Abstract Background In 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. Hypothesis The primary hypothesis is that canakiumab will shorten time to recovery. Methods The 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. Results Baseline 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. Conclusions The 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.
【저자키워드】 COVID‐19, SARS‐CoV‐2, myocardial injury, canakinumab, 【초록키워드】 Randomized controlled trial, Treatment, Inflammation, Hospitalized, Respiratory failure, Mortality, randomization, hospital, CRP, troponin, outcome, hypertension, discharge, Prevalence, cardiac injury, myocardial injury, Characteristics, morbidity, male, Patient, Controlled trial, troponin T, Placebo, morbidity and mortality, Time to recovery, canakinumab, Ordinal Scale, Hypothesis, primary endpoint, cardiac, SARS‑CoV2, dysfunction, secondary endpoint, baseline characteristics, worsening, Elevation, SARS‐CoV2 infection, C‐reactive protein, elevations, progressive respiratory failure, hyperlipidemia, hospitalized COVID‐19 patients, Prevent, Seven, IMPROVE, Result, enrolled, defined, evaluate, elevated, median, occur, anticipated, randomized patient, 【제목키워드】 Inflammation, Respiratory function, SARS‐CoV‐2, Deterioration, reduce,