PhD

  Medicept Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: April 11, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)