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

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

• Registration Number: NCT04354818
• Lead Sponsor: Kirby Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-21
• Study Start: 2020-05-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-04-27
• Study Completion: 2022-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died	Day 28

Secondary Outcome Measures

Name	Time	Method
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died	3 months

Trial Locations

Locations (11)

St Vincent's Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

East Sydney Doctors; 🇦🇺 Sydney, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 Sydney, New South Wales, Australia

Blacktown Hospital; 🇦🇺 Sydney, New South Wales, Australia

Liverpool Hospital; 🇦🇺 Sydney, New South Wales, Australia

St George Hospital; 🇦🇺 Sydney, New South Wales, Australia

Concord Hospital; 🇦🇺 Sydney, New South Wales, Australia

Holdsworth House Medical Practice; 🇦🇺 Sydney, New South Wales, Australia

Melanoma Institute Australia; 🇦🇺 Sydney, New South Wales, Australia

Nepean Hospital; 🇦🇺 Sydney, New South Wales, Australia

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