COSiN: Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: 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.
|
| 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: 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.
|
Outcome Measures
Primary Outcome Measures
- Coronavirus sequencing [4 months post COVID-19 diagnosis.]
The viruses will be sequenced to to help understand epitope specificity
Secondary Outcome Measures
- Coronavirus culturing [4 months post COVID-19 diagnosis.]
The viruses will then be either cultured to study the immune response against them in culture.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Main cohort
-
Diagnosed with CoV-SARS-2 infection
-
16 years of age or older
-
Have provided informed consent Paediatric cohort
-
Diagnosed with CoV-SARS-2 infection
-
Less than 16 years of age
-
Informed consent provided by parent or caregiver
Exclusion Criteria:
Main cohort
-
15 years of age or younger
-
Inability or unwillingness to provide informed consent or abide by the requirements of the study Paediatric cohort
-
16 years of age or older
-
Inability or unwillingness of parent or caregiver to provide informed consent or abide by the requirements of the study -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NSW Health Pathology | Randwick | New South Wales | Australia | 2031 |
| 2 | Prince of Wales Hospital | Randwick | New South Wales | Australia | 2031 |
| 3 | Sydney Children's Hospital | Randwick | New South Wales | Australia | 2031 |
| 4 | Blacktown Hospital | Blacktown | Australia | ||
| 5 | Royal Prince Alfred Hospital | Camperdown | Australia | ||
| 6 | St Vincent's Hospital | Darlinghurst | Australia | ||
| 7 | Northern Beaches Hospital | Frenchs Forest | Australia | ||
| 8 | Royal North Shore Hospital | Saint Leonards | Australia | ||
| 9 | Westmead Hospital | Westmead | Australia |
Sponsors and Collaborators
- Kirby Institute
Investigators
- Principal Investigator: Marianne Martinello, Kirby Institute, UNSW Sydney
- Principal Investigator: Rowena Bull, School of Medical Sciences, UNSW Sydney
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VISP2005