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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12622000570785
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
13/04/2022
Date last updated
1/08/2022
Date data sharing statement initially provided
13/04/2022
Date results information initially provided
13/07/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
EuGeni COVID-19 (SARS-CoV-2) Antigen Rapid Diagnostic Test Clinical Performance Study in Victoria
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Scientific title
EuGeni COVID-19 (SARS-CoV-2) Antigen Rapid Diagnostic Test Clinical Performance Study in Victoria
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Secondary ID [1]
306684
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 antigen
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Condition category
Condition code
Infection
322981
322981
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Prospective nasal and throat swabs will be collected from consenting participants who have COVID-19 infection and also from participants who are likely to be healthy (will test negative) for COVID-19 infection.
Swabs will be tested on the trial IVD device to detect COVID-19 infection (SAR-CoV-2 antigen). Results from the trial device will be compared against standard of care reference PCR results.
The study design is as follows:
This study is a prospective clinical study using an in vitro diagnostic (IVD) rapid test called EuGeni SARS-CoV-2 Ag RDT and EuGeni Reader. The intervention required for this trial is the randomised collection of bilateral nasal anterior in arm A and a bilateral combined mid-turbinate and throat swab in arm B and standard of care mid-turbinate and throat swabs, which are then compared against a previously collected standard of care mid-turbinate and throat swabs (taken as part of local standard of care COVID-19 testing). Participants will be asked to provide consent, prior to the conduct of any study procedures.
Participant samples with a collection date and the number of days since onset of symptoms, if any, will be recorded. Participants that have received a COVID-19 positive result by RT-PCR or rapid antigen test (RAT), will be re-tested with EuGeni SARS-CoV-2 Ag RDT and EuGeni Reader, as well as RT-PCR. Both asymptomatic and symptomatic positive patients will be included. If symptomatic, the RDT test will be done within 7 days post onset of symptoms. Participants that have received a COVID-19 negative result by RT-PCR or RAT will be re-tested with the RDT and RT-PCR. For the trial component, two separate swab collections will be collected per participant, as follows:
Pilot:
Around 15 known positives and 10 negative participant anterior nasal for IVD testing and a combined nose and throat samples (for a second confirmatory PCR test) will be recruited and tested in a pilot arm of the study. This will assist in determining the feasibility of the study design. Upon successful completion of the pilot, Arm A will run, followed by Arm B.
Arm A:
All participants will provide two swabs as follows.
The first swab, for bilateral anterior anterior nasal sampling, will be tested by healthcare professionals using swabs provided in the EuGeni SARS-CoV-2 Ag RDT kit, as per the instructional product information.
The second swab will be taken from the bilateral mid-turbinate and throat, using a swab supplied by the Sponsor, placed into viral transport media (VTM) and then transported to the specified laboratory for RT-PCR testing, as per standard laboratory procedures.
Target number of trial-derived swab collections are:
a) 50100 RT-PCR confirmed COVID-19 positive nasal (nasal anterior anterior) swabs.
b) at least 50200 RT-PCR confirmed COVID-19 negative nasal (nasal anterior anterior) swabs.
Arm B:
All participants will provide two swabs as follows.
The first swab, for combined bilateral mid-turbinate and throat nasal sampling will be tested by healthcare professionals using swabs provided in the EuGeni SARS-CoV-2 Ag RDT kit, as per the instructional product information.
The second swab will be taken from the bilateral mid-turbinate and throat, using a swab supplied by the Sponsor, placed into viral transport media (VTM) and then transported to the specified laboratory for RT-PCR testing, as per standard laboratory procedures.
Target number of trial-derived swab collections are:
a) 50 RT-PCR confirmed COVID-19 positive nasal (combined bilateral mid-turbinate and throat) swabs.
b) at least 50 RT-PCR confirmed COVID-19 negative nasal (nasal anterior) swabs.
The above results will be validated by comparing captured research data against accredited COVID-19 RT-PCR standard of care data, which is obtained from electronic medical records, from the consenting participants.
Participants within the relevant arms will be educated on how to self-collect the respective samples of either bilateral anterior nasal, combined bilateral mid-turbinate and throat mid-turbinate and nasopharyngeal nose and throat standard of care PCR samples, under supervision by a research study team member.
Participant demographics and COVID-19 medical history will be collected as follows:
o Gender.
o Age at the time of intervention and year of birth.
o Race.
o COVID-19 vaccination, including name of the vaccine and number of doses.
o Any previous anti-viral medications.
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Intervention code [1]
323130
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Early detection / Screening
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Comparator / control treatment
Swabs will be tested on the trial IVD device to detect COVID-19 infection (SAR-CoV-2 antigen). Results from the trial device will be compared against (accredited laboratory) standard of care reference PCR results.
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Control group
Active
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Outcomes
Primary outcome [1]
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To assess the overall (composite) specificity and sensitivity of EuGeni SARS-CoV-2 Ag RDT assay using bilateral nasal swabs against data obtained from COVID-19 RT-PCR standard of care mid-turbinate and throat samples.
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Assessment method [1]
330750
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Timepoint [1]
330750
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Once 100 positive and 200 negative participant results have been obtained.
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Secondary outcome [1]
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Clinical performance of sensitivity and specificity produced across different viral loads and participant demographics. This will be assessed by comparing bilateral nasal swabs data against data obtained from COVID-19 RT-PCR standard of care mid-turbinate and throat samples.
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Assessment method [1]
407432
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Timepoint [1]
407432
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Once the primary timepoint has been reached
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Eligibility
Key inclusion criteria
Inclusion Criteria: (participants must meet ‘Yes’ for all)
• The participant is 18 years or older and capable to provide informed consent.
• The participant is eligible regardless of whether they have previously received a COVID-19 vaccine.
• The participant is eligible regardless of whether antiviral medication has been taken.
For Positive patients:
o The participant has previously confirmed positive for COVID-19 RT-PCR or RAT test result within 7 days.
o The participant is either symptomatic and within 7 days post onset of symptoms (according to local state guidelines) or is asymptomatic and within 7 days post COVID-19 RT-PCR or RAT confirmed results (time of the test is the time that the swab was collected) or
close contact to an individual who has been confirmed COVID-19 positive. (Note: Home COVID-19 tests cannot be used to determine a positive COVID19 result).
For Negative patients:
o The participant has recently tested negative (off study) by RT-PCR or RAT, or is likely to test negative.
for COVID-19 and they are not displaying symptoms for COVID-19. o The participant last tested negative for COVID-19 five weeks or more from the time of re-consenting to joining the study to donate samples.
(Note: A maximum of 25% of the Negative participant collections can be selected under this criteria)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria: (Participants must meet ‘No’ for all)
• Under 18 years old.
• The participant has declined to participate in the study.
• The participant is deemed clinically unsuitable by a treating physician or the Principal Investigator.
• The participant is incapable of providing informed consent.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/01/2022
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Date of last participant enrolment
Anticipated
15/04/2022
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Actual
31/05/2022
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Date of last data collection
Anticipated
15/04/2022
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Actual
1/06/2022
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Sample size
Target
300
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Accrual to date
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Final
226
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
21967
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
37063
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
311017
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Commercial sector/Industry
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Name [1]
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Anteotech Ltd
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Address [1]
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26 Brandl Street
Eight Mile Plains
QLD 4113
Australia
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Country [1]
311017
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Anteotech Ltd
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Address
26 Brandl Street
Eight Mile Plains
QLD 4113
Australia
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Country
Australia
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Secondary sponsor category [1]
312354
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None
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Name [1]
312354
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Address [1]
312354
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Country [1]
312354
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310563
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
310563
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Alfred Hospital Ethics Committee
Alfred Health
55 Commercial Rd, Melbourne VIC 3004
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Ethics committee country [1]
310563
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Australia
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Date submitted for ethics approval [1]
310563
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Approval date [1]
310563
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29/12/2021
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Ethics approval number [1]
310563
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Summary
Brief summary
The objective of the study is to evaluate performance of nasal and throat samples tested using the trial device EuGeni SARS-CoV-2 Ag RDT against standard of care PCR.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr James McMahon
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Address
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The Alfred
55 Commercial Rd, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 907 66908
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Fax
118098
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Email
118098
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[email protected]
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Contact person for public queries
Name
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Ms Anna Coldham
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Address
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The Alfred
55 Commercial Rd, Melbourne VIC 3004
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Country
118099
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Australia
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Phone
118099
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+61 3 907 66908
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Fax
118099
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Email
118099
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[email protected]
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Contact person for scientific queries
Name
118100
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Ms Anna Coldham
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Address
118100
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The Alfred
55 Commercial Rd, Melbourne VIC 3004
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Country
118100
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Australia
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Phone
118100
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+61 3 907 66908
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Fax
118100
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Email
118100
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data will not offer benefit to participants or general public.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Diagnostic performance of the EuGeni SARS-CoV-2 Ag...
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