Abstract
Objectives: Severe COVID-19 is associated with an imbalanced immune response. We hypothesized that patients with enhanced inflammation, as demonstrated by increased levels of certain inflammatory biomarkers, would benefit from interleukin-6 blockage.
Methods: Patients hospitalized with COVID-19, hypoxemia, and at least two of four markedly elevated markers of inflammation (interleukin-6, C-reactive protein, ferritin, and/or D-dimer) were randomized for tocilizumab (TCZ) plus standard of care (SoC) or SoC alone. The primary endpoint was clinical status at day 28 assessed using a seven-category ordinal scale, and the secondary endpoints included intensive care unit admission, respiratory support, and duration of hospital admission.
Results: Clinical status at day 28 was significantly better in patients who received TCZ in addition to SoC compared with those who received SoC alone (p = 0.037). By then, 93% of patients who received TCZ (n = 53 of 57) and 86% of control patients (n = 25 of 29) had been discharged from the hospital. In addition, 47% of TCZ patients (n = 27 of 57) and 24% of control patients (n = 7 of 29) had resumed normal daily activities. The median length of hospitalization was 9 days (interquartile range, 7-12) in the TCZ group and 12 days (interquartile range, 9-15) in the control group (p = 0.014).
Discussion: In patients hospitalized with COVID-19, hypoxemia, and elevated inflammation markers, administration of TCZ in addition to SoC was associated with significantly better clinical recovery by day 28 and a shorter hospitalization compared with SoC alone.
Keywords: COVID-19; Hospitalization; Interleukin-6; SARS-CoV-2; Tocilizumab.
【저자키워드】 COVID-19, SARS-CoV-2, Hospitalization, interleukin-6, tocilizumab., 【초록키워드】 Inflammation, immune response, Hospitalized, intensive care, severe COVID-19, Tocilizumab, hospital, interleukin-6, C-reactive protein, D-dimer, ferritin, clinical status, clinical recovery, Randomized, interleukin, clinical, Hypoxemia, Patient, Hospital admission, respiratory, Admission, inflammation markers, inflammatory biomarkers, marker, intensive care unit admission, Ordinal Scale, administration, primary endpoint, Respiratory Support, Standard of care, interquartile range, (interleukin-6, control group, secondary endpoint, Secondary endpoints, control patients, activities, seven-category ordinal scale, SOC, benefit, significantly, addition, elevated, median, demonstrated, discharged, control patient, patients hospitalized, TCZ, with COVID-19, 【제목키워드】 Open-label, Randomized, hospitalized COVID-19 patient, administration, Inflammatory, elevated,