+1. In this randomized trial, in patients with severe COVID-19 pneumonia and biochemical evidence of hyperinflammation, there was no significant difference in the proportion of patients requiring mechanical ventilation at day 15 following treatment initiation between patients who received anakinra plus standard of care (SoC) versus only SoC.
+COVID-19 has resulted in millions of cases worldwide, and multiple variants of SARS-CoV-2 have emerged. Most people experience mild symptoms, but a substantial portion can be critically ill; a subgroup of patients with severe COVID-19 show hyperinflammatory features, with increased circulating levels of cytokines, which are associated with poor outcomes. Anakinra is a recombinant IL-1 receptor antagonist, and evidence from retrospective and prospective studies has found improvement in mortality and mechanical ventilation in patients with COVID-19. This multicenter, randomized, open-label, phase 2/3 clinical trial was designed to assess the clinical outcomes of Anakinra with standard of care (SoC) versus SoC alone in patients with severe COVID-19 pneumonia. Adult patients with confirmed severe COVID-19 pneumonia and evidence of hyperinflammation were recruited from 12 hospitals in Spain between May 2020 and March 2021. Participants were randomly assigned to receive SoC plus anakinra or SoC alone in a 1:1 ratio, and the primary outcome studied was the proportion of patients not requiring mechanical ventilation 15 days after treatment initiation. In total, 161 patients were included in the final analysis, with 83 (52%) patients in the anakinra group and 78 patients in the SoC group (48%). With respect to the primary outcome, the proportion of patients not requiring mechanical ventilation up to day 15 in the anakinra group was not different from that in the SoC group (77.1% vs 85.9%; RR, 0.90; 95% CI 0.77-1.04; P=.16). In addition, there was no significant difference between groups in the proportion of patients requiring invasive mechanical ventilation up to day 15 (P>.99), nor any difference between the groups in the time to mechanical ventilation (P=.14). There was also no difference in the proportion of patients requiring ICU admission up to day 15, and no difference in the length of ICU stay between the two groups. Overall, the findings from this study suggest that the use of anakinra together with SoC does not prevent the need for mechanical ventilation or reduce mortality risk compared with SoC alone in hospitalized patients with severe COVID-19 pneumonia and evidence of hyperinflammation. A major limitation of this study was its open-label design, allowing for confounding factors such as the differential use of cointerventions. This study is an important step in studying medications that may be beneficial in patients with hyperinflammation, specifically due to severe COVID-19 pneumonia.
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