Subjects will not be eligible if they meet any one of the following exclusion criteria |
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1. Age < 21 years; |
2. Pregnancy; |
3. Inability to obtain consent from patient or legally authorized representative; |
4. Contraindications to treatment with Anakinra (Kineret)(i.e. prior allergic reaction to the drug or to E. coli derived products or severe allergy to latex); |
5. Severe anemia (Hgb < 8 g/dl—due to the need of more frequent blood sampling with this study) |
6. Acute or chronic active infections (not including treated/cured HCV with negative viral load) |
7. Acute or chronic inflammatory disease or immunosuppressive therapies (excluding stable [> 1 month] oral corticosteroids at a dose of prednisone less than 0.5 mg/kg/day or methotrexate) |
8. Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent from complying with study instructions; |
9. Limited English Proficiency that in the opinion of the investigator may prevent from understanding the content of the informed consent form or safely completing the study procedures |
10. Live vaccination within the prior month |
11. Neutropenia (defined as absolute neutrophil count < 1,500/ml or < 1,000/ml if subject is African American) |
12. History of malignancy within the prior 5Â years (with exception of basal cell skin cancer, carcinoma in-situ of the cervix or low risk prostate cancer after curative therapy) |
13. Participation in another concurrent intervention study within 30Â day or treatment with an investigational drug within 5 half-lives prior to randomization |
14. Severe kidney disease (GFR < 30 mL/min/1.73m2) |
15. Evidence of COVID-19 within the last 60Â days or recent (21Â days) exposure to close personal contact with COVID-19 |
16. Chronic, moderate-to-severe kidney disease (GFR < 60 mL/min/1.73m2) or acute kidney injury, or history of severe hypersensitivity reactions to gadolinium-based contrast agents—for VCU Imaging Sub-study, patients may participate but will not undergo CMR |