Regulators in the United States have given approval for a Phase III clinical trial of EUSA Pharma’s vaccine for patients suffering from COVID-19 related Acute Respiratory Distress Syndrome (ARDS).
A monoclonal antibody, Siltuximab directly neutralizes interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, including COVID-19. It has the propensity to specifically bind to IL-6, thereby inactivating IL-6 induced signaling.
The double-blind, randomized and placebo-controlled trial is aimed at evaluating the safety and efficacy of intravenous Siltuximab side by side standard care in hospitalised patients with COVID-19 related Acute Respiratory Distress Syndrome (ARDS).
The multi-centre trial aims to enrol around 400 patients with viral ARDS and elevated serum levels of IL-6. The primary objective is to evaluate all-cause mortality at 28 days with the addition of Siltuximab to standard of care, compared to placebo plus standard of care.
Secondary objectives include the following: time to 7-category ordinal scale of clinical status improvement, ventilator-free days within 28 days, organ failure-free days, intensive care unit length of stay, lung function and radiographic improvement.
According to EUSA Pharma’s Chief Executive Lee Morley : “Since the start of the pandemic, a growing body of evidence has been published highlighting that COVID-19 associated ARDS may exhibit features of systemic hyper inflammation, resulting from excessive cytokine production – the so-called ‘cytokine storm’ – with IL-6 recognised as a key driver of this severe condition. Treatment approaches neutralising IL-6 could therefore play a key role in mitigating further detrimental inflammation and progression to respiratory failure, which can be fatal”.
Several independent clinical trials have begun globally to explore the safety and efficacy of Siltuximab for the treatment of severe COVID-19 patients. However, the newly approved clinical trial is very important owing to the fact that these findings require confirmation in a well-controlled and randomised study, though there is limited published data on the safety and efficacy of Siltuximab in COVID-19, EUSA Pharma observed.