Covid19NCT04981769
POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
An observational study of Covid19, run by Anavasi Diagnostics.
Trial summary
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites. Read more about this study
- Who is it for?
- Ages 2 to 125 years
- Conditions the study is for
- Covid19
- What is being tested?
- Covid-19 test
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 2 Aug 2021to 30 Nov 2021
- 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 2 to 125 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All eligible subjects presenting to clinical site for Covid-19 testing
Who may be able to join
- Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.
Who cannot join
- Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing
Trial locations and contacts
No sites are listed yet.
About this study
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.
Read the detailed description
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.
- Conditions
- Covid19
- Being tested
- Covid-19 test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 testDiagnostic test
PCR Covid-19 test
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients presenting to clinical sites for Covid-19 testing who are 2 years of age or older. Receives: Diagnostic Test: Covid-19 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 PCR test result
Molecular Covid-19 testing
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start2 Aug 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anavasi Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981769
- Sponsor's protocol ID
- 003
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
- ClinicalTrials.gov ID
- NCT04981769
- Acronym / sponsor ID
- 003
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Anavasi DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 29 Jul 2021 (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.
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.
Detailed description
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Covid-19 testPatients presenting to clinical sites for Covid-19 testing who are 2 years of age or older. |
Who may qualify
- Ages
- 2 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible subjects presenting to clinical site for Covid-19 testing
Key inclusion criteria (1 listed)
- Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.
Key exclusion criteria (1 listed)
- Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing
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 |
|---|---|---|
| Covid-19 testPCR Covid-19 test | Diagnostic test | Patients |
Primary outcome
Covid-19 PCR test result
Time frame: 90 minutes
Molecular Covid-19 testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Anavasi Diagnostics.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Blaivas, MD (770-205-7721, mike.blaivas@anavasidx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid-19 PCR test result (time frame: 90 minutes). 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 29 Jul 2021.