COVID-19IBOCNCT04436484
Immune Biomarkers of Outcome From COVID-19
An observational study of COVID-19, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
A new virus to humans, first identified in December 2019, is causing a global pandemic with over 1 million infections and many thousands of deaths. The virus, SARS-CoV2, leads to coronavirus disease 2019 (COVID-19), which mainly affects the breathing system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Peripheral blood sampling
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2020to 14 Jun 2021
- 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
- Adult, Older adult
Study population: People with confirmed COVID-19 infection who are inpatients
Who may be able to join
- Patients attending UHP with COVID-19 infection
- Participants capable of giving informed consent, or if not capable, assent from a personal or nominated consultee
- Age of 18 or over
- Confirmed COVID-19 infection by PCR or antibody testing
Who cannot join
- Participants on immune suppressing medications within preceding 4 weeks (including systemic corticosteroids with average daily dose equivalent to prednisolone 20 mg)
- Participants on treatment with systemic chemotherapy
- Participants with known immunodeficiency states
- Participants already administered immunomodulating or antiviral agents as part of an interventional trial (this does not include non-specific therapies such as hydroxycholoroquine)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Plymouth NHS Trust
Plymouth, Devon, PL6 8DH
About this study
Official title: Immune Dysfunction in COVID-19: Investigation of Mechanisms and Identification of Immune Biomarkers of Clinical Outcome
A new virus to humans, first identified in December 2019, is causing a global pandemic with over 1 million infections and many thousands of deaths. The virus, SARS-CoV2, leads to coronavirus disease 2019 (COVID-19), which mainly affects the breathing system. Around 1 in every 5 people with COVID-19 have more severe infection needing treatment in hospital. Up to half of them require help with breathing in an intensive care unit. Information we have so far about COVID-19 suggests that people with underlying conditions, such as high blood pressure and heart disease, or older people are at higher risk of having severe illness. Scientists do not yet understand why but think it may be related to the immune system.
SARS-CoV2 activates the immune system causing inflammation in the lungs, which is also seen in circulating immune cells in the blood. Preliminary reports show that the response of the immune system can be inappropriate, both overactive and also poorly responsive (exhausted). Changes in the type and function of immune cells have been linked to increased risk of severe disease or death from COVID-19.
In this study, the investigators will look for markers of immune function when a person first attends hospital, which can be used to predict whether they will go on to have a more severe infection. This will help treat patients more effectively, for example, by moving high risk patients to an intensive care setting at an early stage. The team will investigate the immune system in detail in 200 patients with COVID-19 attending University Hospitals Plymouth. The investigators will look for changes in the number, type and function of circulating immune cells and measure whether these changes are linked to severity of the infection or death. The investigators will use established techniques to measure immune function that could be rapidly put into routine hospital care to help guide treatment for individual patients.
- Conditions
- COVID-19
- Being tested
- Peripheral blood sampling
- Keywords
- inflammation, immune response, biomarker
- Medical subject headings
- COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood samplingDiagnostic test
Non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality
Measured: up to 28 days
Secondary outcomes (2)
Mortality
Mortality
Measured: Day 4 and Day 10
Disease severity
Sequential Organ Failure Assessment (SOFA) score (range 0-24; higher score predicts worse outcome)
Measured: Day 4, 10 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start29 Apr 2020
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashwin D Dhanda, MRCP PhD, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436484
- Sponsor's protocol ID
- 20/HEP/381
- Acronym
- IBOC
- Status last verified
- Oct 2021
- First submitted
- 12 Jun 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study findings will be reported but IPD is not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Dysfunction in COVID-19: Investigation of Mechanisms and Identification of Immune Biomarkers of Clinical Outcome
- ClinicalTrials.gov ID
- NCT04436484
- Acronym / sponsor ID
- IBOC / 20/HEP/381
- Conditions
- COVID-19
- Keywords
- inflammation, immune response, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 18 Jun 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.
A new virus to humans, first identified in December 2019, is causing a global pandemic with over 1 million infections and many thousands of deaths. The virus, SARS-CoV2, leads to coronavirus disease 2019 (COVID-19), which mainly affects the breathing system. Around 1 in every 5 people with COVID-19 have more severe infection needing treatment in hospital. Up to half of them require help with breathing in an intensive care unit. Information we have so far about COVID-19 suggests that people with underlying conditions, such as high blood pressure and heart disease, or older people are at higher risk of having severe illness. Scientists do not yet understand why but think it may be related to the immune system.
SARS-CoV2 activates the immune system causing inflammation in the lungs, which is also seen in circulating immune cells in the blood. Preliminary reports show that the response of the immune system can be inappropriate, both overactive and also poorly responsive (exhausted). Changes in the type and function of immune cells have been linked to increased risk of severe disease or death from COVID-19.
In this study, the investigators will look for markers of immune function when a person first attends hospital, which can be used to predict whether they will go on to have a more severe infection. This will help treat patients more effectively, for example, by moving high risk patients to an intensive care setting at an early stage. The team will investigate the immune system in detail in 200 patients with COVID-19 attending University Hospitals Plymouth. The investigators will look for changes in the number, type and function of circulating immune cells and measure whether these changes are linked to severity of the infection or death. The investigators will use established techniques to measure immune function that could be rapidly put into routine hospital care to help guide treatment for individual patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with confirmed COVID-19 infection who are inpatients
Key inclusion criteria (4 listed)
- Patients attending UHP with COVID-19 infection
- Participants capable of giving informed consent, or if not capable, assent from a personal or nominated consultee
- Age of 18 or over
- Confirmed COVID-19 infection by PCR or antibody testing
Key exclusion criteria (4 listed)
- Participants on immune suppressing medications within preceding 4 weeks (including systemic corticosteroids with average daily dose equivalent to prednisolone 20 mg)
- Participants on treatment with systemic chemotherapy
- Participants with known immunodeficiency states
- Participants already administered immunomodulating or antiviral agents as part of an interventional trial (this does not include non-specific therapies such as hydroxycholoroquine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood samplingNon-interventional study | Diagnostic test | – |
Primary outcome
Mortality
Time frame: up to 28 days
Mortality
2 secondary outcomes
Mortality
Time frame: Day 4 and Day 10
Disease severity
Time frame: Day 4, 10 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No. Study findings will be reported but IPD is not planned to be shared.
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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.
Ashwin D Dhanda, MRCP PhD principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: up to 28 days). 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 8 Oct 2021.