COVIDCOSiNNCT04383652
Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales
An observational study of COVID, run by Kirby Institute at 9 sites in Australia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID
- What is being tested?
- Biological sample and clinical data collection
- How many people
- 200 participants
- Where
- 9 sitesAustralia
- Study dates
- 6 May 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Main cohort
- Diagnosed with CoV-SARS-2 infection
- 16 years of age or older
- Have provided informed consent Paediatric cohort
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- Diagnosed with CoV-SARS-2 infection
- Less than 16 years of age
- Informed consent provided by parent or caregiver
Who cannot join
- Main cohort
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- 15 years of age or younger
- Inability or unwillingness to provide informed consent or abide by the requirements of the study Paediatric cohort
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- 16 years of age or older
- Inability or unwillingness of parent or caregiver to provide informed consent or abide by the requirements of the study -
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites, 9 recruiting
- Recruiting
Blacktown Hospital
Blacktown
Marianne Martinello, mmartinello@Kirby.unsw.edu.au
Marianne Martiello
- Recruiting
Royal Prince Alfred Hospital
Camperdown
Angie Pinto, angie.pinto@health.nsw.gov.au
Angie Pinto
- Recruiting
St Vincent's Hospital
Darlinghurst
Gail Matthews, gmatthews@Kirby.unsw.edu.au
Gail Matthews
- Recruiting
Northern Beaches Hospital
Frenchs Forest
Michael Mina, michaelmina2001@yahoo.com
Michael Mina
- Recruiting
NSW Health Pathology
Randwick, New South Wales, 2031
William Rawlinson, 0293861214, w.rawlinson@unsw.edu.au
William Rawlinson
- Recruiting
Prince of Wales Hospital
Randwick, New South Wales, 2031
Jeffrey Post, Jeffrey.Post@health.nsw.gov.au
Jeffrey Post
- Not yet recruiting
Sydney Children's Hospital
Randwick, New South Wales, 2031
Adam Bartlett, abartlett@kirby.unsw.edu.au
Adam Bartlett
- Recruiting
Royal North Shore Hospital
Saint Leonards
Bernard Hudson, Bernard.Hudson@health.nsw.gov.au
Bernard Hudson
- Recruiting
Westmead Hospital
Westmead
Nicky Gilroy, Nicky.Gilroy@health.nsw.gov.au
Nicky Gilroy
About this study
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
- Being tested
- Biological sample and clinical data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample and clinical data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Biological sample and clinical data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronavirus sequencing
The viruses will be sequenced to to help understand epitope specificity
Measured: 4 months post COVID-19 diagnosis.
Secondary outcomes (1)
Coronavirus culturing
The viruses will then be either cultured to study the immune response against them in culture.
Measured: 4 months post COVID-19 diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start6 May 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marianne Martinello, Principal investigator, Kirby Institute, UNSW SydneyRowena Bull, Principal investigator, School of Medical Sciences, UNSW Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383652
- Sponsor's protocol ID
- VISP2005
- Acronym
- COSiN
- Status last verified
- Jun 2021
- First submitted
- 7 May 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to samples and data is governed by the Protocol Steering Committee. Requests can be made to the Committee (via the Principal Investigators).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Coronavirus COVID-19 Outbreak Samples in New South Wales
- ClinicalTrials.gov ID
- NCT04383652
- Acronym / sponsor ID
- COSiN / VISP2005
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 6 May 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult cohort | – | Other: Biological sample and clinical data collection1. 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 | – | Other: Biological sample and clinical data collection1. 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Main cohort
- <!-- -->
Key exclusion criteria (7 listed)
- Main cohort
- <!-- -->
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample and clinical data collectionPlasma 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. | Other | Adult cohort, Paediatric cohort |
Primary outcome
Coronavirus sequencing
Time frame: 4 months post COVID-19 diagnosis.
The viruses will be sequenced to to help understand epitope specificity
1 secondary outcome
Coronavirus culturing
Time frame: 4 months post COVID-19 diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No. Access to samples and data is governed by the Protocol Steering Committee. Requests can be made to the Committee (via the Principal Investigators).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Martinello principal investigator
Kirby Institute, UNSW Sydney
Rowena Bull principal investigator
School of Medical Sciences, UNSW Sydney
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Kirby Institute at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rowena Bull (0293850900, r.bull@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronavirus sequencing (time frame: 4 months post COVID-19 diagnosis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.