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

NCT04383652 | Unknown

• 1 other identifier: VISP2005
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 9

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

• Coronavirus sequencing

  The viruses will be sequenced to to help understand epitope specificity

  4 months post COVID-19 diagnosis.

Secondary Outcomes (1)

• Coronavirus culturing

  4 months post COVID-19 diagnosis.

Study Arms (2)

Adult cohort

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.

Other: Biological sample and clinical data collection

Paediatric cohort

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.

Other: Biological sample and clinical data collection

Interventions

Biological sample and clinical data collection OTHER

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.

Adult cohort; Paediatric cohort

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Main cohort
• Diagnosed with CoV-SARS-2 infection
• 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

You may not qualify if:

• Main cohort
• <!-- -->
• years of age or younger
• Inability or unwillingness to provide informed consent or abide by the requirements of the study Paediatric cohort
• <!-- -->
• years of age or older
• Inability or unwillingness of parent or caregiver to provide informed consent or abide by the requirements of the study -

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (9)

NSW Health Pathology

Randwick, New South Wales, 2031, Australia

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

NOT YET RECRUITING

Blacktown Hospital

Blacktown, Australia

RECRUITING

Royal Prince Alfred Hospital

Camperdown, Australia

RECRUITING

St Vincent's Hospital

Darlinghurst, Australia

RECRUITING

Northern Beaches Hospital

Frenchs Forest, Australia

RECRUITING

Royal North Shore Hospital

Saint Leonards, Australia

RECRUITING

Westmead Hospital

Westmead, Australia

RECRUITING

Study Officials

• Marianne Martinello

  Kirby Institute, UNSW Sydney

  PRINCIPAL INVESTIGATOR

• Rowena Bull

  School of Medical Sciences, UNSW Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rowena Bull

CONTACT

0293850900; r.bull@unsw.edu.au

Marianne Martinello

CONTACT

0293850900; mmartinello@Kirby.unsw.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: May 6, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9)