Clinical trial NCT04354818: Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Cancer
Primary Immune Deficiency Disorder
Immunosuppression Disorders
COVID-19
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: St Vincent's Hospital, Sydney
name: Garvan Institute of Medical Research
name: Westmead Hospital, Sydney, Australia
name: Blacktown Hospital, Sydney, Australia
name: Holdsworth House Medical Practice
name: Royal North Shore Hospital
name: Melanoma Institute Australia
name: Prince of Wales Hospital, Sydney
name: Gilead Sciences
name: Cancer Institute NSW
name: Cancer Council New South Wales
name: Positive Life NSW
name: St George Hospital, Australia
name: Liverpool Hospital, Sydney
First posted: 2020-04-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
timeFrame: Day 28
Secondary outcomes:
measure: percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
timeFrame: 3 months
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Concord Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Sydney
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: Kirby Institute
name: Mark Polizzotto, MD
role: PRINCIPAL_INVESTIGATOR
References: