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

COVID Clinical Trial

— COSiN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04383652
• Other study ID #: VISP2005
• Status: Recruiting
• Start date: May 6, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2021
• Source: Kirby Institute
• Contact: Rowena Bull
• Phone: 0293850900
• Email: r.bull[@]unsw.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

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

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

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 -

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID

Intervention

Other:
• Biological sample and clinical data collection
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.

Locations

Country	Name	City	State
Australia	Blacktown Hospital	Blacktown
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	St Vincent's Hospital	Darlinghurst
Australia	Northern Beaches Hospital	Frenchs Forest
Australia	NSW Health Pathology	Randwick	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Sydney Children's Hospital	Randwick	New South Wales
Australia	Royal North Shore Hospital	Saint Leonards
Australia	Westmead Hospital	Westmead

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronavirus sequencing	The viruses will be sequenced to to help understand epitope specificity	4 months post COVID-19 diagnosis.
Secondary	Coronavirus culturing	The viruses will then be either cultured to study the immune response against them in culture.	4 months post COVID-19 diagnosis.