Bedside Assessment of Immune Function in Patients With Covid-19

NCT ID: NCT06879548

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2023-09-30

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Hamilton-Davies

Role: PRINCIPAL_INVESTIGATOR

Barts Health

Locations

Newham University Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

282113

Identifier Type: -

Identifier Source: org_study_id