1. Introduction
hypoxemic respiratory failure, death, pneumonia, respiratory illness coronavirus disease 2019
DISEASE PROGRESSION, PNEUMONIA, SARS-COV-2 INFECTION, COVID-19 PNEUMONIA, DISEASE, INFLAMMATION, SYNDROME, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME, COMPLICATIONS, HYPOXEMIC RESPIRATORY FAILURE
(1) Background: Some severe COVID-19 patients develop hyperinflammatory cytokine storm syndrome (CSS). We assessed the efficacy of anakinra added to standard of care (SoC) in hospitalized COVID-19 CSS patients. (2) Methods: In this single-center, randomized, double-blind, placebo-controlled trial (NCT04362111), we recruited adult hospitalized patients with SARS-CoV-2 infection, evidence of pneumonia, new/increasing oxygen requirement, ferritin ≥ 700 ng/mL, and at least three of the following indicators: D-dimer ≥ 500 ng/mL, platelet count < 130,000/mmThe respiratory illness coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induces a moderate to severe disease requiring hospital admission and supplemental oxygen support in approximately 10–15% of patients [Thus far, data on the efficacy of anakinra in patients with COVID-19-associated CSS have been largely driven by observational studies [The objective of this investigator-initiated randomized, double-blind, placebo-controlled trial was to assess the efficacy and safety of anakinra when added to usual care for the treatment of CSS in patients with COVID-19 pneumonia to prevent disease progression and complications. We hypothesized that early intervention with interleukin-1 receptor blockade might limit the progression to hypoxemic respiratory failure, requiring intubation and mechanical ventilation, or death, reduce the risk of clinical worsening, improve markers of inflammation, and decrease the supplemental oxygen requirement. 