Discussion
advents
RECRUITMENT, SECONDARY
This was an open-label, randomized, controlled, multi-center trial comparing anakinra or tocilizumab versus usual care in patients with severe covid-19 at high risk of deterioration. Recruitment of patients was discontinued prematurely when decision, due to emerging data from the REMAP-CAP and RECOVERY trials [Although differences between usual care and the two treatments were not statistically significant for any measure, time to recovery, the primary endpoint, was numerically shorter in the tocilizumab group compared to the usual care arm. Trends favoring tocilizumab were also seen with fewer severe adverse advents and for several secondary endpoints, including fewer days with supplemental oxygen, shorter time to hospital discharge, lower proportion of patients admitted to ICU and receiving mechanical ventilation, and a higher proportion achieving ordinal scale 1–4 by day 15. Improvements in ordinal score also showed tendencies toward better numbers for tocilizumab at day 15, but not at earlier time points. There were limited corresponding positive trends for anakinra.Mortality by 29 and 60 days was similar and unexpectedly low in all three treatment arms, despite inclusion criteria designed to select for higher severity, and despite half of patients being admitted at some point to either ICU or high dependency unit. Baseline severity, as measured by NEWS2, was higher in the usual care group (but only marginally higher as assessed by SOFA and ordinal scores) which complicates assessment. Consequently, improvement in NEWS2 by days 5, 10 and 15 was numerically (but non-significantly) higher in the usual care group.Although some early RCTs using IL-6 blockade failed to show clinical effect [