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

June 28, 2021 updated by: Kirby Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Blacktown, Australia
      • Camperdown, Australia
      • Darlinghurst, Australia
        • Recruiting
        • St Vincent's Hospital
      • Frenchs Forest, Australia
        • Recruiting
        • Northern Beaches Hospital
        • Contact:
        • Principal Investigator:
          • Michael Mina
      • Saint Leonards, Australia
      • Westmead, Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Prince Of Wales Hospital
      • Randwick, New South Wales, Australia, 2031
        • Not yet recruiting
        • Sydney Children's Hospital
        • Contact:
        • Principal Investigator:
          • Adam Bartlett
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • NSW Health Pathology
        • Contact:
        • Principal Investigator:
          • William Rawlinson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronavirus sequencing
Time Frame: 4 months post COVID-19 diagnosis.
The viruses will be sequenced to to help understand epitope specificity
4 months post COVID-19 diagnosis.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronavirus culturing
Time Frame: 4 months post COVID-19 diagnosis.
The viruses will then be either cultured to study the immune response against them in culture.
4 months post COVID-19 diagnosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Investigators

  • Principal Investigator: Marianne Martinello, Kirby Institute, UNSW Sydney
  • Principal Investigator: Rowena Bull, School of Medical Sciences, UNSW Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISP2005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Access to samples and data is governed by the Protocol Steering Committee. Requests can be made to the Committee (via the Principal Investigators).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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