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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Cancer; Primary Immune Deficiency Disorder; HIV-1-infection; Immunosuppression Disorders

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital
    • Sydney, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Sydney, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia, 2148
      • Blacktown Hospital
    • Sydney, New South Wales, Australia, 2217
      • St George Hospital
    • Sydney, New South Wales, Australia
      • Westmead Hospital
    • Sydney, New South Wales, Australia
      • Nepean Hospital
    • Sydney, New South Wales, Australia, 2010
      • East Sydney Doctors
    • Sydney, New South Wales, Australia
      • Concord Hospital
    • Sydney, New South Wales, Australia
      • Holdsworth House Medical Practice
    • Sydney, New South Wales, Australia
      • Melanoma Institute Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: Gilead Sciences; Melanoma Institute Australia; St Vincent's Hospital, Sydney; Royal North Shore Hospital; Cancer Council New South Wales; Prince of Wales Hospital, Sydney; St George Hospital, Australia; Liverpool Hospital, Sydney; Holdsworth House Medical Practice; Garvan Institute of Medical Research; Westmead Hospital, Sydney, Australia; Blacktown Hospital, Sydney, Australia; Cancer Institute NSW; Positive Life NSW
• Investigators: Principal Investigator: Mark Polizzotto, MD, Kirby Institute, UNSW

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2020
• Primary Completion (ANTICIPATED): April 27, 2022
• Study Completion (ANTICIPATED): April 27, 2022

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Genetic Diseases, Inborn; COVID-19; Disease; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: 2020-04-CORIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No