EUSA Pharma has initiated a study of interleukin (IL)-6 targeted monoclonal antibody siltuximab to treat patients with Covid-19 who have developed serious respiratory complications (Siltuximab In Serious Covid-19; SISCO Study).
Ergomed is providing clinical research services for the SISCO observational case-control study, which is sponsored by the Papa Giovanni XXIII Hospital in Bergamo, Italy.
From a clinical and operational perspective, the company has also been integrally involved in the design and implementation of the study.
Ergomed executive chairman Dr Miroslav Reljanović said: “Covid-19 represents an unprecedented global healthcare challenge and the rapid evaluation of therapies, which could alter the course of the infection and improve outcomes for patients is vital.”
The SISCO study represents the data collection and analysis of a series of patients treated under an ongoing emergency compassionate use protocol.
As part of the study, two cohorts will be investigated retrospectively. Hospitalised patients prior to admission to an intensive care unit (ICU) or patients already requiring intensive care will also be investigated.
The primary endpoints of the study are a reduction in the need of invasive ventilation, time spent in ICU, or 30-day mortality.
EUSA Pharma CEO Lee Morley said: “Following the release of initial data from China suggesting a role of IL-6 in the development of Acute Respiratory Distress Syndrome as a result of Covid-19, EUSA Pharma was pleased to assist Papa Giovanni XXIII Hospital with the supply of siltuximab under compassionate use and to support the collection, analysis and publication of initial outcome data from this series of patients.
“We look forward to working further with the hospital as well as Italian and worldwide regulatory authorities, and other research bodies to fully understand the potential of siltuximab at this critical time in the global pandemic.”
Emerging evidence suggests that exacerbated production of the inflammatory cytokine IL-6 is associated with the severity of the virus related pulmonary pathology associated with Acute Respiratory Distress Syndrome (ARDS).
The latest study will provide important data to inform future clinical studies, with initial data expected late this month.