Status:
WITHDRAWN
The Role of Adaptive Immunity in COVID-19 Associated Myocardial Injury
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
Queen Mary University of London
Conditions:
Cardiovascular Disease Acute
Cardiomyopathies
Eligibility:
All Genders
18+ years
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 14 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04340921
Start Date
May 14 2020
End Date
April 14 2023
Last Update
April 21 2023
Active Locations (1)
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1
Barts Health Nhs Trust
London, United Kingdom, EC1A 7BE