Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)
Status:
Terminated
Trial end date:
2020-09-27
Target enrollment:
Participant gender:
Summary
The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has
been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of
influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the
immune system to the virus, causing a cytokine storm with features of Cytokine-Release
Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory
Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of
patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and
low platelets.
There is increasing data that cytokine-targeted biological therapies can improve outcomes in
CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been
approved for the treatment of CRS and is used in patients with MAS. Based on these data, it
is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS
and ARDS.
The overall purpose of this study is to evaluate whether treatment with TCZ reduces the
severity and mortality in patients with COVID-19.