Covid19LITCOMENCT06879548
Bedside Assessment of Immune Function in Patients With Covid-19
An observational study of Covid19, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Covid-19 is a global pandemic causing unprecedented morbidity and mortality in the general population. It appears to have a greater effect on the elderly or those with underlying health problems but is not exclusively confined to these groups. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2021to Sep 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients passing through A\&E with Covid-19 requiring admission to hospital without fulfilling the exclusion criteria will be potential recruits to the study.
Who may be able to join
- Over 18y age Suspected diagnosis of Covid-19 Able to give written informed consent
Who cannot join
- Unwilling or unable to give consent Under 18years of age Suffering from other acute septic/infective illness other than Covid-19
Trial locations and contacts
1 site in 1 country.
About this study
Covid-19 is a global pandemic causing unprecedented morbidity and mortality in the general population. It appears to have a greater effect on the elderly or those with underlying health problems but is not exclusively confined to these groups. As people age, particularly toward the end of their lives, the response of the immune system begins to drop away, an occurrence known as immunosenescence. It is known that there exist a group of people that do not respond to immune stimulation in a normal way but who may to observers be considered fit and healthy. The leukocyte immune test (LIT) relies upon the supramaximal stimulation of white cells outside of the body to determine their reactiveness when stimulated. It is intended to study patients admitted to Barts Health with diagnosed Covid-19. 4 ml blood will be taken of which 10microlitres will be used for the LIT. The remainder will be used for measurement of antibody levels previously associated with poor outcome following cardiac surgery. The patients will be followed up to see the proportion that progress to requirement for critical care, advanced ventilatory support, renal failure and in-hospital mortality. If a link can be established between a poor outcome following admission to hospital with Covid-19 and the immune response on admission, as predicted by means of the LIT, then it may enable better formulation of potential treatment strategies. Being able to measure at point of admission the responsiveness of someone's immune system may mean that treatment strategies such as the administration of passive immunization either via convalescent plasma or gammaglobulin will be better guided. If the LIT proves able to identify those people at risk of severe disease it may be able to identify individuals amongst healthcare workers that may benefit from passive immunisation or avoidance of high-risk exposure to Covid-19.
- Conditions
- Covid19
- Keywords
- Immune, Neutrophil, Covid 19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Review point of care test of immune function at admission relate to progression of disease
Whether the result from a point of care test of immune function at admission relates to progression of disease requiring intensive care admission in hospitalised Covid-19 patients.
Measured: From admission date to discharge date.
Secondary outcomes (5)
Review LIT result at admission relate to requirement for respiratory support
Whether the LIT result at admission relates to the requirement for respiratory support
Measured: Throughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relate to requirement for renal replacement therapy
Whether the LIT result at admission relates to the requirement for renal replacement therapy
Measured: Throughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relate to length of admission
Measured: Throughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relates to all cause in-hospital mortality
Whether the LIT result at admission relates to all cause in-hospital mortality
Measured: Throughout patient hospital stay (admission date to discharge date).
Review the LIT result at admission relates to previously measured immune markers of associated with outcome, namely EndoCAb.
Whether the LIT result at admission relates to previously measured immune markers of associated with outcome, namely EndoCAb.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start11 Mar 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Study team moved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin Hamilton-Davies, Principal investigator, Barts Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879548
- Sponsor's protocol ID
- 282113
- Acronym
- LITCOME
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2021
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Assessment of Immune Function in Patients With Covid-19
- ClinicalTrials.gov ID
- NCT06879548
- Acronym / sponsor ID
- LITCOME / 282113
- Conditions
- Covid19
- Keywords
- Immune, Neutrophil, Covid 19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study team moved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 11 Mar 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 17 Mar 2025 (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.
Covid-19 is a global pandemic causing unprecedented morbidity and mortality in the general population. It appears to have a greater effect on the elderly or those with underlying health problems but is not exclusively confined to these groups. As people age, particularly toward the end of their lives, the response of the immune system begins to drop away, an occurrence known as immunosenescence. It is known that there exist a group of people that do not respond to immune stimulation in a normal way but who may to observers be considered fit and healthy. The leukocyte immune test (LIT) relies upon the supramaximal stimulation of white cells outside of the body to determine their reactiveness when stimulated. It is intended to study patients admitted to Barts Health with diagnosed Covid-19. 4 ml blood will be taken of which 10microlitres will be used for the LIT. The remainder will be used for measurement of antibody levels previously associated with poor outcome following cardiac surgery. The patients will be followed up to see the proportion that progress to requirement for critical care, advanced ventilatory support, renal failure and in-hospital mortality. If a link can be established between a poor outcome following admission to hospital with Covid-19 and the immune response on admission, as predicted by means of the LIT, then it may enable better formulation of potential treatment strategies. Being able to measure at point of admission the responsiveness of someone's immune system may mean that treatment strategies such as the administration of passive immunization either via convalescent plasma or gammaglobulin will be better guided. If the LIT proves able to identify those people at risk of severe disease it may be able to identify individuals amongst healthcare workers that may benefit from passive immunisation or avoidance of high-risk exposure to Covid-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients passing through A\&E with Covid-19 requiring admission to hospital without fulfilling the exclusion criteria will be potential recruits to the study.
Key inclusion criteria (1 listed)
- Over 18y age Suspected diagnosis of Covid-19 Able to give written informed consent
Key exclusion criteria (1 listed)
- Unwilling or unable to give consent Under 18years of age Suffering from other acute septic/infective illness other than Covid-19
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
Review point of care test of immune function at admission relate to progression of disease
Time frame: From admission date to discharge date.
Whether the result from a point of care test of immune function at admission relates to progression of disease requiring intensive care admission in hospitalised Covid-19 patients.
5 secondary outcomes
Review LIT result at admission relate to requirement for respiratory support
Time frame: Throughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relate to requirement for renal replacement therapy
Time frame: Throughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relate to length of admission
Time frame: Throughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relates to all cause in-hospital mortality
Time frame: Throughout patient hospital stay (admission date to discharge date).
Review the LIT result at admission relates to previously measured immune markers of associated with outcome, namely EndoCAb.
Time frame: At 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Colin Hamilton-Davies principal investigator
Barts Health
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 Covid19, run by Barts & The London 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 1 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: withdrawn, as of the sponsor's last update on 17 Mar 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Review point of care test of immune function at admission relate to progression of disease (time frame: From admission date to discharge date.). 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 17 Mar 2025.