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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04383652




Registration number
NCT04383652
Ethics application status
Date submitted
7/05/2020
Date registered
12/05/2020
Date last updated
12/05/2020

Titles & IDs
Public title
Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales
Scientific title
Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales
Secondary ID [1] 0 0
VISP2005
Universal Trial Number (UTN)
Trial acronym
COSiN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Biological sample and clinical data collection

Adult cohort - Diagnosed with SARS-CoV-2 infection (COVID-19; by a registered diagnostic facility)
Age 16 years or older
Have provided informed consent
Blood samples and clinical data related to COVID19 diagnosis, symptoms, and outcomes will be collected.

Paediatric cohort - Diagnosed with SARS-CoV-2 infection (COVID-19; by a registered diagnostic facility)
Age less than 16 years
Parent or caregiver has provided informed consent Blood samples and clinical data related to COVID19 diagnosis, symptoms, and outcomes will be collected.


Other interventions: Biological sample and clinical data collection
Plasma and serum will be collected at day 0, day 7, day 14, 1 month and 4 months post diagnosis. Clinical data related to COVID-19 diagnosis, symptoms, and outcomes will be collected.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Coronavirus sequencing - The viruses will be sequenced to to help understand epitope specificity
Timepoint [1] 0 0
4 months post COVID-19 diagnosis.
Secondary outcome [1] 0 0
Coronavirus culturing - The viruses will then be either cultured to study the immune response against them in culture.
Timepoint [1] 0 0
4 months post COVID-19 diagnosis.

Eligibility
Key inclusion criteria
- Main cohort

1. Diagnosed with CoV-SARS-2 infection

2. 16 years of age or older

3. Have provided informed consent Paediatric cohort

1. Diagnosed with CoV-SARS-2 infection

2. Less than 16 years of age

3. Informed consent provided by parent or caregiver
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Main cohort

1. 15 years of age or younger

2. Inability or unwillingness to provide informed consent or abide by the
requirements of the study Paediatric cohort

1. 16 years of age or older

2. Inability or unwillingness of parent or caregiver to provide informed consent or
abide by the requirements of the study -

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
NSW Health Pathology - Randwick
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [7] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [8] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
- Blacktown
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
- Frenchs Forest
Recruitment postcode(s) [6] 0 0
- Saint Leonards
Recruitment postcode(s) [7] 0 0
- Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of this study are to characterise immune responses in people with CoV-SARS-2
infection and use this knowledge to advance vaccine design, treatment options, and diagnostic
reagents. Eligible participants will include people diagnosed with SARS-CoV-2 infection, and
may include recently returned travellers and non-travellers in the community presenting to
tertiary hospital healthcare facilities. Recruitment will be opportunistic, and sampling
intensity may vary depending on the phase of the outbreak. Participants can be enrolled at
any timepoint (up to 6 months) following diagnosis of SARS-CoV-2 infection (COVID-19). Blood
samples and clinical data will be collected.
Trial website
https://clinicaltrials.gov/show/NCT04383652
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marianne Martinello
Address 0 0
Kirby Institute, UNSW Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rowena Bull
Address 0 0
Country 0 0
Phone 0 0
0293850900
Fax 0 0
Email 0 0
r.bull@unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04383652