Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000041651
Ethics application status
Approved
Date submitted
16/12/2022
Date registered
16/01/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
16/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of ongoing symptoms and functional impacts of people testing PCR-positive to either COVID-19 or influenza, and people testing PCR-negative to these illnesses.
Scientific title
An observational cohort study involving a comparison of ongoing symptoms and functional impacts of people testing PCR-positive to either COVID-19 or influenza, and people testing PCR-negative to these illnesses.
Secondary ID [1] 308238 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 328527 0
Influenza 328528 0
Condition category
Condition code
Public Health 325544 325544 0 0
Health service research
Infection 325578 325578 0 0
Studies of infection and infectious agents
Respiratory 325680 325680 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 were those who received a PCR test result for either COVID-19 or influenza. Participants who tested positive to both were excluded. Not all participants were tested for both illnesses simultaneously, meaning that COVID-19 positive cases were included if they were not also tested for influenza (and vice-versa), however these were small in number.

All participants had a PCR test for COVID-19 or influenza, which occurred in late May and June 2022. The initial follow up covered by the original ethics approval occurred in September 2022. An ethics amendment was approved in May 2023 to allow ongoing research, which relates to further follow up at 12 months after the test result. This occurred in June/July 2023 and involed:
1. re-surveying those from the 3-month cohort who opted to be followed up by Qld Health at a later date; and
2. a new cohort who were not previously contacted in the earlier 3-month iteration of the survey.

Patients who tested positive or negative via PCR to COVID-19 are observed three months and twelve months after their positive result, and asked to complete a short questionnaire to ascertain their ongoing symptoms and degree of functional impairment. There is no observation between the PCR result and the request to complete a short 5 minute questionnaire.

Patients who tested positive via PCR to influenza are also observed three months and 12 months after their positive result, and asked to complete the same questionnaire. There is no observation between the PCR result and the request to complete a short 5 minute questionnaire.
Intervention code [1] 325079 0
Not applicable
Comparator / control treatment
As a retrospective cohort, the primary comparator (“unexposed”) is people who have tested PCR positive to influenza from specimens collected over the same four week period as the COVID-19 PCR positive (“exposed”) group. The research involves contacting groups by text message at three months and at twelve months after their PCR test and a questionnaire based on the Post-COVID Functional Screen tool.

People testing PCR negative to COVID-19 and influenza from specimens collected over the same four week period are included as a secondary comparator group (“unexposed”). Like the primary comparator group, this group is contacted by text message three months and twelve months after their PCR test and offered the same questionnaire. The secondary comparator is included to answer a secondary research question.
Control group
Active

Outcomes
Primary outcome [1] 333386 0
For people with a positive PCR result for COVID-19, use a questionnaire based on the Post-COVID Functional Screening tool (PCFS) at 12 weeks and twelve months after the result.
Timepoint [1] 333386 0
Two timepoints: at 12 weeks and 12 months after PCR test result.
Primary outcome [2] 333387 0
For people with a positive PCR result for influenza, use a questionnaire based on the Post-COVID Functional Screening tool (PCFS) at 12 weeks and 12 months after the result.
Timepoint [2] 333387 0
Two timepoints: at 12 weeks and 12 months after PCR test result.
Primary outcome [3] 333388 0
For people with a negative PCR result for COVID-19 and influenza, use a questionnaire based on the Post-COVID Functional Screening tool (PCFS) at 12 weeks after the result.
Timepoint [3] 333388 0
Two timepoints: at 12 weeks and 12 months after PCR test result.
Secondary outcome [1] 416871 0
Nil.
Timepoint [1] 416871 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
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Those under 18yo at the time of the survey;
- Those who are recorded in the Notifiable Conditions System to have passed away;
- Those who do not have an Australian mobile phone number recorded in these systems.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The number of participants was determined by those who obtained a PCR test for COVID-19 or influenza between 29 May and 25 June 2022. This time period also corresponded to the peak of Queensland's influenza wave. The study recognised that influenza-positive cases would be the smallest cohort, and so the researchers elected to commence the study at the time of the influenza wave.

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

Participants self-rated themselves using the scoring system in the PCFS tool (modified slightly to enable inclusion of the influenza and PCR-negative cohorts).
The primary outcome was defined as moderate to severe functional limitation. Participants were defined as having the primary outcome of interest if they had a PCFS score of 3 or 4. Participants were defined as not having the primary outcome of interest if they had a PCFS score of 0, 1 or 2.

We used a multivariable logistic regression analysis. Potential confounders assessed for inclusion in the model were age, gender, First Nations status, COVID-19 vaccine dose (3 or more versus <3) 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 were assessed against the primary outcome of interest (moderate to severe functional limitation) at a univariable level using chi-square tests. Those that were significant at the 10% level in the univariable analysis were 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 were dropped.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/09/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
30/06/2023
Date of last data collection
Anticipated
30/06/2023
Actual
30/06/2023
Sample size
Target
30000
Accrual to date
Final
30040
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312495 0
Government body
Name [1] 312495 0
Queensland Health
Country [1] 312495 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
33 Charlotte Street
Brisbane Qld 4001
Country
Australia
Secondary sponsor category [1] 314084 0
None
Name [1] 314084 0
Address [1] 314084 0
Country [1] 314084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311830 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 311830 0
Ethics committee country [1] 311830 0
Australia
Date submitted for ethics approval [1] 311830 0
06/09/2022
Approval date [1] 311830 0
08/09/2022
Ethics approval number [1] 311830 0
HREC/2022/QMS/88587

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

Contacts
Principal investigator
Name 122522 0
Mr Matthew Brown
Address 122522 0
Queensland Health
33 Charlotte Street
Brisbane QLD 4001
Country 122522 0
Australia
Phone 122522 0
+61429617077
Fax 122522 0
Email 122522 0
[email protected]
Contact person for public queries
Name 122523 0
Matthew Brown
Address 122523 0
Queensland Health
33 Charlotte Street
Brisbane QLD 4001
Country 122523 0
Australia
Phone 122523 0
+61429617077
Fax 122523 0
Email 122523 0
[email protected]
Contact person for scientific queries
Name 122524 0
Matthew Brown
Address 122524 0
Queensland Health
33 Charlotte Street
Brisbane QLD 4001
Country 122524 0
Australia
Phone 122524 0
+61429617077
Fax 122524 0
Email 122524 0
[email protected]

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: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17872Study protocol    384866-(Uploaded-02-06-2023-08-49-09)-Study-related document.docx
17873Ethical approval    384866-(Uploaded-02-06-2023-08-50-03)-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.