Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001519842p
Ethics application status
Submitted, not yet approved
Date submitted
30/10/2021
Date registered
9/11/2021
Date last updated
9/11/2021
Date data sharing statement initially provided
9/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Herekorenga - Freedom Study - Understanding COVID-19 antibody levels to help open up Aotearoa New Zealand
Scientific title
Using the PictArray™ SARS-CoV-2 IgG ELISA Test to better understand COVID-19 antibody levels within the Aotearoa New Zealand population.
Secondary ID [1] 305661 0
Protocol Number: Val P - 002
Universal Trial Number (UTN)
U1111-1271-1213
Trial acronym
PCNZT21
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 324165 0
Condition category
Condition code
Infection 321638 321638 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to attend the designated Tend Medical Clinic (in Auckland) at a pre-arranged time, where all documentation such as the questionnaire and PISCF will be reviewed. If there are any further questions these can be answered at this point in time. Once the participant is happy to continue the process a medical professional will obtain a saliva sample, and a blood sample of approximately 20 mL, for analysis in the study. This will be the only time a sample from participants will be taken for this study. It is estimated participants will require 20 - 30 minutes to complete documentation and sample collection.
These samples will each be deidentified by being given a Pictor study participant code before being taken to the IGENZ laboratory for processing and analysis of the samples on the PictArray™ SARS-CoV-2 IgG Enzyme linked immunosorbent assay (ELISA) . This allows the analysis to be conducted under blinded study conditions. Pictor will then receive the data from the samples for further statistical analysis. A report detailing the presence or absence of antibodies towards the COVID-19 virus spike and nucleocapsid proteins will be compiled using this analysis.
Intervention code [1] 322082 0
Early detection / Screening
Comparator / control treatment
Naïve (no previous infection or vaccination) or pre-pandemic samples (if required) will be used as the control in this study.
If used pre-pandemic samples will be obtained from the NZ blood bank, and will have been collected prior to November 2019
Control group
Active

Outcomes
Primary outcome [1] 329405 0
This clinical trial would assess the Spike protein (SP) and Nucleocapsid protein (NP) ratio in serum found in different populations : naïve, previously infected individuals and vaccinated individuals by PictArray™ SARS-CoV-2 IgG ELISA.
Timepoint [1] 329405 0
Once only - on the day of enrolment at the Tend Medical Clinic
Secondary outcome [1] 402644 0
The development of a risk score based on the results of the PictArray™ SARS-CoV-2 IgG ELISA SP and NP ratio's.
Timepoint [1] 402644 0
Once only - on the day of enrolment at the Tend Medical Clinic

Eligibility
Key inclusion criteria
Participation by people of all genders, ages and ethnicities is encouraged in this study. Pictor would like to get a representative
selection of Aotearoa New Zealand’s unique population.
We are especially encouraging people who fall into the following categories to become involved in this study.
I. People who have been infected with COVID-19
II. People who have been vaccinated (one (1) or two (2) doses)
III. People who have not been infected with COVID-19 and have not been vaccinated
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
I. Participant has not given consent to use of their sample
II. The sample was not properly collected, labelled, transported, processed or stored according to instructions provided by Pictor to
the independent laboratory.

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
Other
Other design features
Participants will be categorised into three (3) main groups for sample data analysis based on information given in the participant
questionnaire:
I. People who have been infected with COVID-19
II. People who have been vaccinated (one (1) or two (2) doses)
III. People who have not been infected with COVID-19 and have not been vaccinated
Participants will all provide a saliva and blood sample for testing regardless of the above categories.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2021
Actual
Date of last participant enrolment
Anticipated
17/12/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 24259 0
New Zealand
State/province [1] 24259 0
Auckland

Funding & Sponsors
Funding source category [1] 310020 0
Government body
Name [1] 310020 0
Government body and company - MBIE - Ministry of Business, Innovation and Employment: COVID Innovation Acceleration fund
Country [1] 310020 0
New Zealand
Funding source category [2] 310058 0
Commercial sector/Industry
Name [2] 310058 0
Pictor
Country [2] 310058 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Pictor
Address
40 Kenwyn street, Parnell, Auckland 1052, NZ
Country
New Zealand
Secondary sponsor category [1] 311108 0
None
Name [1] 311108 0
Address [1] 311108 0
Country [1] 311108 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309727 0
Health and Disability Ethics Committees - Northern B
Ethics committee address [1] 309727 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 309727 0
New Zealand
Date submitted for ethics approval [1] 309727 0
21/10/2021
Approval date [1] 309727 0
Ethics approval number [1] 309727 0

Summary
Brief summary
The Herekorenga - Freedom study is recruiting approximately 300 participants to take part from a variety of different backgrounds.
Participants will be categorised into three (3) main groups for sample data analysis based on information given in the participant questionnaire:
I. People who have been infected with COVID-19
II. People who have been vaccinated (one (1) or two (2) doses)
III. People who have not been infected with COVID-19 and have not been vaccinated
Participants will be required to attend the designated Tend Medical Clinical at a pre-arranged time, where all documentation such as the questionnaire and consent form will be reviewed. If there are any further questions these can be answered at this point in time.
Once the participant is happy to continue the process a medical professional will obtain a saliva sample, and a blood sample of approximately 20 mL, for analysis in the study - a similar amount as a doctor would take during a routine blood test. This will be the
only time a sample will be required for this study.
These samples will each be deidentified by being given a Pictor study participant code before being taken to the IGENZ laboratory for processing and analysis. This allows the analysis to be conducted under blinded study conditions. IGENZ will also run the Rako
SARS-CoV-2 saliva test for each patient to ensure there are no unknown active infections.
Positive and negative controls will be included in each assay run. These controls will be run as separate samples alongside the patient samples. The PictArray™ SARS-CoV-2 IgG ELISA also includes internal controls (alignment spots) to monitor system performance during each run. Validity of each clinical sample will be determined by the result of both external and internal controls.
Trial website
https://pictordx.com/home/clinical-trials/
Trial related presentations / publications
Public notes
_Clinical Trials _clinicaltrials@pictordx.com_

Contacts
Principal investigator
Name 115186 0
Dr Natasha Gordon
Address 115186 0
Pictor:
40 Kenwyn street
Parnell
Auckland 1052
New Zealand
Country 115186 0
New Zealand
Phone 115186 0
+64 27 351 3280
Fax 115186 0
Email 115186 0
n.gordon@pictordx.com
Contact person for public queries
Name 115187 0
Mrs Gillian Moore
Address 115187 0
Pictor:
40 Kenwyn street
Parnell
Auckland 1052
New Zealand
Country 115187 0
New Zealand
Phone 115187 0
+64 21 891 728
Fax 115187 0
Email 115187 0
clinicaltrials@pictordx.com
Contact person for scientific queries
Name 115188 0
Dr Natasha Gordon
Address 115188 0
Pictor:
40 Kenwyn street
Parnell
Auckland 1052
New Zealand
Country 115188 0
New Zealand
Phone 115188 0
+64 27 3513280
Fax 115188 0
Email 115188 0
n.gordon@pictordx.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be made publicly available in this study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13869Study protocol  clinicaltrials@pictordx.com
13872Other    Participant questionnaire 383032-(Uploaded-30-10-2021-06-21-48)-Study-related document.pdf
13937Ethical approval    Once approved with will be available via a link.



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.