Immune Biomarkers of Outcome From COVID-19

NCT04436484 | Completed

• 1 other identifier: 20/HEP/381
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Keywords

inflammation; immune response; biomarker

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality

  up to 28 days

Secondary Outcomes (2)

• Mortality

  Day 4 and Day 10

• Disease severity

  Day 4, 10 and 28

Interventions

Peripheral blood sampling DIAGNOSTIC_TEST

Non-interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with confirmed COVID-19 infection who are inpatients

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashwin D Dhanda, MRCP PhD

  University Hospitals Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 18, 2020
• Study Start: April 29, 2020
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)