Trial Review

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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
11 Robin Warren Dr, Murdoch WA 6150
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
- This clinical trial aims at describing the clinical features of COVID-19, the response to treatment, as well as pathogen replication, excretion and evolution within the host, determinants of severity and transmission using high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood and stool.
- Characterise the host responses to infection and therapy over time, including innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood
- Identify host genetic variants associated with disease progression or severity
- Understand transmissibility and probabilities of different clinical outcomes following exposure and infection
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
Ms 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
Prof 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 individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data as per request from ethics protocol
When will data be available (start and end dates)?
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
Available to whom?
Research team and approved collaborators.
Available for what types of analyses?
To be determined.
How or where can data be obtained?
Please contact study team for obtaining data.
Email: [email protected]


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7467Study protocol    379533-(Uploaded-30-03-2020-15-52-55)-Study-related document.docx
7468Informed consent form    379533-(Uploaded-06-04-2020-10-08-16)-Study-related document.docx


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7467Study protocol    379533-(Uploaded-19-01-2021-19-05-02)-Study-related document.docx
7468Informed consent form    379533-(Uploaded-06-04-2020-10-08-16)-Study-related document.docx
23746Informed consent form    379533-(Uploaded-19-01-2021-19-07-04)-Study-related document.docx

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.