Bedside Assessment of Immune Function in Patients With Covid-19 (LITCOME)

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 Overview

• Status: Withdrawn
• Conditions: Covid19

• Study Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E13 8SL
    • Newham University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From admission date to discharge date.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Review LIT result at admission relate to requirement for respiratory support	Whether the LIT result at admission relates to the requirement for respiratory support	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	Throughout patient hospital stay (admission date to discharge date).
Review LIT result at admission relate to length of admission		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	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.	At 6 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Investigators: Principal Investigator: Colin Hamilton-Davies, Barts Health

Study record dates

Study Major Dates

• Study Start (Estimated): March 11, 2021
• Primary Completion (Estimated): March 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Immune; Covid 19; Neutrophil
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 282113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No