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

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ClinicalTrials.gov Identifier: NCT04340921
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
Barts & The London NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiovascular Disease Acute Cardiomyopathies COVID Biological: COVID-19 exposure

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.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Adaptive Immunity in COVID-19 Associated Myocardial Injury
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : November 10, 2021
Estimated Study Completion Date : November 10, 2021

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




Primary Outcome Measures :
  1. T-cell immunophenotype [ Time Frame: 12 months from enrollment ]
    T-cell immunophenotype


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 12 months from enrolment ]
    death, survival to discharge

  2. ITU admission [ Time Frame: 12 months from enrolment ]
    Admission to the intensive care

  3. Myocardial injury [ Time Frame: 12 months from enrolment ]
    Defined by troponin rise to >99th centile



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients ≥18 years old admitted to the Barts NHS Trust who have a diagnosis of COVID-19.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340921


Contacts
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Contact: Daniel E Harding, BM BCh 020 7377 7000 d.harding@qmul.ac.uk
Contact: Sam (Saidi) Mohiddin, MD saidi.mohiddin@nhs.net

Locations
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United Kingdom
Barts Health Nhs Trust Recruiting
London, United Kingdom, EC1A 7BE
Contact: Saidi A Mohiddin, MD         
Sponsors and Collaborators
Barts & The London NHS Trust
Queen Mary University of London
Investigators
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Principal Investigator: Sam (Saidi) Mohiddin, MD Barts & The London NHS Trust
Study Chair: Federica Marelli-Berg, PhD Queen Mary University of London
Publications of Results:

Other Publications:
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT04340921    
Other Study ID Numbers: 282289
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared from this project.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Cardiomyopathies
Heart Diseases