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
30/08/2024
Date data sharing statement initially provided
27/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of health complications arising 12 months after a PCR-positive test for COVID-19, influenza, and respiratory syncytial virus.
Scientific title
A retrospective analysis of existing epidemiological data that compares health complications arising 12 months after a PCR-positive test for COVID-19, influenza, and respiratory syncytial virus.
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
Respiratory syncytial virus 334988 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 COVID-19, influenza, or respiratory syncytial virus (RSV) from 1 July 2017. Not all participants are tested for these illnesses simultaneously, meaning that COVID-19 positive cases are included if they were not also tested for influenza and RSV (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).

For patients with a record of a positive via PCR test to RSV 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).

A secondary comparator ("unexposed") is people who have tested PCR positive to RSV from 1 July 2021 (when RSV was first recorded in Qld's Notifiable Conditions System). 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 positive PCR result for RSV, 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, influenza, or RSV 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, influenza and RSV 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, influenza, or RSV 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”) or RSV PCR positive (also "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/RSV 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
3500000
Accrual to date
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
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
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
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
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?




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.