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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-11

Study Completion Date

2022-04-27

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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People living with HIV

No interventions assigned to this group

Recipients of Solid Organ Transplants

No interventions assigned to this group

People Living with Cancer

No interventions assigned to this group

People with acquired immunodeficiency

Patients with acquired immunodeficiency associated with other immunosuppressive therapy.

No interventions assigned to this group

People with primary immunodeficiency

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Polizzotto, MD

Role: PRINCIPAL_INVESTIGATOR

Kirby Institute

Locations

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