COPERNICO, an immunotherapy-based study that aims to investigate an alternative treatment for patients with COVID-19, has reached 29% of the patient recruitment goal to date, with a total of 7 people admitted in two hospitals in Madrid.
As Europe is now in the rise of a second wave of COVID-19, it is our goal to provide this innovative treatment to as many patients as possible. Our goal is to enroll a total of 24 patients within 7 hospitals throughout Spain by the end of 2020. We are also working on adding an additional hospital to participate in Copernico and are hopeful this collaboration will be finalized shortly.
What is the Copernico Study?
COPERNICO is a study with a novel therapeutic approach 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.
Inclusion and exclusion criteria
- 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.
Participating sites of the study
· 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 appreciate the entire investigator team’s involvement in COPERNICO, and we support and encourage everyone in making this a successful clinical trial.