2.1. Study Design and Participants
COVID-19 PNEUMONIA, SARS-COV-2 INFECTION
This double-blind, randomized, placebo-controlled trial was conducted at a large, urban academic medical center. The trial was approved by the University of Alabama at Birmingham (UAB) Institutional Review Board and was conducted in accordance with Good Clinical Practice guidelines. All patients provided written informed consent consistent with the institutional guidelines. The investigators designed the clinical trial, collected all the data, and performed the analysis. The UABSOM COVID-19 Research Initiative and Swedish Orphan Biovitrum (SOBI) funded the trial and provided anakinra and placebo, respectively, but had no role in data analysis, data interpretation, or writing of the original manuscript. The trial was registered with ClinicalTrials.gov, NCT04362111. Patients were eligible for enrollment if they had nucleic acid- (PCR RNA) confirmed SARS-CoV-2 infection, mild-to-moderate COVID-19 pneumonia based on imaging, new or increasing oxygen requirement to maintain oxygen saturation greater than 93%, and serum ferritin level greater than 700 ng/mL. Patients had to have at least three of the following additional criteria: elevated D-dimer more than 500 ng/mL, platelet count less than 130,000/mm