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Bedside Assessment of Immune Function in Patients With Covid-19

Bedside Assessment of Immune Function in Patients With Covid-19

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06879548
Acronym
LITCOME
Enrollment
0
Registered
2025-03-17
Start date
2021-03-11
Completion date
2023-09-30
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Immune, Neutrophil, Covid 19

Brief 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. 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.

Interventions

None listed

Sponsors

Barts & The London NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Over 18y age Suspected diagnosis of Covid-19 Able to give written informed consent

Exclusion criteria

* Unwilling or unable to give consent Under 18years of age Suffering from other acute septic/infective illness other than Covid-19

Design outcomes

Primary

MeasureTime frameDescription
Review point of care test of immune function at admission relate to progression of diseaseFrom 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.

Secondary

MeasureTime frameDescription
Review LIT result at admission relate to requirement for respiratory supportThroughout patient hospital stay (admission date to discharge date).Whether the LIT result at admission relates to the requirement for respiratory support
Review LIT result at admission relate to requirement for renal replacement therapyThroughout patient hospital stay (admission date to discharge date).Whether the LIT result at admission relates to the requirement for renal replacement therapy
Review LIT result at admission relate to length of admissionThroughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relates to all cause in-hospital mortalityThroughout patient hospital stay (admission date to discharge date).Whether the LIT result at admission relates to all cause in-hospital mortality
Review the LIT result at admission relates to previously measured immune markers of associated with outcome, namely EndoCAb.At 6 monthsWhether the LIT result at admission relates to previously measured immune markers of associated with outcome, namely EndoCAb.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026