Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (CORIA)

NCT04354818 | Unknown

• 1 other identifier: 2020-04-CORIA
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 11

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.

Conditions

HIV-1-infection; Cancer; Primary Immune Deficiency Disorder; Immunosuppression Disorders; COVID-19

Outcome Measures

Primary Outcomes (1)

• percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

  Day 28

Secondary Outcomes (1)

• percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died

  3 months

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged 18 years or older with a known condition affecting immune function (Primary Immune Deficiency, on Immunosuppressive Therapy, on Immune checkpoint inhibitors within 36 months of study enrolment, HIV infection, recipient of Solid Organ Transplant or diagnosis of Cancer within 36 months of study enrolment, excluding superficial basal cell and squamous cell carcinomas) presenting with clinical symptoms consistent with COVID-19 or a known contact to a confirmed case or known to be COVID-19 positive.

You may qualify if:

• 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
• 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
• For optional biobanking only, ability to provide informed consent

You may not qualify if:

• Nil

Sponsors & Collaborators

• Kirby Institute: lead
• St Vincent's Hospital, Sydney: collaborator
• Garvan Institute of Medical Research: collaborator
• Westmead Hospital, Sydney, Australia: collaborator
• Blacktown Hospital, Sydney, Australia: collaborator
• Holdsworth House Medical Practice: collaborator
• Royal North Shore Hospital: collaborator
• Melanoma Institute Australia: collaborator
• Prince of Wales Hospital, Sydney: collaborator
• Gilead Sciences: collaborator
• Cancer Institute NSW: collaborator
• Cancer Council New South Wales: collaborator
• Positive Life NSW: collaborator
• St George Hospital, Australia: collaborator
• Liverpool Hospital, Sydney: collaborator

Study Sites (11)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

East Sydney Doctors

Sydney, New South Wales, 2010, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Blacktown Hospital

Sydney, New South Wales, 2148, Australia

Location

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

Location

St George Hospital

Sydney, New South Wales, 2217, Australia

Location

Concord Hospital

Sydney, New South Wales, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Location

Melanoma Institute Australia

Sydney, New South Wales, Australia

Location

Nepean Hospital

Sydney, New South Wales, Australia

Location

Westmead Hospital

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Neoplasms; Primary Immunodeficiency Diseases; COVID-19

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mark Polizzotto, MD

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: May 11, 2020
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (11)