This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab
compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection
and evidence of systemic inflammation.
The aim of this study is to test the effect of Tocilizumab on multi-organ dysfunction in a
phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection.
Specifically, as compared to placebo, we will test whether tocilizumab is associated with a
reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated
inflammatory measures. Multi-organ dysfunction will be measured as the incidence of the
following composite endpoint (mechanical ventilation, renal replacement therapy, mechanical
support, need for inotropes or vasopressors, liver dysfunction (increased bilirubin), and
all-cause mortality). We will also assess multiple pre-specified secondary (exploratory)
endpoints and safety endpoints.
We hypothesize that, as compared to placebo, tocilizumab will reduce transfer to the ICU,
need for mechanical ventilation, increase rates of hospital discharge in patients diagnosed
with severe COVID-19 infection and evidence of exaggerated inflammatory response.