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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Nil

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People living with HIV<br> | |
| Recipients of Solid Organ Transplants<br> | |
| People Living with Cancer<br> | |
| People with acquired immunodeficiency<br>Patients with acquired immunodeficiency associated with other immunosuppressive therapy. | |
| People with primary immunodeficiency<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died |  | 3 months |