MedTrace Logo

COVID-19 Molecular OTC At Home Test

NCT05704803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Diagnostic Test: IN Vitro

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

Sponsors & Collaborators

  • 3EO Health

    lead INDUSTRY

Principal Investigators

  • Adelina Paunescu, PhD · Medicept Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05704803 on ClinicalTrials.gov