COVID-19 PandemicNCT05704803
COVID-19 Molecular OTC At Home Test
A study testing Diagnostic Test: IN Vitro in people with COVID-19 Pandemic, run by 3EO Health at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Diagnostic Test: IN Vitro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Apr 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Vytalus Medical Atascocita
Humble, Texas, 77346
Vytalus Medical
Kingwood, Texas, 77339
Bright Research Center
Miami, Florida, 33144
I.V.A.M. Clinical & Investigational Center
Miami, Florida, 33144
About this study
Official title: Prospective, Multi-Center, Non-Randomized Study to Evaluate OTC At Home SARS-CoV-2 Molecular Diagnostic Test
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.
Read the 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.
- Conditions
- COVID-19 Pandemic
- Being tested
- Diagnostic Test: IN Vitro
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: IN VitroDiagnostic test
In vitro diagnostic test for COVID-19 using anterior nasal swabs.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Diagnostic Test: IN Vitro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start11 Apr 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3EO Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adelina Paunescu, PhD, Study director, Medicept Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704803
- Sponsor's protocol ID
- 3EO-CoV2-02
- Status last verified
- Sep 2023
- First submitted
- 20 Jan 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Non-Randomized Study to Evaluate OTC At Home SARS-CoV-2 Molecular Diagnostic Test
- ClinicalTrials.gov ID
- NCT05704803
- Acronym / sponsor ID
- 3EO-CoV2-02
- Conditions
- COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- 3EO HealthIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Groups | Experimental | Diagnostic Test: Diagnostic Test: IN VitroPositives: 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: IN VitroIn vitro diagnostic test for COVID-19 using anterior nasal swabs. | Diagnostic test | Study Groups |
Primary outcome
Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adelina Paunescu, PhD study director
Medicept Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: IN Vitro in people with COVID-19 Pandemic, run by 3EO Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample. (time frame: 1-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.