Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000486921
Ethics application status
Approved
Date submitted
11/04/2020
Date registered
17/04/2020
Date last updated
22/03/2021
Date data sharing statement initially provided
17/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
AUSTRALIAN CARDIOVASCULAR COVID-19 REGISTRY (AUS-COVID)
Scientific title
AUSTRALIAN CARDIOVASCULAR COVID-19 REGISTRY (AUS-COVID)
Secondary ID [1] 300887 0
None
Universal Trial Number (UTN)
Trial acronym
AUS-COVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317029 0
SARS-CoV-2 Infection 317030 0
Condition category
Condition code
Infection 315194 315194 0 0
Other infectious diseases
Respiratory 315261 315261 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
0
Target follow-up type
Days
Description of intervention(s) / exposure
Patients who are hospitalised with acute SARS-CoV-2 infection. Patients will only be observed until discharge from hospital or termination of the study (whichever comes first). Data will be collected from hospital medical records. There will not be any follow up outside of hospital.
Intervention code [1] 317313 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323449 0
Incidence of in-hospital cardiac complications. This data will be collected from hospital medical records.
Timepoint [1] 323449 0
Discharge from hospital
Secondary outcome [1] 381982 0
Rate of intubation. This data will be collected from hospital medical records.
Timepoint [1] 381982 0
Discharge from hospital
Secondary outcome [2] 381986 0
in-hospital mortality. This data will be collected from hospital medical records.
Timepoint [2] 381986 0
Discharge from hospital

Eligibility
Key inclusion criteria
Patients admitted to hospital with laboratory confirmed acute SARS-CoV-2 infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years

Suspected acute SARS-CoV-2 infection but not laboratory confirmed

Transferred from another hospital

Presented to the emergency department but not admitted to hospital

Presented to an outpatient fever clinic (or equivelant) but not admitted to hospital

Admitted to a “virtual hospital” only (i.e. never admitted to a physical hospital ward)

Previous admission to hospital for acute SARS-CoV-2 infection (patient must have been previously admitted to hospital not just an emergency department presentation, a fever clinic (or equivalent) presentation or a“virtual hospital” admission)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
The number of participants required for the primary endpoint is 865.
Confidence level = 0.95
Precision = 0.02
Estimated true proportion = 0.10
n = (1.96^2×0.1×0.9)/0.02^2 =865
Appropriate statistical methods will be used to establish the incidence of cardiac complications and to compare outcomes in patients with and without pre-existing cardiovascular disease. Broadly categorical data will be analysed using student t-test, and continuous variables will be analysed with regression analysis. Where appropriate, survival analysis, including Kaplan-Meier estimates will be used. An interim analysis will be performed when 217 patients (25% of planned sample size) have been enrolled. A subgroup analysis will be performed in patients with suspected hospital-acquired COVID-19.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2020
Actual
22/05/2020
Date of last participant enrolment
Anticipated
1/08/2021
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
865
Accrual to date
724
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 16428 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 16429 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 16430 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [4] 16431 0
Lismore Base Hospital - Lismore
Recruitment hospital [5] 16432 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 16433 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 16434 0
North Shore Private Hospital - St Leonards
Recruitment hospital [8] 16435 0
Prince of Wales Hospital - Randwick
Recruitment hospital [9] 16436 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 16437 0
Westmead Hospital - Westmead
Recruitment hospital [11] 16438 0
Wollongong Hospital - Wollongong
Recruitment hospital [12] 16439 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [13] 16440 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [14] 16441 0
The Prince Charles Hospital - Chermside
Recruitment hospital [15] 16442 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [16] 16443 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [17] 16444 0
Royal Perth Hospital - Perth
Recruitment hospital [18] 16477 0
The Northern Hospital - Epping
Recruitment hospital [19] 16478 0
The Alfred - Melbourne
Recruitment hospital [20] 16479 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [21] 18979 0
Belmont Hospital - Belmont
Recruitment hospital [22] 18980 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [23] 18981 0
Ryde Hospital - Eastwood
Recruitment hospital [24] 18982 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 29971 0
2139 - Concord
Recruitment postcode(s) [2] 29972 0
2305 - New Lambton
Recruitment postcode(s) [3] 29973 0
2290 - Gateshead
Recruitment postcode(s) [4] 29974 0
2480 - Lismore
Recruitment postcode(s) [5] 29975 0
2170 - Liverpool
Recruitment postcode(s) [6] 29976 0
2747 - Kingswood
Recruitment postcode(s) [7] 29977 0
2065 - St Leonards
Recruitment postcode(s) [8] 29978 0
2031 - Randwick
Recruitment postcode(s) [9] 29979 0
2145 - Westmead
Recruitment postcode(s) [10] 29980 0
2500 - Wollongong
Recruitment postcode(s) [11] 29981 0
3065 - Fitzroy
Recruitment postcode(s) [12] 29982 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 29983 0
4032 - Chermside
Recruitment postcode(s) [14] 29984 0
5042 - Bedford Park
Recruitment postcode(s) [15] 29985 0
5000 - Adelaide
Recruitment postcode(s) [16] 29986 0
6000 - Perth
Recruitment postcode(s) [17] 30028 0
3076 - Epping
Recruitment postcode(s) [18] 30029 0
3004 - Melbourne
Recruitment postcode(s) [19] 30030 0
6150 - Murdoch
Recruitment postcode(s) [20] 33486 0
2280 - Belmont
Recruitment postcode(s) [21] 33487 0
2050 - Camperdown
Recruitment postcode(s) [22] 33488 0
2122 - Eastwood
Recruitment postcode(s) [23] 33489 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305339 0
Charities/Societies/Foundations
Name [1] 305339 0
Ramsay Hospital Research Foundation
Country [1] 305339 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Road
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 305831 0
None
Name [1] 305831 0
Address [1] 305831 0
Country [1] 305831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305672 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 305672 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 305672 0
Australia
Date submitted for ethics approval [1] 305672 0
26/03/2020
Approval date [1] 305672 0
15/04/2020
Ethics approval number [1] 305672 0
2020/ETH00732

Summary
Brief summary
Patients with pre-existing cardiovascular disease (CVD) have been shown to have a higher mortality from COVID-19 than the general population. Early data from small case series suggests that cardiac complications such as acute cardiac injury, myocarditis and cardiomyopathy are common in patients with COVID-19. Given COVID-19 has become a pandemic, urgent data is required to better understand the cardiovascular sequelae of the infection as well as the effects of pre-existing CVD. The AUS-COVID registry will provide this time critical data needed by clinicians and health services to be better prepared to manage these patients.
Trial website
https://www.aus-covid.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101174 0
Prof Ravinay Bhindi
Address 101174 0
Cardiology Department
Royal North Shore Hospital
Reserve Road, St Leonards, NSW, 2065
Country 101174 0
Australia
Phone 101174 0
+61 2 9926 7111
Fax 101174 0
Email 101174 0
[email protected]
Contact person for public queries
Name 101175 0
Prof Ravinay Bhindi
Address 101175 0
Cardiology Department
Royal North Shore Hospital
Reserve Road, St Leonards, NSW, 2065
Country 101175 0
Australia
Phone 101175 0
+61 2 9926 7111
Fax 101175 0
Email 101175 0
[email protected]
Contact person for scientific queries
Name 101176 0
Prof Ravinay Bhindi
Address 101176 0
Cardiology Department
Royal North Shore Hospital
Reserve Road, St Leonards, NSW, 2065
Country 101176 0
Australia
Phone 101176 0
+61 2 9926 7111
Fax 101176 0
Email 101176 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
Ethics application does not cover IPD sharing.


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
SourceTitleYear of PublicationDOI
EmbaseCardiac Complications in Patients Hospitalised With COVID-19 in Australia.2021https://dx.doi.org/10.1016/j.hlc.2021.08.001
EmbaseAssociation of hypertension with mortality in patients hospitalised with COVID-19.2021https://dx.doi.org/10.1136/openhrt-2021-001853
N.B. These documents automatically identified may not have been verified by the study sponsor.