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Trial registered on ANZCTR
Registration number
ACTRN12620000609954
Ethics application status
Approved
Date submitted
14/05/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Covid-19 Biobank of clinical samples and data for use in research to help understand the immune characteristics of people who are diagnosed with COVID19.
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Scientific title
Covid-19 Biobank: a clinical database and biological bank of clinical samples from individuals with COVID-19 infection to better characterise the clinical course and pathogenesis of the infection and provide insights into potential therapeutic agents
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Secondary ID [1]
301303
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Nil Known
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Universal Trial Number (UTN)
U1111-1252-1632
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
317465
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Condition category
Condition code
Infection
315564
315564
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0
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Other infectious diseases
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Respiratory
315592
315592
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Establish a clinical database and biological bank of clinical samples from individuals with
COVID-19 infection to better characterise the clinical course and pathogenesis of the
infection and provide insights into potential therapeutic agents.
There are two groups
1-intensive sampling group- requires consent to have samples (viral nasal/throat swab and blood for plasma and PBMCs) collected up to 6 time points-from date of COVID-19 diagnosis (0, day 3, day 7, day14-28, 3-6month, & 9-12months. Samples are collected in both the inpatients and community setting. Clinical data and health outcomes data is collected at each time point from data linkage to patient medical records or directly from the participant.
2-observational group - waiver of consent, bio banking of remnant/discarded samples taken from the participant from time of COVID19 diagnosis at their health care institution and matched minimal clinical data linkage to patient medical records
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Intervention code [1]
317590
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
323804
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Create biological bank of clinical samples (viral nose/throat swabs, blood samples and remnant samples) from individuals with COVID-19 infection who are in high risk groups for poor outcomes or critically unwell
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Assessment method [1]
323804
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Timepoint [1]
323804
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December 2021
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Primary outcome [2]
323805
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Create a database of clinical information including; date of COVID 19 diagnosis, risk factors of infection, age, gender, co-morbidities, NEWS score, health status assessment, of infected individuals from hospital medical records
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Assessment method [2]
323805
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Timepoint [2]
323805
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December 2021
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Secondary outcome [1]
382953
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Create a process to enable access to researchers to samples and clinical data to aid in the better characterisation of the clinical course and pathogenesis of COVID-19 infection and provide insights into potential therapeutic agents.
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Assessment method [1]
382953
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Timepoint [1]
382953
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April 2025
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Eligibility
Key inclusion criteria
Age greater than or equal to 18 years of age
Confirmed COVID-19 infection by nucleic acid testing
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
none
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
N/A
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
16/04/2020
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Date of last participant enrolment
Anticipated
30/04/2021
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Actual
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Date of last data collection
Anticipated
30/04/2025
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Actual
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Sample size
Target
250
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
16665
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The Alfred - Melbourne
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Recruitment hospital [2]
16666
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Epworth Richmond - Richmond
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Recruitment hospital [3]
16667
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Cabrini Hospital - Malvern - Malvern
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Recruitment hospital [4]
16668
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Box Hill Hospital - Box Hill
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Recruitment hospital [5]
16669
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Frankston Hospital - Frankston
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Recruitment hospital [6]
16670
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
30261
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3004 - Melbourne
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Recruitment postcode(s) [2]
30262
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3121 - Richmond
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Recruitment postcode(s) [3]
30263
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3144 - Malvern
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Recruitment postcode(s) [4]
30264
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3128 - Box Hill
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Recruitment postcode(s) [5]
30265
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3199 - Frankston
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Recruitment postcode(s) [6]
30266
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
305730
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Charities/Societies/Foundations
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Name [1]
305730
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Lord Mayors Charitable Fund
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Address [1]
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Postal Address
GPO Box 1851
Melbourne, Victoria
Australia 3001
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Country [1]
305730
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Australia
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Primary sponsor type
Hospital
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Name
Alfred Health
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Address
55 Commercial Rd
Melbourne VIC 3004
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Country
Australia
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Secondary sponsor category [1]
306154
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None
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Name [1]
306154
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Address [1]
306154
0
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Country [1]
306154
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306005
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
306005
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55 Commercial Rd
Melbourne Vic 3004
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Ethics committee country [1]
306005
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Australia
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Date submitted for ethics approval [1]
306005
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30/03/2020
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Approval date [1]
306005
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09/04/2020
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Ethics approval number [1]
306005
0
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Summary
Brief summary
Establish a clinical database and biological bank of clinical samples from individuals with COVID-19 infection to better characterise the clinical course and pathogenesis of the infection and provide insights into potential therapeutic agents. Individuals that provide consent to give additional samples of blood and nose/throat swabs will be referred to as the intensive sampling group. This group will be recruited when they are hospital inpatients or from the community if they have been diagnosed with COVID-19 and not been admitted to hospital. These individuals will also consent to clinical data being collected from their medical record and any residual samples obtained for routine clinical care being stored in the Bio-bank..
Individuals who are unable to provide informed consent will be referred to as the
observational group; these may consist of individuals who have been identified
following hospital discharge that are not able to be contacted to be consented for
intensive sampling . These individuals will have clinical data collected from the medical
record retrospectively and any residual samples obtained from clinical care also being stored in the bio-bank. Individuals for whom no residual specimens are available will not be
included in this study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
102390
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Dr James McMahon
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Address
102390
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Department of Infectious Diseases, The Alfred and Central Clinical School, Monash University, Melbourne, Australia
Level 2, Burnet Institute, 85 Commercial Rd, VIC 3004
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Country
102390
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Australia
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Phone
102390
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+61 3 9076 8004
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Fax
102390
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+61 3 9076 2431
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Email
102390
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[email protected]
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Contact person for public queries
Name
102391
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Ms Janine Roney
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Address
102391
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Department of Infectious Diseases, The Alfred and Central Clinical School, Monash University, Melbourne, Australia
Level 2, Burnet Institute, 85 Commercial Rd, VIC 3004
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Country
102391
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Australia
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Phone
102391
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+61 3 9076 2296
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Fax
102391
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+613 9076 2431
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Email
102391
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[email protected]
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Contact person for scientific queries
Name
102392
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Ms Janine Roney
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Address
102392
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Department of Infectious Diseases, The Alfred and Central Clinical School, Monash University, Melbourne, Australia
Level 2, Burnet Institute, 85 Commercial Rd, VIC 3004
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Country
102392
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Australia
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Phone
102392
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+61 3 9076 2296
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Fax
102392
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+613 9076 2431
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Email
102392
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Currently due to the small number recruited into the biobank the IPD at this time might not be able to provided complete anonymity for the participants.
This is expected to change once the number of participants the bio bank increases
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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.
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