Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000444987
Ethics application status
Approved
Date submitted
30/03/2020
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
COVID-19 Research Response (ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections COVID-19 Research Response Trial)
Scientific title
ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections COVID-19 Research Response Trial
Secondary ID [1] 300892 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CRR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 (known or suspected) 316825 0
serious acute respiratory infection (SARI), known or suspected 316911 0
Condition category
Condition code
Respiratory 315034 315034 0 0
Other respiratory disorders / diseases
Infection 315086 315086 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Exposure to COVID-19.

Participant involvement is required, including but not limited to extra nasopharyngeal swabs, blood draws, as well as possible surveys (local site intervention is bound to ISARIC protocol).
There may be follow-up after discharge, at 3 and 6 month timepoints (protocol is evolving).
Intervention code [1] 317214 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323333 0
Describe the clinical features of COVID-19. (This is verbatim from submitted protocol)
Timepoint [1] 323333 0
Due to the nature of the evolving pandemic, there is no timeline for the assessment of primary timepoints.
Primary outcome [2] 323383 0
Describe the response to treatment, including supportive care and novel therapeutics, based on data linkage to medical records. (composite primary outcome) (This is verbatim from submitted protocol)
Timepoint [2] 323383 0
Due to the nature of the evolving pandemic, there is no timeline for the assessment of primary timepoints.
Secondary outcome [1] 381713 0
The host responses to infection and therapy over time, including innate and acquired immune rseponses, as measured by circulating levels of immune signalling molecules and gene expression profiling in peripheral blood. (This is verbatim from submitted protocol)
Timepoint [1] 381713 0
Due to the nature of the evolving pandemic, there is no timeline for the assessment of secondary timepoints.

Eligibility
Key inclusion criteria
Suspected or proven novel Coronavirus (nCoV) infection as main reason for admission or presentation to hospital or clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Confirmed diagnosis of a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen

Refusal by participant, parent, or appropriate representative.

Any other reason, as determined by the Lead Investigator or treating clinician, that the patient should not be included in the study, in-line with ICH GCP (E6 R2) requirements and the Australian Code for Responsible Conduct of Research (2018).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/04/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16175 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 29718 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 305343 0
Government body
Name [1] 305343 0
South Metropolitan Health Service
Country [1] 305343 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
11 Robin Warren Dr, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 305711 0
Hospital
Name [1] 305711 0
Fiona Stanley Hospital
Address [1] 305711 0
11 Robin Warren Dr, Murdoch WA 6150
Country [1] 305711 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305676 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 305676 0
Ethics committee country [1] 305676 0
Australia
Date submitted for ethics approval [1] 305676 0
20/03/2020
Approval date [1] 305676 0
06/04/2020
Ethics approval number [1] 305676 0

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

Contacts
Principal investigator
Name 101190 0
Prof Toby Richards
Address 101190 0
The University of Western Australia (M581), 35 Stirling Highway, 6009 Perth, Western Australia, Australia
Country 101190 0
Australia
Phone 101190 0
+61 414654441
Fax 101190 0
Email 101190 0
[email protected]
Contact person for public queries
Name 101191 0
Giuliana Daulerio
Address 101191 0
The University of Western Australia (M581), 35 Stirling Highway, 6009 Perth, Western Australia, Australia
Country 101191 0
Australia
Phone 101191 0
+61 8 6151 1152
Fax 101191 0
Email 101191 0
[email protected]
Contact person for scientific queries
Name 101192 0
Toby Richards
Address 101192 0
The University of Western Australia (M581), 35 Stirling Highway, 6009 Perth, Western Australia, Australia
Country 101192 0
Australia
Phone 101192 0
+61 414654441
Fax 101192 0
Email 101192 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Research team and approved collaborators.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified data as per request from ethics protocol

What types of analyses could be done with individual participant data?
• To be determined.

When can requests for individual participant data be made (start and end dates)?
From:
Start date: 7/4/20 (pending ethical approval)
- Deidentified data will be made available after data is uploaded to the sample collection database.
End date (at least to): 4/4/25

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Please contact study team for obtaining data.
Email: [email protected]


Are there extra considerations when requesting access to individual participant data?
No


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.