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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04354818

Acronym

CORIA

Enrollment

Registered

2020-04-21

Start date

2020-05-11

Completion date

2022-04-27

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, COVID-19, HIV-1-infection, Immunosuppression Disorders, Primary Immune Deficiency Disorder

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results