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

• Conditions: COVID
• Interventions: Other: Biological sample and clinical data collection

• Registration Number: NCT04383652
• Lead Sponsor: Kirby Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-29
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult cohort	Biological sample and clinical data collection	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.
Paediatric cohort	Biological sample and clinical data collection	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.

Primary Outcome Measures

Name	Time	Method
Coronavirus sequencing	4 months post COVID-19 diagnosis.	The viruses will be sequenced to to help understand epitope specificity

Secondary Outcome Measures

Name	Time	Method
Coronavirus culturing	4 months post COVID-19 diagnosis.	The viruses will then be either cultured to study the immune response against them in culture.

Trial Locations

Locations (9)

NSW Health Pathology; 🇦🇺 Randwick, New South Wales, Australia

Sydney Children's Hospital; 🇦🇺 Randwick, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Blacktown Hospital; 🇦🇺 Blacktown, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, Australia

St Vincent's Hospital; 🇦🇺 Darlinghurst, Australia

Northern Beaches Hospital; 🇦🇺 Frenchs Forest, Australia

Westmead Hospital; 🇦🇺 Westmead, Australia

Royal North Shore Hospital; 🇦🇺 Saint Leonards, Australia