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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04354818
Other study ID # 2020-04-CORIA
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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