Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000810617
Ethics application status
Approved
Date submitted
11/07/2023
Date registered
27/07/2023
Date last updated
27/07/2023
Date data sharing statement initially provided
27/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of health complications arising 12 months after a PCR-positive test for COVID-19 or influenza, and a negative PCR test for these illnesses.
Scientific title
A retrospective analysis of existing epidemiological data that compares health complications arising 12 months after a PCR-positive test for COVID-19 or influenza, and a negative PCR test for these illnesses.
Secondary ID [1] 310103 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 330667 0
Influenza 330668 0
Condition category
Condition code
Public Health 327481 327481 0 0
Health service research
Infection 327482 327482 0 0
Studies of infection and infectious agents
Respiratory 327483 327483 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
Eligible participants are those who received a PCR-positive test result for either COVID-19 or influenza from 1 July 2017. Participants who tested positive to both are excluded. Not all participants were tested for both illnesses simultaneously, meaning that COVID-19 positive cases are included if they were not also tested for influenza (and vice-versa), however these are small in number.

For patients with a record of a positive or negative via PCR test to COVID-19 in Qld's Notifiable Conditions System to 30 June 2023, they will be observed for 12 months after this test to determine whether they experience a subsequent health event demonstrated by being assigned an ICD-10 code/s (specific codes are listed in the protocol).

For patients with a record of a positive via PCR test to influenza in Qld's Notifiable Conditions System to 30 June 2023, they will be observed for 12 months after this test to determine whether they experience a subsequent health event demonstrated by being assigned an ICD-10 code/s (specific codes are listed in the protocol).

As a result, there is no active participation, but rather analysis of medical records to ascertain impacts arising from exposure. This utilises the analysis of ICD-10 codes, with a full list provided in the attached study protocol.
Intervention code [1] 326500 0
Not applicable
Comparator / control treatment
The primary comparator (“unexposed”) is people who have tested PCR positive to influenza from 1 July 2017 to 30 June 2023. They will be observed for 12 months after this test to determine whether they experience a subsequent health event demonstrated by being assigned an ICD-10 code/s (specific codes are listed in the protocol).

People testing PCR negative to COVID-19 (and no record of positivity to influenza) from specimens collected from 1 January 2020 are included as a secondary comparator group (“unexposed”). Like the primary comparator group, they will be observed for 12 months after this test to determine whether they experience a subsequent health event demonstrated by being assigned an ICD-10 code/s (specific codes are listed in the protocol).

These records will be accessed via Queensland Health's Notifiable Conditions System, ICD-10 codes will be reviewed, with the full list of codes described in the attached research protocol.
Control group
Historical

Outcomes
Primary outcome [1] 335347 0
For people with a positive PCR result for COVID-19, evidence of a subsequent health complication/s represented by an ICD-10 code. For example, it will review health records for subsequent presentations with Type 2 diabetes mellitus (ICD-10 code E11), myocarditis (ICD-10 code I40-41), and malaise and fatigue (ICD-10 code R53).
Timepoint [1] 335347 0
Within 12 months from PCR test result.
Primary outcome [2] 335348 0
For people with a positive PCR result for influenza, evidence of a subsequent health complication/s represented by an ICD-10 code. For example, it will review health records for subsequent presentations with Type 2 diabetes mellitus (ICD-10 code E11), myocarditis (ICD-10 code I40-41), and malaise and fatigue (ICD-10 code R53).
Timepoint [2] 335348 0
Within 12 months from PCR test result.
Primary outcome [3] 335349 0
For people with a negative PCR result for COVID-19 (and no record of positivity to influenza), evidence of a subsequent health complication/s represented by an ICD-10 code. For example, it will review health records for subsequent presentations with Type 2 diabetes mellitus (ICD-10 code E11), myocarditis (ICD-10 code I40-41), and malaise and fatigue (ICD-10 code R53).
Timepoint [3] 335349 0
Within 12 months from PCR test result.
Secondary outcome [1] 424029 0
Nil.
Timepoint [1] 424029 0
Nil.

Eligibility
Key inclusion criteria
People who had a PCR positive test result for COVID-19 or influenza which was recorded in the QLD Health Notifiable Conditions System.

People who had a PCR negative test result for COVID-19 which was recorded in the QLD Health Notifiable Conditions System.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
As an epidemiological study of the impacts of COVID-19 and influenza on the Queensland population, there are no proposed exclusions for those with a record of COVID-19 or influenza testing in NoCS from 1 July 2017 to 30 June 2023.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The number of participants will be determined by those who obtained a PCR test for COVID-19 or influenza between 1 July 2017 and 30 June 2023.

The primary exposure is defined as COVID-19 PCR test positive (“exposed”) or Influenza PCR test positive (“unexposed”)

Each case will be reviewed to determine if there has been a subsequent health complication within 12 months from this PCR test, as evidenced by an ICD-1o code/s.

We will use a multivariable logistic regression analysis. Potential confounders assessed for inclusion in the model will be age, gender, First Nations status, COVID-19 vaccine dose (3 or more versus <3) and influenza vaccination status at the time of testing PCR positive, time since last COVID-19 vaccine dose (6 or more months versus <6) at the time of testing PCR positive, and socioeconomic advantage and disadvantage using the Index of Relative Socio-economic Advantage and Disadvantage (IRSAD) produced form the Australian Bureau of Statistics Socio-Economic Indexes for Areas (SEIFA), Australia. Each of these (binary) variables will be assessed against the primary outcome of interest (health complication/s evidenced by ICD-10 code within 12 months of test) at a univariable level using chi-square tests. Those that are significant at the 10% level in the univariable analysis will included in the multivariable logistic regression model. Adjusted odds ratios (aORs) and 95%CI were reported. Variables that were no longer significant in the multivariable logistic regression model will be dropped.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
3500000
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314265 0
Government body
Name [1] 314265 0
Queensland Health
Country [1] 314265 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
33 Charlotte Street
Brisbane Qld 4001
Country
Australia
Secondary sponsor category [1] 316204 0
None
Name [1] 316204 0
Address [1] 316204 0
Country [1] 316204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313384 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 313384 0
199 Ipswich Road, Woolloongabba, QLD 4102
Ethics committee country [1] 313384 0
Australia
Date submitted for ethics approval [1] 313384 0
30/05/2023
Approval date [1] 313384 0
07/06/2023
Ethics approval number [1] 313384 0
HREC/2023/QMS/94243

Summary
Brief summary
This research project aims to:
a) To examine the risks of subsequent health complications (determined by ICD-10AM code) in the 12 months following COVID-19 or influenza infection, compared with a control group (no recent evidence of COVID-19 or influenza infection).
b) inform Queensland Health about the potential scale of post-viral impacts arising from COVID-19 or influenza, and any system-wide response that may be required.

The Project Team is part of the Office of the Chief health Officer in Queensland Health, which accesses the Notifiable Conditions System. The system houses information on COVID-19 and influenza positive PCRs, and people with a negative PCR for COVID-19.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127962 0
Mr Matthew Brown
Address 127962 0
Queensland Health
33 Charlotte Street
Brisbane Qld 4001
Country 127962 0
Australia
Phone 127962 0
+61429617077
Fax 127962 0
Email 127962 0
matthew.brown@health.qld.gov.au
Contact person for public queries
Name 127963 0
Mr Matthew Brown
Address 127963 0
Queensland Health
33 Charlotte Street
Brisbane Qld 4001
Country 127963 0
Australia
Phone 127963 0
+61429617077
Fax 127963 0
Email 127963 0
matthew.brown@health.qld.gov.au
Contact person for scientific queries
Name 127964 0
Mr Matthew Brown
Address 127964 0
Queensland Health
33 Charlotte Street
Brisbane Qld 4001
Country 127964 0
Australia
Phone 127964 0
+61429617077
Fax 127964 0
Email 127964 0
matthew.brown@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data on exposures, outcomes and confounding variables.
When will data be available (start and end dates)?
Immediately following publication. Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator:
Matthew Brown
Email: matthew.brown@health.qld.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19672Study protocol    386226-(Uploaded-11-07-2023-15-43-50)-Study-related document.docx
19673Ethical approval    386226-(Uploaded-11-07-2023-15-44-14)-Study-related document.pdf



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.