Trial Review

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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.
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
Secondary ID [1] 301303 0
Nil Known
Universal Trial Number (UTN)
U1111-1252-1632
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317465 0
Condition category
Condition code
Infection 315564 315564 0 0
Other infectious diseases
Respiratory 315592 315592 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
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
Intervention code [1] 317590 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323804 0
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
Timepoint [1] 323804 0
December 2021
Primary outcome [2] 323805 0
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
Timepoint [2] 323805 0
December 2021
Secondary outcome [1] 382953 0
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.
Timepoint [1] 382953 0
April 2025

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years of age
Confirmed COVID-19 infection by nucleic acid testing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
N/A

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/04/2020
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
250
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16665 0
The Alfred - Melbourne
Recruitment hospital [2] 16666 0
Epworth Richmond - Richmond
Recruitment hospital [3] 16667 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 16668 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 16669 0
Frankston Hospital - Frankston
Recruitment hospital [6] 16670 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 30261 0
3004 - Melbourne
Recruitment postcode(s) [2] 30262 0
3121 - Richmond
Recruitment postcode(s) [3] 30264 0
3128 - Box Hill
Recruitment postcode(s) [4] 30263 0
3144 - Malvern
Recruitment postcode(s) [5] 30266 0
3168 - Clayton
Recruitment postcode(s) [6] 30265 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 305730 0
Charities/Societies/Foundations
Name [1] 305730 0
Lord Mayors Charitable Fund
Country [1] 305730 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 306154 0
None
Name [1] 306154 0
Address [1] 306154 0
Country [1] 306154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306005 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 306005 0
55 Commercial Rd
Melbourne Vic 3004
Ethics committee country [1] 306005 0
Australia
Date submitted for ethics approval [1] 306005 0
30/03/2020
Approval date [1] 306005 0
09/04/2020
Ethics approval number [1] 306005 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102390 0
Dr James McMahon
Address 102390 0
Department of Infectious Diseases, The Alfred and Central Clinical School, Monash University, Melbourne, Australia
Level 2, Burnet Institute, 85 Commercial Rd, VIC 3004
Country 102390 0
Australia
Phone 102390 0
+61 3 9076 8004
Fax 102390 0
+61 3 9076 2431
Email 102390 0
james.mcmahon@monash.edu
Contact person for public queries
Name 102391 0
Ms Janine Roney
Address 102391 0
Department of Infectious Diseases, The Alfred and Central Clinical School, Monash University, Melbourne, Australia
Level 2, Burnet Institute, 85 Commercial Rd, VIC 3004
Country 102391 0
Australia
Phone 102391 0
+61 3 9076 2296
Fax 102391 0
+613 9076 2431
Email 102391 0
j.roney@alfred.org.au
Contact person for scientific queries
Name 102392 0
Ms Janine Roney
Address 102392 0
Department of Infectious Diseases, The Alfred and Central Clinical School, Monash University, Melbourne, Australia
Level 2, Burnet Institute, 85 Commercial Rd, VIC 3004
Country 102392 0
Australia
Phone 102392 0
+61 3 9076 2296
Fax 102392 0
+613 9076 2431
Email 102392 0
j.roney@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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


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.