The phase 3 clinical trial to assess siltuximab along with standard of care in hospitalized patients with coronavirus disease linked acute respiratory distress syndrome (ARDS) has been approved by the FDA, stated a global biopharmaceutical company on 02, July, 2020. This new randomized controlled trial will distinguish the clinical efficacy and safety of siltuximab, an interleukin-6 (IL-6) antagonist against placebo along with standard of care. Around 400 hospitalized, COVID-19 patients with ARDS and elevated serum levels of IL-6 will be included. All-cause mortality at day 28 will be regarded as the primary end point.

In April 2014, Siltuximab was approved by FDA for the treatment of minimal Change Disease (MCD) patients that have not been diagnosed with HIV or HHV-8 in April 2014. This year, it has been investigated in trials of severe COVID-19 treatment, for example the SISCO (Siltuximab In Serious COVID-19) study revealed a decreased 30-day mortality rate in patients with serious respiratory issues due to coronavirus.

This study has been planned to be initiated as soon as possible for improved clinical results in COVID-19 critically ill patients, the company’s CEO mentioned.