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

Kirby Institute

Status: Unknown

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04354818

2020-04-CORIA

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

27 participants in 5 patient groups

People living with HIV

Recipients of Solid Organ Transplants

People Living with Cancer

People with acquired immunodeficiency

Description:

Patients with acquired immunodeficiency associated with other immunosuppressive therapy.

People with primary immunodeficiency