COPERNICO is a study with a novel therapeutic approach where the aim is to help the immune system of patients infected with SARS-CoV-2 fight the pathogen. The strategy is based on two concepts and two drugs: Tocilizumab and Pembrolizumab (KEYTRUDA®). The first objective is to stabilize the excessive or uncontrolled cytokine storm that contributes to the destruction of healthy tissues, the second step is to stimulate the specific and more targeted immune system response - lymphocytes.
As the spread of COVID-19 continues to accelerate in Spain, the first patient enrolled in August at the Hospital Universitario Ramón y Cajal in Madrid was provided with this innovative treatment.
Up until now we have 2 patients enrolled and our goal is to enroll a total of 24 patients within 7 hospitals in Spain by the end of 2020.
Some inclusion/exclusión criteria are:
~ Patients hospitalized due to acute respiratory syndrome related to COVID-19
~ Low oxygen saturation and low lymphocytes count
~ Modified Sequential Organ Failure Assessment (mSOFA) score ≤ 3
~ Diagnostic confirmation of pneumonia by either chest X-ray or thoracic CT scan
~ Requiring endotracheal intubation, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO) at screening
~ Chronic Obstructive Pulmonary Disease (COPD) or end-stage lung disease that require home oxygen therapy.
~ Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing, except the commonly used antiviral drugs and/or tocilizumab.
The participating sites of the study are:
Hospital Arnau de Vilanova de Valencia
Hospital Universitario Dr. Peset
Hospital Quiron San Camilo- Ruber Juan Bravo
Instituto Oncológico Baselga - Hospital Quiron Salud Barcelona
Hospital Ruber Internacional
Hospital Universitario Arnau de Vilanova de Lleida
Hospital Universitario Ramón y Cajal
We truly appreciate the entire investigator team’s involvement in the COPERNICO study.