Sponsored by the Papa Giovanni XXIII Hospital, the study is observing responses to siltuximab, a chimeric monoclonal antibody targeting human IL-6 as a treatment for COVID-19 patients who develop serious respiratory complications.
Ergomed is providing clinical development and research services including significant involvement in the study's design and implementation.
Results from the first 21 patients treated with siltuximab and followed for up to 7 days, show seven patients experienced clinical improvement with a reduced need for oxygen support and nine saw their condition stabilise, indicated by no clinically relevant changes.
The next phase of data, which will compare outcomes in matched case-control patients not treated with siltuximab, is expected in the coming weeks.
Dr Miroslav Reljanović, Ergomed’s executive chairman said: "We are pleased to see the preliminary data which will help inform the most appropriate use of siltuximab in patients with COVID-19 suffering from serious respiratory complications.
“We continue to provide clinical development and research services, working closely with the investigators at the Papa Giovanni XXIII Hospital and with EUSA.”
Ergomed added that the study is assessing whether some patients with COVID-19 might respond with overproduction of IL-6, an inflammatory cytokine, leading to a cytokine storm - when the immune system becomes over-stimulated and attacks the patient's own body.
Elevated IL-6 levels are associated with severity of disease and can lead to serious lung complications and/or Acute Respiratory Distress Syndrome (ARDS) - the leading cause of mortality in patients with COVID-19.
Therefore, direct targeting of this cytokine may improve clinical outcomes in these critically ill patients.