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

NCT04340921 | Withdrawn

• 1 other identifier: 282289
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Acute; Cardiomyopathies; COVID

Outcome Measures

Primary Outcomes (1)

• T-cell immunophenotype

  T-cell immunophenotype

  12 months from enrollment

Secondary Outcomes (3)

• Mortality

  12 months from enrolment

• ITU admission

  12 months from enrolment

• Myocardial injury

  12 months from enrolment

Study Arms (3)

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

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

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

Interventions

COVID-19 exposure BIOLOGICAL

Observation only

1. COVID-19+ (n=120); 2. COVID-19+ Myocardial injury+ (n=20); 3. COVID-19+ Complication+ (estimated 10-25%)

Eligibility Criteria

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

Study Population

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

You may not qualify if:

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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Queen Mary University of London: collaborator

Study Sites (1)

Barts Health Nhs Trust

London, EC1A 7BE, United Kingdom

Location

Related Publications (12)

• Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4.

  PMID: 32129518 BACKGROUND

• Ramchand J, Patel SK, Srivastava PM, Farouque O, Burrell LM. Elevated plasma angiotensin converting enzyme 2 activity is an independent predictor of major adverse cardiac events in patients with obstructive coronary artery disease. PLoS One. 2018 Jun 13;13(6):e0198144. doi: 10.1371/journal.pone.0198144. eCollection 2018.

  PMID: 29897923 BACKGROUND

• Cooper LT Jr. Myocarditis. N Engl J Med. 2009 Apr 9;360(15):1526-38. doi: 10.1056/NEJMra0800028.

  PMID: 19357408 BACKGROUND

• Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

  PMID: 32192578 BACKGROUND

• Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.

  PMID: 32125452 RESULT

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 RESULT

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 RESULT

• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

  PMID: 32031570 RESULT

• Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.

  PMID: 32139904 RESULT

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 RESULT

• Komarowska I, Coe D, Wang G, Haas R, Mauro C, Kishore M, Cooper D, Nadkarni S, Fu H, Steinbruchel DA, Pitzalis C, Anderson G, Bucy P, Lombardi G, Breckenridge R, Marelli-Berg FM. Hepatocyte Growth Factor Receptor c-Met Instructs T Cell Cardiotropism and Promotes T Cell Migration to the Heart via Autocrine Chemokine Release. Immunity. 2015 Jun 16;42(6):1087-99. doi: 10.1016/j.immuni.2015.05.014. Epub 2015 Jun 9.

  PMID: 26070483 RESULT

• Bajaj R, Sinclair HC, Patel K, Low B, Pericao A, Manisty C, Guttmann O, Zemrak F, Miller O, Longhi P, Proudfoot A, Lams B, Agarwal S, Marelli-Berg FM, Tiberi S, Cutino-Moguel T, Carr-White G, Mohiddin SA. Delayed-onset myocarditis following COVID-19. Lancet Respir Med. 2021 Apr;9(4):e32-e34. doi: 10.1016/S2213-2600(21)00085-0. Epub 2021 Feb 19. No abstract available.

  PMID: 33617781 DERIVED

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sam (Saidi) Mohiddin, MD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

• Federica Marelli-Berg, PhD

  Queen Mary University of London

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 10, 2020
• Study Start: May 14, 2020
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)