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Trial registered on ANZCTR


Registration number
ACTRN12621000907842
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
13/07/2021
Date last updated
25/03/2022
Date data sharing statement initially provided
13/07/2021
Date results provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Orbis Quantitative Immunity for COVID-19 Test in Healthy Airline Staff to Confirm its Sensitivity and Specificity
Scientific title
A Phase I, Single-Site study to Test the Sensitivity and Specificity of the Orbis Quantitative Immunity for COVID-19 (QIC) Test in Detecting Levels of Anti-SARS-CoV2 IgG Antibodies in Vaccinated and Un-Vaccinated Airline Staff
Secondary ID [1] 304658 0
Nil Known
Universal Trial Number (UTN)
U1111-1267-3749
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 322610 0
Condition category
Condition code
Inflammatory and Immune System 320225 320225 0 0
Normal development and function of the immune system
Infection 320372 320372 0 0
Studies of infection and infectious agents
Respiratory 320373 320373 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional.

This is a Phase I, single-site study to test the sensitivity, specificity and reproducibility of the Orbis QIC Test in vaccinated and un-vaccinated participants.

The Orbis QIC test is being developed as a rapid tool to assess an individual’s immune response to COVID-19 from a single finger prick of blood. The information gathered from this study will be used to further develop the device with the aim that in future it can be used as a screening tool for COVID-19 immunity.

The study will involve participants individually attending one clinic visit of approximately 30 minutes during which the following procedures will take place:
- Informed consent process
- Collection of demographic information including age, gender and ethnicity
- Collection of COVID-19 vaccination status and date of vaccination, if applicable
- Collection of the date and result of the participants most recent PCR test
- Two Finger prick blood samples will be collected

The study will be run at the airline's facility with the support of a private research study team. All members of the study team are appropriately qualified by education, training and experience suitable to their role in the study. The Orbis Arca device on which the QIC Test is run will be operated by trained Orbis personnel.
Intervention code [1] 321017 0
Early detection / Screening
Comparator / control treatment
Confirmation of previous vaccination or no prior vaccination will serve as the references for the QIC Test results.
Control group
Active

Outcomes
Primary outcome [1] 328096 0
Diagnostic Sensitivity
- Measured by agreement with previous vaccination [measurement of IgG antibodies against COVID-19 infection by Orbis QIC Test compared to vaccination status].
Timepoint [1] 328096 0
Visit 1
Primary outcome [2] 328097 0
Diagnostic Specificity
- Measured by agreement with no evidence of previous vaccination [measurement of IgG antibodies against COVID-19 infection by Orbis QIC Test compared to vaccination status].
Timepoint [2] 328097 0
Visit 1
Secondary outcome [1] 397626 0
Reproducibility
- Assessed by the percentage variability of measurements of antibodies against COVID-19 infection between duplicate finger prick blood samples as measured using the Orbis QIC Test.
Timepoint [1] 397626 0
Visit 1 - 2 finger prick blood samples will be collected

Eligibility
Key inclusion criteria
1. Male or female airline staff, 18-65 (inclusive) years of age.
2. Is in generally good health with no underlying conditions that would be considered to present a risk to the participant or data integrity.
3. For vaccinated airline staff, the participant:
- Is able to provide documentation of being fully vaccinated for SARS-CoV-2 infection at least 7 days prior to Day 1.
- Received the Pfizer-BioNTech COVID-19 vaccine through the New Zealand vaccination pregame
4. Is willing to provide consent to participate in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
2. Currently being treated for or are known to be not completely free of symptoms associated with SARS-CoV-2 infection.
3. Known to be pregnant.
4. Partially vaccinated person (i.e. having received only one of the two vaccine doses)
5. For un-vaccinated participants, no previous confirmed or suspected SARS-CoV-2 infection, as determined by positive PCR, antigen, or antibody test, or by the determination of a government health agency.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
175 participants (100 vaccinated and 75 non-vaccinated) will be recruited. The sample size for vaccinated participants has been estimated to provide 80% power to satisfy the following performance specifications:
- Sensitivity >=87%, lower 95% confidence limit (2-sided) >74.4%
The sample size for unvaccinated participants is the recommended minimum number according to FDA guidelines, where specific power calculations are not required.
As a secondary aim for unvaccinated participants is the reproducibility of the assay, the number of vaccinated participants is higher than the minimum defined in the FDA guidance document (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised),” ) to facilitate the investigation of reproducibility.
For reproducibility, duplicate samples from all vaccinated participants and 8 (approximately 10%) of unvaccinated participants will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/09/2021
Actual
5/10/2021
Date of last participant enrolment
Anticipated
29/10/2021
Actual
15/10/2021
Date of last data collection
Anticipated
29/10/2021
Actual
12/11/2021
Sample size
Target
175
Accrual to date
Final
176
Recruitment outside Australia
Country [1] 23931 0
New Zealand
State/province [1] 23931 0
Auckland

Funding & Sponsors
Funding source category [1] 309025 0
Commercial sector/Industry
Name [1] 309025 0
Orbis Diagnostics Limited
Country [1] 309025 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Orbis Diagnostics Limited
Address
55 Shortland Street
Auckland CBD
1010
Country
New Zealand
Secondary sponsor category [1] 309960 0
None
Name [1] 309960 0
Address [1] 309960 0
Country [1] 309960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308906 0
Health and Disability Ethics Committees
Ethics committee address [1] 308906 0
Ethics committee country [1] 308906 0
New Zealand
Date submitted for ethics approval [1] 308906 0
16/07/2021
Approval date [1] 308906 0
20/08/2021
Ethics approval number [1] 308906 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112294 0
Dr Api Talemaitoga
Address 112294 0
Southern Clinical Trials Manukau
175 Cavendish Drive
Manukau
Auckland
2104
Country 112294 0
New Zealand
Phone 112294 0
+64 21 220 8269
Fax 112294 0
Email 112294 0
[email protected]
Contact person for public queries
Name 112295 0
Api Talemaitoga
Address 112295 0
Southern Clinical Trials Manukau
175 Cavendish Drive
Manukau
Auckland
2104
Country 112295 0
New Zealand
Phone 112295 0
+64 21 220 8269
Fax 112295 0
Email 112295 0
[email protected]
Contact person for scientific queries
Name 112296 0
Api Talemaitoga
Address 112296 0
Southern Clinical Trials Manukau
175 Cavendish Drive
Manukau
Auckland
2104
Country 112296 0
New Zealand
Phone 112296 0
+64 21 220 8269
Fax 112296 0
Email 112296 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.