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

Cancer Clinical Trial

— CORIA  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04354818
• Other study ID #: 2020-04-CORIA
• Status: Active, not recruiting
• Start date: May 11, 2020
• Est. completion date: April 27, 2022

Study information

• Verified date: August 2021
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• COVID-19
• Disease
• HIV-1-infection
• Immunologic Deficiency Syndromes
• Immunosuppression Disorders
• Primary Immune Deficiency Disorder

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Blacktown Hospital	Sydney	New South Wales
Australia	Concord Hospital	Sydney	New South Wales
Australia	East Sydney Doctors	Sydney	New South Wales
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Melanoma Institute Australia	Sydney	New South Wales
Australia	Nepean Hospital	Sydney	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales

Sponsors (15)

Lead Sponsor

Collaborator

Kirby Institute

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

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died		Day 28
Secondary	percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died		3 months