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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04354818




Registration number
NCT04354818
Ethics application status
Date submitted
16/04/2020
Date registered
21/04/2020
Date last updated
1/09/2021

Titles & IDs
Public title
Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (CORIA)
Scientific title
Coronavirus Outcomes Registries in Immunocompromised Individuals Australia (CORIA): a Multisite Registry and Optional Biorepository in People With COVID-19 and Selected Conditions Affecting Immune Function
Secondary ID [1] 0 0
2020-04-CORIA
Universal Trial Number (UTN)
Trial acronym
CORIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1-infection 0 0
Cancer 0 0
Primary Immune Deficiency Disorder 0 0
Immunosuppression Disorders 0 0
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People living with HIV -

Recipients of Solid Organ Transplants -

People Living with Cancer -

People with acquired immunodeficiency - Patients with acquired immunodeficiency associated with other immunosuppressive therapy.

People with primary immunodeficiency -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
Timepoint [1] 0 0
Day 28
Secondary outcome [1] 0 0
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
1. Presenting (in person or via telemedicine) for evaluation because they:

* Have clinical symptoms consistent with for COVID-19:
* Fever (= 37.8 °C) on examination OR patient reported fever (= 37.8 °C) or feverishness (felt febrile but did not take temperature) OR any of, cough, sore throat, shortness of breath, rhinorrhoea, headache, chills, generalise myalgia, malaise, fatigue, confusion, diarrhea, nausea or vomiting
* Have been contacted because they have been identified as a contact to a confirmed case
* Have been contacted and told they tested positive for COVID-19
2. Have one of the following conditions affecting immune function:

* Known or suspected primary immunodeficiency, defined as a predisposition to infection associated with an apparent or presumed deficit of immune function
* On immunosuppressive therapy
* Treatment with immune checkpoint inhibitors within 36 months of enrolment date
* HIV infection
* Diagnosis of cancer within 36 months of enrolment date, excluding superficial basal cell and squamous cell carcinomas
* Solid organ transplantation
3. For optional biobanking only, ability to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Nil

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/04/2022
Actual
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
East Sydney Doctors - Sydney
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [5] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [6] 0 0
St George Hospital - Sydney
Recruitment hospital [7] 0 0
Concord Hospital - Sydney
Recruitment hospital [8] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [9] 0 0
Melanoma Institute Australia - Sydney
Recruitment hospital [10] 0 0
Nepean Hospital - Sydney
Recruitment hospital [11] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2148 - Sydney
Recruitment postcode(s) [5] 0 0
2170 - Sydney
Recruitment postcode(s) [6] 0 0
2217 - Sydney
Recruitment postcode(s) [7] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital, Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Garvan Institute of Medical Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Westmead Hospital, Sydney, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Blacktown Hospital, Sydney, Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Holdsworth House Medical Practice
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Royal North Shore Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Melanoma Institute Australia
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Government body
Name [8] 0 0
Prince of Wales Hospital, Sydney
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Commercial sector/industry
Name [9] 0 0
Gilead Sciences
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Cancer Institute NSW
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Cancer Council New South Wales
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Positive Life NSW
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
St George Hospital, Australia
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Liverpool Hospital, Sydney
Address [14] 0 0
Country [14] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.
Trial website
https://clinicaltrials.gov/study/NCT04354818
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Polizzotto, MD
Address 0 0
Kirby Institute, UNSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04354818