Immune Biomarkers of Outcome From COVID-19 (IBOC)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Peripheral blood sampling

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • University Hospitals Plymouth NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with confirmed COVID-19 infection who are inpatients

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality	Day 4 and Day 10
Disease severity	Sequential Organ Failure Assessment (SOFA) score (range 0-24; higher score predicts worse outcome)	Day 4, 10 and 28

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Principal Investigator: Ashwin D Dhanda, MRCP PhD, University Hospitals Plymouth NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Actual): June 14, 2021
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: biomarker; inflammation; immune response
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20/HEP/381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study findings will be reported but IPD is not planned to be shared.

Drug and device information, study documents

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