The Role of Adaptive Immunity in COVID-19 Associated Myocardial Injury

April 19, 2023 updated by: Barts & The London NHS Trust
COVID-19 is associated with complications including ARDS and myocardial injury, which informs prognosis and patient outcome. The laboratory plans to perform immunophenotyping of peripheral T-cells in patients with COVID-19 and complications (ARDS, ITU admission, myocardial injury) and map this against clinical patient outcomes. The aim is to determine if there is a specific T-cell immunophenotype associated with COVID-19 and/or complications, which can be used to inform prognosis and potential therapies.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Infection with the novel coronavirus COVID-19 is designated a pandemic by the World Health Organisation (WHO).COVID-19 infection can result in severe lung inflammation which, when present, dominates the clinical course for most patients. However, other organs may also be involved and the cardiovascular (CV) system appears to have complex interactions with COVID-19. Published reports suggest evidence of heart muscle damage in 20-40% of hospitalised cases presenting as cardiac chest pain, heart failure, abnormal heart rhythms and cardiac death.

Many affected were previously well, but approximately half of those admitted to hospital COVID-19 have other medical problems, increasing in those requiring ITU admission or those that died. Patients with pre-existing CV conditions have some of the worst outcomes. Although pre-existing disorders reduce an individual's capacity to withstand severe illness, it is also likely that CV diseases may increase the risk of developing complicated COVID-19 disease. Our hypothesis is that immunological abnormalities acquired as a consequence of pre-existing disorders is responsible for this.

A question central to potential therapeutic options is the extent to which COVID-19 related myocardial injury results from viral replication (cytopathic), is immune mediated or is due to other mechanisms. Given that rapid onset cardiac injury can occur at 7-14 days after onset of COVID symptoms we propose to evaluate the contribution of adaptive T-cell mediated immunity in patients with and without myocardial injury. If successful, we may be able to identify treatments that suppress discrete components of the immune system to prevent myocardial damage without depressing protective immune function.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients ≥18 years old admitted to the Barts NHS Trust who have a diagnosis of COVID-19.

Description

Group 1: COVID-19 positive without evidence of myocardial injury (n=120). Inclusion criteria: All adult (age≥18 but <100 years of age) inpatients with confirmed COVID-19 infection. Exclusion criteria: No biochemical evidence of acute myocardial injury (serum troponin>99th centile within previous 48-hour period)

Group 2: COVID-19 positive with myocarditis (n=20). Inclusion criteria: All adult (age≥18 but <100 years of age) inpatients with confirmed COVID-19 infection and clinically suspected or confirmed myocarditis including evidence of acute myocardial injury (troponin >99th centile within the previous 48-hour period) at the time of recruitment.

Exclusion criteria: significant chronic kidney disease (eGFR ≤30 or dialysis-dependent) or septic shock at the time of initial assessment. We will also exclude patients with a diagnosis of chronic heart muscle disease and those with known significant chronic or acute obstructive coronary disease.

Group 3: Group 1 and 2 study participants with a complicated course (estimated 14-35 patients).

Inclusion criteria: Participants form Groups 1 and 2 in whom a prespecified complication ocurs will be included in a derived Group3.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1. COVID-19+ (n=120)

COVID-19 positive without evidence of myocardial injury (n=120). Inclusion criteria: All adult (age≥18 but <100 years of age) inpatients with confirmed COVID-19 infection.

Exclusion criteria: No biochemical evidence of acute myocardial injury (serum troponin>99th centile within previous 48-hour period).
Biological: COVID-19 exposure
Observation only
2. COVID-19+ Myocardial injury+ (n=20)

COVID-19 positive with myocarditis (n=20). Inclusion criteria: All adult (age≥18 but <100 years of age) inpatients with confirmed COVID-19 infection and clinically suspected or confirmed myocarditis including evidence of acute myocardial injury (troponin >99th centile within the previous 48-hour period) at the time of recruitment.

Exclusion criteria: significant chronic kidney disease (eGFR ≤30 or dialysis-dependent) or septic shock at the time of initial assessment. We will also exclude patients with a diagnosis of chronic heart muscle disease and those with known significant chronic or acute obstructive coronary disease.
Biological: COVID-19 exposure
Observation only
3. COVID-19+ Complication+ (estimated 10-25%)
Inclusion criteria: Participants form Groups 1 and 2 in whom a prespecified complication ocurs will be included in a derived Group3.
Biological: COVID-19 exposure
Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-cell immunophenotype
Time Frame: 12 months from enrollment
T-cell immunophenotype
12 months from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months from enrolment
death, survival to discharge
12 months from enrolment
ITU admission
Time Frame: 12 months from enrolment
Admission to the intensive care
12 months from enrolment
Myocardial injury
Time Frame: 12 months from enrolment
Defined by troponin rise to >99th centile
12 months from enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

Queen Mary University of London

Investigators

  • Principal Investigator: Sam (Saidi) Mohiddin, MD, Barts & The London NHS Trust
  • Study Chair: Federica Marelli-Berg, PhD, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2020

Primary Completion (Actual)

April 14, 2023

Study Completion (Actual)

April 14, 2023

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared from this project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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