• Calvin C Sheng, Debasis Sahoo, Siddharth Dugar, Robier Aguillon Prada, WangTom Kai MingTKMDepartment of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA., Ossama K Abou Hassan, Danielle Brennan, Daniel A Culver, Prabalini Rajendram, Abhijit Duggal, A Michael Lincoff, Steven E Nissen, Venu Menon, and Paul C Cremer.
• Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.
• Clin Cardiol. 2020 Oct 1; 43 (10): 1055-1063.

BackgroundIn patients with Covid-19, myocardial injury and increased inflammation are associated with morbidity and mortality. We designed a proof-of-concept randomized controlled trial to evaluate whether treatment with canakinumab prevents progressive respiratory failure and worsening cardiac dysfunction in patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation.HypothesisThe primary hypothesis is that canakiumab will shorten time to recovery.MethodsThe three C study (canakinumab in Covid-19 Cardiac Injury, NCT04365153) is a double-blind, randomized controlled trial comparing canakinumab 300 mg IV, 600 mg IV, or placebo in a 1:1:1 ratio in hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP). The primary endpoint is defined as the time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14 days postrandomization. The secondary endpoint is mortality at day 28. A total of 45 patients will be enrolled with an anticipated 5 month follow up period.ResultsBaseline characteristics for the first 20 randomized patients reveal a predominantly male (75%), elderly population (median 67 years) with a high prevalence of hypertension (80%) and hyperlipidemia (75%). CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.ConclusionsThe three C study will provide insights regarding whether IL-1β inhibition may improve outcomes in patients with SARS-CoV2 associated myocardial injury and increased inflammation.© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.

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