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

NCT ID: NCT04383652

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-06

Study Completion Date

2022-06-30

Brief Summary

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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

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Conditions

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COVID

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biological sample and clinical data collection

Intervention Type 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.

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.

Biological sample and clinical data collection

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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 -
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Martinello

Role: PRINCIPAL_INVESTIGATOR

Kirby Institute, UNSW Sydney

Rowena Bull

Role: PRINCIPAL_INVESTIGATOR

School of Medical Sciences, UNSW Sydney

Locations

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NSW Health Pathology

Randwick, New South Wales, Australia

Site Status RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status RECRUITING

Sydney Children's Hospital

Randwick, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Blacktown Hospital

Blacktown, , Australia

Site Status RECRUITING

Royal Prince Alfred Hospital

Camperdown, , Australia

Site Status RECRUITING

St Vincent's Hospital

Darlinghurst, , Australia

Site Status RECRUITING

Northern Beaches Hospital

Frenchs Forest, , Australia

Site Status RECRUITING

Royal North Shore Hospital

Saint Leonards, , Australia

Site Status RECRUITING

Westmead Hospital

Westmead, , Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Rowena Bull

Role: CONTACT

0293850900

Marianne Martinello

Role: CONTACT

0293850900

Facility Contacts

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William Rawlinson

Role: primary

0293861214

Jeffrey Post

Role: primary

Adam Bartlett

Role: primary

Marianne Martinello

Role: primary

Angie Pinto

Role: primary

Gail Matthews

Role: primary

Michael Mina

Role: primary

Bernard Hudson

Role: primary

Nicky Gilroy

Role: primary

Other Identifiers

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VISP2005

Identifier Type: -

Identifier Source: org_study_id

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