A newly published paper in Lancet Rheumatology presents results from a study assessing the effect of Anakinra, a recombinant IL-1 receptor antagonist, in COVID-19 patients. IL-1 is part of the hyper inflammatory response that characterizes progressing COVID-19 that leads to reduced lung function and death, and so this drug tries to shut down this cytokine.
This is not a randomized study, but an observational study in France including 52 patients given Akinra compared with 44 control patients from the same hospital. Their primary endpoints were time to mechanical ventilation or death. As can be seen below, the results were very promising, with the anakinra group demonstrating much lower rates of ventilation and death.
Of course, the key limitation of this study is that it is an observational study not a randomized clinical trial. It is possible that there are other differences in the patients in the two groups other than just anakinra, and it is also possible that the two groups had other treatment differences. The paper includes a comparisons of the two groups by various measures -- most seem comparable except the control arm had higher mean BMI (29.0 vs. 25.5), fewer given HCQ (61% vs. 90%) or Azithromycin (77% vs. 94%), and they found the anakira effect was still significant after doing covariate adjustment for these and other factors.
Although these results need to be validated in a randomized clinical trial, they are extremely promising, with huge effects of an order of magnitude we have not seen in other COVID-19 studies. The idea of targeting the cytokine storm seems a promising strategy, as this seems to be the crucial event that leads to poor outcomes and risk of death as COVID-19 progresses.
Covid trial explorer shows there are 13 ongoing clinical trials studying anakira, and another 68 that target IL-6, another inflammatory cytokine, using a similar mechanisms, so we should learn more about whether this promising strategy works as these trials mature.