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

Kirby Institute

Status: Unknown

Conditions: COVID

Treatments: Other: Biological sample and clinical data collection

Study type: Observational

Funder types: Other

Identifiers

NCT04383652

VISP2005

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
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  1. Diagnosed with CoV-SARS-2 infection

  2. Less than 16 years of age

  3. Informed consent provided by parent or caregiver

     Exclusion Criteria:

     Main cohort

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  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
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  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 -

Trial design

200 participants in 2 patient groups

Adult cohort

Description:

1. Diagnosed with SARS-CoV-2 infection (COVID-19; by a registered diagnostic facility) 2. Age 16 years or older 3. Have provided informed consent Blood samples and clinical data related to COVID19 diagnosis, symptoms, and outcomes will be collected.

Treatment:

Other: Biological sample and clinical data collection

Paediatric cohort

Description:

1. Diagnosed with SARS-CoV-2 infection (COVID-19; by a registered diagnostic facility) 2. Age less than 16 years 3. Parent or caregiver has provided informed consent Blood samples and clinical data related to COVID19 diagnosis, symptoms, and outcomes will be collected.

Treatment:

Other: Biological sample and clinical data collection