Clin Microbiol Infect. 2022 Mar 5:S1198-743X(22)00104-5. doi: 10.1016/j.cmi.2022.02.027. Online ahead of print.
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 IL-6 blockage.
METHODS: Hospitalized COVID-19 patients with hypoxemia and at least 2 out of 4 markedly elevated markers of inflammation (interleukin-6, CRP, ferritin and/or D-dimer) were randomized for tocilizumab plus standard of care or standard of care alone. Primary endpoint was clinical status at day 28 assessed using a 7-category ordinal scale and secondary endpoints included ICU admission, respiratory support, and duration of hospital admission.
RESULTS: Clinical status at day 28 was significantly better in patients who received tocilizumab in addition to standard of care in comparison to those who received standard of care alone (p=0.037). By then, 93% (53/57) patients who received tocilizumab and 86% (25/29) of control patients were discharged from the hospital. 47% (27/57) of tocilizumab patients and 24% (7/29) of control patients had resumed normal daily activities. The median hospitalization was 9 (quartiles 7-12) days in the tocilizumab group and 12 (quartiles 9-15) days in the control group (p=0.014).
CONCLUSION: In hospitalized COVID-19 patients with hypoxemia and elevated inflammation markers, administration of tocilizumab in addition to standard of care was associated with significantly better clinical recovery by day 28 and a shorter hospitalization compared to standard of care alone.