SARS-CoV-2CGI-EPM-IXNCT05281692
Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices ( CGI-EPM-IX )
An observational study of SARS-CoV-2, run by Convergent Genomics, Inc. at 1 site in United States.
Trial summary
This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Enhanced Preservation Media (EPM-IX)
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 21 Mar 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female subjects ≥ 18 years of age who are being tested for COVID-19
Who may be able to join
- Subject must be ≥18 years of age
- Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit
- Subject must be able to understand and willingly provide informed consent
Who cannot join
- Cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices
This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)
Read the detailed description
This is a minimal risk study where patients at UroPartners Urology Group will consent to SARS-CoV-2 nasopharyngeal swab testing using both, a standard of care test with standard Viral Transport Medium and a second test using Convergent Genomics' proprietary Enhanced Preservation Media (EPM-IX). Subjects will self-swab each nostril during their medical appointment at UroPartners. UroPartners designated staff with then send the collection kits out for testing. Clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. All of these data points will be anonymized.
- Conditions
- SARS-CoV-2
- Being tested
- Enhanced Preservation Media (EPM-IX)
- Keywords
- EPM-IX, Covid-19, SARS-CoV-2, Nasopharyngeal swab, Med Schenker's STM viral media
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Preservation Media (EPM-IX)Diagnostic test
EPM-IX is a clinical specimen collection medium that inactivates pathogens, preserves nucleic acids, and integrates DNA/RNA purification. EPM-IX eliminates the need for additional extraction reagents or kits and purifies DNA/ RNA from the entire sample to enable optimal test performance.
| Study group | Role | What they receive |
|---|---|---|
| Positive | Enhanced Preservation Media (EPM-IX) Receives: Diagnostic Test: Enhanced Preservation Media (EPM-IX) | |
| Control | Med Schenker's STM viral media Receives: Diagnostic Test: Enhanced Preservation Media (EPM-IX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Diagnostic Performance
Comparison of diagnostic performances (sensitivity, specificity, and predictive values) of EPM-IX vs Med Schenker's STM viral media with detection of SARS-CoV-2 infection.
Measured: At the time of inclusion
Secondary outcomes (3)
Comparison of Lab Processing
Comparison of Lab processing time with accessioning and processing of an EPM-IX tube compared to with Med Schenker's STM viral media
Measured: At the time of inclusion
Quantitative PCR CT-values
Quantitative PCR CT-values (of internal control and target gene levels) using EPM-IX vs Med Schenker's STM viral media
Measured: At the time of inclusion
Difference in case rate or detection of viral load samples observed
Difference in case rate or detection of viral load samples observed between EPM-IX and Med Schenker's STM viral media
Measured: At the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start2 Feb 2022
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Convergent Genomics, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Paul Yonover, MD, Principal investigator, UroPartners, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281692
- Sponsor's protocol ID
- CGI-EPM-IX
- Acronym
- CGI-EPM-IX
- Status last verified
- Oct 2022
- First submitted
- 7 Mar 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Parallel Assignment and Single Site Comparison of EPM-IX to Currently Used Specimen Transportation and Extraction Devices
- ClinicalTrials.gov ID
- NCT05281692
- Acronym / sponsor ID
- CGI-EPM-IX / CGI-EPM-IX
- Conditions
- SARS-CoV-2
- Keywords
- EPM-IX, Covid-19, SARS-CoV-2, Nasopharyngeal swab, Med Schenker's STM viral media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Convergent Genomics, Inc.Research network
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 16 Mar 2022 (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.
This is a research study to evaluate the clinical utility of the Enhanced Preservation Media with Integrated Extraction (EPM-IX)
Detailed description
This is a minimal risk study where patients at UroPartners Urology Group will consent to SARS-CoV-2 nasopharyngeal swab testing using both, a standard of care test with standard Viral Transport Medium and a second test using Convergent Genomics' proprietary Enhanced Preservation Media (EPM-IX). Subjects will self-swab each nostril during their medical appointment at UroPartners. UroPartners designated staff with then send the collection kits out for testing. Clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. All of these data points will be anonymized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive | – | Diagnostic Test: Enhanced Preservation Media (EPM-IX)Enhanced Preservation Media (EPM-IX) |
| Control | – | Diagnostic Test: Enhanced Preservation Media (EPM-IX)Med Schenker's STM viral media |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects ≥ 18 years of age who are being tested for COVID-19
Key inclusion criteria (3 listed)
- Subject must be ≥18 years of age
- Subject is a current patient at UroPartners and is willing to be tested for Covid- 19 during a routine visit
- Subject must be able to understand and willingly provide informed consent
Key exclusion criteria (1 listed)
- Cannot provide informed consent
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 |
|---|---|---|
| Enhanced Preservation Media (EPM-IX)EPM-IX is a clinical specimen collection medium that inactivates pathogens, preserves nucleic acids, and integrates DNA/RNA purification. EPM-IX eliminates the need for additional extraction reagents or kits and purifies DNA/ RNA from the entire sample to enable optimal test performance. | Diagnostic test | Control, Positive |
Primary outcome
Comparison of Diagnostic Performance
Time frame: At the time of inclusion
Comparison of diagnostic performances (sensitivity, specificity, and predictive values) of EPM-IX vs Med Schenker's STM viral media with detection of SARS-CoV-2 infection.
3 secondary outcomes
Comparison of Lab Processing
Time frame: At the time of inclusion
Quantitative PCR CT-values
Time frame: At the time of inclusion
Difference in case rate or detection of viral load samples observed
Time frame: At the time of inclusion
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 18 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Paul Yonover, MD principal investigator
UroPartners, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by Convergent Genomics, Inc. at 1 site 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 3 inclusion and 1 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Comparison of Diagnostic Performance (time frame: At the time of inclusion). 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 18 Oct 2022.