Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales

Study Overview
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Brief Summary
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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.

Official Title
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Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales

Conditions
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COVID

Intervention / Treatment
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* Other: Biological sample and clinical data collection


Participation Criteria
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Eligibility Criteria
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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 -
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult cohort<br>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<br>* 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.<br>|
| Paediatric cohort<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronavirus sequencing | The viruses will be sequenced to to help understand epitope specificity | 4 months post COVID-19 diagnosis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronavirus culturing | The viruses will then be either cultured to study the immune response against them in culture. | 4 months post COVID-19 diagnosis. |