TABLE 1.
Key inclusion and exclusion criteria
| Inclusion criteria |
| Hospitalized due to Covid‐19 infection with positive Covid‐19 test within 5 days of enrollment |
| Documented SARS‐CoV2 acute myocardial injury: Defined as upper respiratory tract specimen positive for Covid‐19 AND troponin greater than 99% upper reference range without signs or symptoms of acute myocardial ischemia |
| NT‐proBNP or BNP greater than upper reference limit |
| Receiving current standard therapy |
| C‐reactive protein (CRP) > 50 mg/L |
| Exclusion criteria |
| Alternative explanation for troponin elevation (Type I or Type II MI according to fourth Universal Definition of Myocardial Infarction, which in addition to a rise and fall of troponin above the 99% upper reference limit, includes symptoms of acute myocardial ischemia, new ischemic ECG changes, development of pathologic Q waves, and imaging evidence of damage in a pattern consistent with an ischemic etiology) |
| Chronic Systolic Heart Failure with EF < 35% |
| Age < 18 years‐old |
| Uncontrolled systemic bacterial or fungal infection |
| Concomitant viral infection (eg, Influenza or other respiratory virus) |
| Pregnant. Breast‐feeding women are eligible with the decision to continue or discontinue breast‐feeding during therapy taking into account the risk of infant exposure, the benefits of breast‐feeding to the infant, and benefits of treatment to the mother. |
| On mechanical circulatory support |
| On mechanical ventilation for greater than 48 hours |
| Resuscitated cardiac arrest |
| Has a known hypersensitivity to canakinumab or any of its excipients |
| Neutrophil count <1000/mm3 |
| Has a history of myeloproliferative disorder or active malignancy receiving chemotherapy |
| Known active tuberculosis or history of incompletely treated tuberculosis |
| Current treatment with immunosuppressive agents |
| Chronic prednisone use >10 mg/daily (for more than 3 weeks prior to admission) |
| Has a history of solid‐organ or bone marrow transplant |
| Severe preexisting liver disease with clinically significant portal hypertension |
| End‐stage renal disease on chronic renal replacement therapy |
| Enrollment in another investigational study using immunosuppressive therapy |
| In the opinion of the investigator and clinical team, should not participate in the study |
| If male and sexually active, must have documented vasectomy or must practice birth control and not donate sperm during the study and for 3 months after study drug administration. |
| Women of child‐bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug. Such methods include: |
| Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception |
| Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment |
| Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject |
| Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception |
Abbreviations: COVID‐19, coronavirus disease 2019; EF, ejection fraction; SARS‐CoV2, severe acute respiratory syndrome coronavirus 2.