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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
Scientific title
EuGeni COVID-19 (SARS-CoV-2) Antigen Rapid Diagnostic Test Clinical Performance Study in Victoria
Secondary ID [1] 306684 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 antigen 325623 0
Condition category
Condition code
Infection 322981 322981 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323130 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 330750 0
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.
Timepoint [1] 330750 0
Once 100 positive and 200 negative participant results have been obtained.
Secondary outcome [1] 407432 0
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.
Timepoint [1] 407432 0
Once the primary timepoint has been reached

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/01/2022
Date of last participant enrolment
Anticipated
15/04/2022
Actual
31/05/2022
Date of last data collection
Anticipated
15/04/2022
Actual
1/06/2022
Sample size
Target
300
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21967 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 37063 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 311017 0
Commercial sector/Industry
Name [1] 311017 0
Anteotech Ltd
Country [1] 311017 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Anteotech Ltd
Address
26 Brandl Street
Eight Mile Plains
QLD 4113
Australia
Country
Australia
Secondary sponsor category [1] 312354 0
None
Name [1] 312354 0
Address [1] 312354 0
Country [1] 312354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310563 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 310563 0
Alfred Hospital Ethics Committee
Alfred Health
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 310563 0
Australia
Date submitted for ethics approval [1] 310563 0
Approval date [1] 310563 0
29/12/2021
Ethics approval number [1] 310563 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118098 0
Dr James McMahon
Address 118098 0
The Alfred
55 Commercial Rd, Melbourne VIC 3004
Country 118098 0
Australia
Phone 118098 0
+61 3 907 66908
Fax 118098 0
Email 118098 0
[email protected]
Contact person for public queries
Name 118099 0
Anna Coldham
Address 118099 0
The Alfred
55 Commercial Rd, Melbourne VIC 3004
Country 118099 0
Australia
Phone 118099 0
+61 3 907 66908
Fax 118099 0
Email 118099 0
[email protected]
Contact person for scientific queries
Name 118100 0
Anna Coldham
Address 118100 0
The Alfred
55 Commercial Rd, Melbourne VIC 3004
Country 118100 0
Australia
Phone 118100 0
+61 3 907 66908
Fax 118100 0
Email 118100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not offer benefit to participants or general public.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Diagnostic performance of the EuGeni SARS-CoV-2 Ag... [More Details]

Documents added automatically
No additional documents have been identified.