During the start of the pandemic, MEDSIR team got together to utilize our expertise in oncology and adapt it to help try and heal the world during this unprecedented time. This resulted in the development of our COPERNICO trial and we are happy to announce that the results have been published in the International Journal of Infectious Disease.
Because severe COVID-19 is associated with immune dysregulation and hyperinflammation (lymphocyte exhaustion and elevated IL-6), we hypothesized that treatment with pembrolizumab, a commonly used immunotherapy cancer treatment, in combination with the immunosuppressant drug tocilizumab might interrupt the hyperinflammation and restore cellular immunocompetence. Therefore, the COPERNICO trial was developed as a randomized, controlled, open-label, phase II trial, to study the safety and efficacy of tocilizumab in combination with pembrolizumab in high-risk hospitalized patients with COVID-19 pneumonia.
"We started this trial at the beginning of the pandemic, when almost no therapeutic options were available for hospitalized patients, and very little was known about this new virus,” remarked Dr. Javier Cortés, Scientific Coordinator of the study and director of IBCC.
The study enrolled twelve patients who were randomized to either treatment with pembrolizumab plus tocilizumab and standard of care (n=7) or the standard of care alone (n=5). The median time to discharge for patients treated with pembrolizumab plus tocilizumab was significantly shorter at 10 days compared 47.5 days for patients treated with the standard of care., There were no COVID-19-related deaths in the experimental treatment group compared to 2 in the standard of care group.
“This therapeutic approach could be a key resource in the management of the most critically ill cases of COVID-19, where sometimes neither dexamethasone, remdesivir, nor other targeted immunomodulators have a significant effect on mortality,” highlighted Dr. Antonio Llombart, PI of the study and Head of Medical Oncology Service at Hospital Arnau de Vilanova (Valencia, Spain).
The study was fully designed, sponsored and self-funded by MEDSIR. We would especially like to thank the patients who participated in the trial and all those who donated to help crowdsource trial, in particular Lucia Be and IEC Trials.