HIV-1-infectionCORIANCT04354818
Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (CORIA)
An observational study of HIV-1-infection and Cancer, run by Kirby Institute at 11 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, Cancer, Primary Immune Deficiency Disorder
- How many people
- 27 participants
- Where
- 11 sitesAustralia
- Study dates
- 11 May 2020to 27 Apr 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- Have one of the following conditions affecting immune function:
Show all 13Show fewer
- 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
- For optional biobanking only, ability to provide informed consent
Who cannot join
- Nil
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Australia11 sites
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
East Sydney Doctors
Sydney, New South Wales, 2010
Royal North Shore Hospital
Sydney, New South Wales, 2065
Blacktown Hospital
Sydney, New South Wales, 2148
Liverpool Hospital
Sydney, New South Wales, 2170
St George Hospital
Sydney, New South Wales, 2217
Concord Hospital
Sydney, New South Wales
Holdsworth House Medical Practice
Sydney, New South Wales
Melanoma Institute Australia
Sydney, New South Wales
Nepean Hospital
Sydney, New South Wales
Westmead Hospital
Sydney, New South Wales
About this study
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
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.
- Conditions
- HIV-1-infection, Cancer, Primary Immune Deficiency Disorder, Immunosuppression Disorders, COVID-19
- Medical subject headings
- Neoplasms, Primary Immunodeficiency Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV | Not described | |
| Recipients of Solid Organ Transplants | Not described | |
| People Living with Cancer | Not described | |
| People with acquired immunodeficiency | Patients with acquired immunodeficiency associated with other immunosuppressive therapy. | |
| People with primary immunodeficiency | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
Measured: Day 28
Secondary outcomes (1)
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start11 May 2020
- Primary completion27 Apr 2022 (estimated)
- Study completion27 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- St Vincent's Hospital, Sydney, Garvan Institute of Medical Research, Westmead Hospital, Blacktown Hospital, Sydney, Australia, Holdsworth House Medical Practice, Royal North Shore Hospital, Melanoma Institute Australia, Prince of Wales Hospital, Sydney, Gilead Sciences, Cancer Institute NSW, Cancer Council New South Wales, Positive Life NSW, St George Hospital, Australia, Liverpool Hospital, Sydney
- Responsible party
- Sponsor
- Investigators
- Mark Polizzotto, MD, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354818
- Sponsor's protocol ID
- 2020-04-CORIA
- Acronym
- CORIA
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04354818
- Acronym / sponsor ID
- CORIA / 2020-04-CORIA
- Conditions
- HIV-1-infection, Cancer, Primary Immune Deficiency Disorder, Immunosuppression Disorders, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- St Vincent's Hospital, Sydney, Garvan Institute of Medical Research, Westmead Hospital, Blacktown Hospital, Sydney, Australia, Holdsworth House Medical Practice, Royal North Shore Hospital, Melanoma Institute Australia, Prince of Wales Hospital, Sydney, Gilead Sciences, Cancer Institute NSW, Cancer Council New South Wales, Positive Life NSW, St George Hospital, Australia, Liverpool Hospital, Sydney
- Study start
- 11 May 2020 (actual)
- Primary completion
- 27 Apr 2022 (estimated)
- Study completion
- 27 Apr 2022 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| People living with HIV | – | – |
| Recipients of Solid Organ Transplants | – | – |
| People Living with Cancer | – | – |
| People with acquired immunodeficiency | – | –Patients with acquired immunodeficiency associated with other immunosuppressive therapy. |
| People with primary immunodeficiency | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Presenting (in person or via telemedicine) for evaluation because they:
- Have one of the following conditions affecting immune function:
- For optional biobanking only, ability to provide informed consent
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
Time frame: Day 28
1 secondary outcome
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Polizzotto, MD principal investigator
Kirby Institute
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and Cancer, run by Kirby Institute at 11 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients who required hospitalisation, developed severe illness (ICU admission) or died (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.