Clinical trial NCT04383652: Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales
Official title: Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2020-05-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be adults, adolescents or children diagnosed with COVID-19 and attending a major teaching hospital located in Sydney, New South Wales Australia.

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.


Eligibility 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 -

Primary outcomes:
measure: Coronavirus sequencing
timeFrame: 4 months post COVID-19 diagnosis.
Secondary outcomes:
measure: Coronavirus culturing
timeFrame: 4 months post COVID-19 diagnosis.
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: NSW Health Pathology
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Blacktown
country: Australia
facility: Blacktown Hospital
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
city: Frenchs Forest
country: Australia
facility: Northern Beaches Hospital
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
Study officials:
affiliation: Kirby Institute, UNSW Sydney
name: Marianne Martinello
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Medical Sciences, UNSW Sydney
name: Rowena Bull
role: PRINCIPAL_INVESTIGATOR
References: