Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC): an open-label, multicentre, randomised, controlled, phase 3 trial
This study in India (n=180) found tocilizumab did not reduce the risk of progression of COVID-19 up to day 14 when compared to standard of care (9% versus 13% respectively; p=0.42) in adults admitted to hospital with moderate to severe COVID-19.
Source:
The Lancet Respiratory Medicine
SPS commentary:
A related Comment discusses the data available on IL-6 blockade as a whole, and the value of this study and another on sarilumab published alongside, which were both conducted in settings outside of the regions where the bulk of the other IL-6 data is emerging. The authors note that treatment and supportive care has been rapidly evolving and thus standards of care in trials that began earlier in the pandemic could be different. For example, concomitant steroid use in this study was low (42%) at the beginning, rising to 70% at 13 weeks. This complicates the interpretation of such negative studies.
The authors of the Comment call for all trial teams to urgently participate in a carefully planned meta-analysis, incorporating analyses for heterogeneous treatment effects and standardised subgroups, and focusing on the important clinical outcome of mortality.