Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000996864
Ethics application status
Approved
Date submitted
15/07/2021
Date registered
28/07/2021
Date last updated
28/04/2024
Date data sharing statement initially provided
28/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
COVID-19 ANTibody And T-cell Assays
Scientific title
A research study to develop new diagnostic tests to detect antibody and viral antigens for COVID-19 to identify those who may be immune and less likely to infect others.
Secondary ID [1] 304481 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The CANTATA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 322316 0
Condition category
Condition code
Infection 319987 319987 0 0
Other infectious diseases
Respiratory 320479 320479 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants aged over 18 years entering New Zealand, or working at the borders and those who have had COVID-19 will be asked to provide blood and saliva sample at yearly intervals over a 3 year period. They will also be asked to complete a 10 minute health questionnaire and consent to follow of of their health by direct contact and remote access through the Ministry of Health, GP, District Health Board, Laboratory, Pharmaceutical, Births and Death & Marriages administrative records
Intervention code [1] 320834 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327861 0
SARS-COV-2 Antibody prevalence assessed by blood sample
Timepoint [1] 327861 0
At baseline
Primary outcome [2] 327862 0
SARS-COV-2 active T-cell prevalence assessed by blood sample
Timepoint [2] 327862 0
At baseline
Primary outcome [3] 327863 0
Diagnosis of a cardiac condition as determined from data linkage to medical records
Timepoint [3] 327863 0
2 years after baseline sampling
Secondary outcome [1] 396801 0
Duration of COVID-19 symptoms as assessed by medical history questionnaire
Timepoint [1] 396801 0
2 years after baseline sampling

Eligibility
Key inclusion criteria
Any person 18 years of age or older who has had 1) clinically verified COVID 19, 2) suspected of being exposed to SARS-COV-2, 3) close or casual associates of 1) or 2) and those coming into New Zealand via the quarantine and isolation facilities along with staff working at the borders or in health facilities will be invited to take part in this observational study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling to provide signed informed consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be entered into a dedicated database (STARLIMS, Abbott Informatics) throughout the conduct of the study, and extracted in a de-identified format to SPSS for statistical analysis. Levels of biomarkers and clinical indices will be assessed for normal distribution and, if appropriate, log-transformed to validate parametric analyses including t-tests. P<0.05 will be accepted as indicating significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/06/2021
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
3000
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 23781 0
New Zealand
State/province [1] 23781 0

Funding & Sponsors
Funding source category [1] 308842 0
Government body
Name [1] 308842 0
Ministry of Business Innovation and Employment
Country [1] 308842 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street
North Dunedin
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 309758 0
None
Name [1] 309758 0
Address [1] 309758 0
Country [1] 309758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308749 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308749 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 308749 0
New Zealand
Date submitted for ethics approval [1] 308749 0
17/12/2020
Approval date [1] 308749 0
10/05/2021
Ethics approval number [1] 308749 0
21/STH/12

Summary
Brief summary
We will recruit up to 3000 participants including ideally 200-300 clinically proven COVID cases to assess 1) Antibody prevalence, performance and responses 2) active T-cell prevalence, responses and types 3) cardiac outcomes over the next 3 years in proven COVID cases versus “others”. Event rates will be obtained through Ministry of Health, GP, DHB, Birth Death & Marriages and phone or email follow up with participants. This will provide a biobank to draw upon for future investigator inspired work.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111758 0
Prof Chris Pemberton
Address 111758 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Central 8011
Country 111758 0
New Zealand
Phone 111758 0
+643 33640887
Fax 111758 0
+643 364 1115
Email 111758 0
[email protected]
Contact person for public queries
Name 111759 0
Prof Chris Pemberton
Address 111759 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Central 8011
Country 111759 0
New Zealand
Phone 111759 0
+643 33640887
Fax 111759 0
+643 364 1115
Email 111759 0
[email protected]
Contact person for scientific queries
Name 111760 0
Prof Chris Pemberton
Address 111760 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Central 8011
Country 111760 0
New Zealand
Phone 111760 0
+643 33640887
Fax 111760 0
+643 364 1115
Email 111760 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
there is a no plan to make individual participant data (IPD) publicly available for this study


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.