Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000778987p
Ethics application status
Submitted, not yet approved
Date submitted
29/06/2020
Date registered
30/07/2020
Date last updated
30/07/2020
Date data sharing statement initially provided
30/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Persistent lung and arterial inflammation following COVID-19 pneumonia
Scientific title
Persistent lung and arterial inflammation following COVID-19 pneumonia
Secondary ID [1] 301651 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 318065 0
COVID-19 318066 0
Condition category
Condition code
Infection 316101 316101 0 0
Other infectious diseases
Respiratory 316135 316135 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
The study is a multi-centred prospective observational study involving a cohort of 30 adults who are at least 30 days and no more than 45 days post COVID-19 pneumonia diagnosis. Recruited patients will have an 18F-FDG PET/CT scan which will be assessed for persistent areas of increased inflammation in their lung tissue and for inflammation of blood vessels, indicated by measuring the amount of FDG seen in the aorta. The scan will be performed no less than 30 and no more than 45 days from the date of the COVID-19 diagnosis.
Intervention code [1] 317956 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324294 0
18FDG uptake in the lung tissue will be assessed both visually to determine characteristic uptake patterns and quantitatively by measuring the mean standard uptake values of FDG in the lungs.
Timepoint [1] 324294 0
The PET/CT scan will be performed at minimum of 30 days and no more than 45 days post COVID-19 pneumonia diagnosis. The visual and quantitative assessments of the scan will be done within 6 months of the PET/CT scan.
Secondary outcome [1] 384265 0
Aortic inflammation will be quantitatively assessed by measuring the mean standard uptake values of FDG in the aorta.
Timepoint [1] 384265 0
The PET/CT scan will be performed at minimum of 30 days and no more than 45 days post COVID-19 pneumonia diagnosis. The visual and quantitative assessments of the scan will be done within 6 months of the PET/CT scan.

Eligibility
Key inclusion criteria
· Both males and females aged 50 years or greater.
· At minimum of 30 days and no more than 45 days post COVID-19 pneumonia diagnosis.
· Recovered as defined by nasal or oropharyngeal swab confirmed as negative for SARSCoV-
2 in the recovery phase of their illness.
· Evidence of pulmonary infiltrates on chest x-ray or Chest CT (multilobar, interstitial or
ground glass opacities) suggestive of pneumonia during index admission.
· Able to provide informed consent and undergo study procedures
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
· Clinically unstable patients considered unsuitable for 18FDG-PET/CT test
· COVID-19 status unknown at the time of enrolment.
· People with poorly controlled diabetes
· People with known immuno-deficiency or active malignancy.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size will be 30 for this research study. In our previous study of 22 CAP patients
69% of the participants showed persistence or worsening of 18FDG uptake at the 30-day scan. The proposed study of 30 participants would give adequate power as COVID-19 pneumonia is a more severe form of pneumonia compared to CAP caused by other pathogens.
In the unlikely event that there may be some attrition from consent to the PET imaging process, additional participants may be recruited into the study to ensure a total of 30 participants complete the required PET scans.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16992 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 16993 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 16994 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 30656 0
6009 - Nedlands
Recruitment postcode(s) [2] 30657 0
6000 - Perth
Recruitment postcode(s) [3] 30658 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 306084 0
Government body
Name [1] 306084 0
Research Development Unit, WA Dept of Health
Country [1] 306084 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
QEII Medical Centre
Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 306554 0
None
Name [1] 306554 0
Address [1] 306554 0
Country [1] 306554 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306305 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 306305 0
Level 2, A Block
QEII Medical Centre
Hospital Avenue
NEDLANDS WA 6009
Ethics committee country [1] 306305 0
Australia
Date submitted for ethics approval [1] 306305 0
21/05/2020
Approval date [1] 306305 0
Ethics approval number [1] 306305 0

Summary
Brief summary
COVID-19 is associated with a high rate of lung infection (pneumonia), and it is uncertain for how long the inflammatory changes of pneumonia remain in the lungs once people have recovered from their symptoms and whether this is associated with adverse long-term outcomes. This study aims to determine if there are persistent areas of inflammation in the lungs in people who have recovered clinically from COVID-19 pneumonia, and also to assess whether there is evidence of increased blood vessel inflammatory activity in these people. As inflammation has an important role in the development and progression of cardiovascular disease, the persistence of inflammation may be a predictor of increased risk for future heart disease. 18FDG-PET/CT is an imaging test which is very sensitive to detection of inflammation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103438 0
A/Prof Roslyn Francis
Address 103438 0
Dept of Nuclear Medicine & WA PET Service
Sir Charles Gairdner Hospital
G Block, Level 1
QEII Medical Centre
Hospital Avenue
Nedlands WA 6009
Country 103438 0
Australia
Phone 103438 0
+61 864572179
Fax 103438 0
Email 103438 0
[email protected]
Contact person for public queries
Name 103439 0
Ms Elaine Campbell
Address 103439 0
Dept of Nuclear Medicine & WA PET Service
Sir Charles Gairdner Hospital
G Block, Level 1
QEII Medical Centre
Hospital Avenue
Nedlands WA 6009
Country 103439 0
Australia
Phone 103439 0
+61 864572322
Fax 103439 0
Email 103439 0
[email protected]
Contact person for scientific queries
Name 103440 0
A/Prof Roslyn Francis
Address 103440 0
Dept of Nuclear Medicine & WA PET Service
Sir Charles Gairdner Hospital
G Block, Level 1
QEII Medical Centre
Hospital Avenue
Nedlands WA 6009
Country 103440 0
Australia
Phone 103440 0
+61 864572322
Fax 103440 0
Email 103440 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 only a small cohort of patients in this study thus it would be impossible to guarantee their anonymity should their data be made available.


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.