A Spanish company investigates a new treatment for patients hospitalized for coronavirus.
MedSIR, An international clinical research company, created in Spain, and based in Barcelona and New Jersey, has just received authorization from the Spanish Agency for Medicines and Health Products (AEMPS) to carry out the COPÉRNICO study (EudraCT: 2020-002260-28 y NCT04335305), to evaluate the efficacy of a new treatment to improve the prognosis of patients infected with COVID-19, coronavirus.
The COPÉRNICO study will initially be carried out in 6 Spanish hospitals and while it will commence in Spain, the intention is to expand to other countries such as Italy and the United States shortly after. The hypothesis of the study presented by MedSIR is that treatment with a PD-1 inhibitor drug could improve the clinical status of patients with severe SARS-CoV-2 infection. The role of PD-1 has been extensively studied in the field of cancer research.
In this proposed clinical trial, patients infected with COVID-19 who are not responding to standard treatment, will be administered a drug commonly used in the treatment of cancer with the patients’ respiratory aptitude carefully monitored and evaluated. "Knowledge of cancer immunotherapy can help us to exploit these therapeutic strategies, based on enhancing the immune response in patients with serious viral infections. Our working hypothesis is to improve the clinical status of patients with severe COVID-19 infection, impacting on PD-1 activity.” indicates Dr. Antonio Llombart, a lead researcher of this project.
Dr. Javier Cortés, medical oncologist and one of the pioneers of this project, explains: "There is a moment in the process of a viral infection in which the lymphocytes - immune cells responsible for eliminating infection - are exhausted, fatigued and therefore hit the brakes on any activity. The goal of this study is to lock those brakes so that the lymphocytes continue to fight infection.” If the results of the COPÉRNICO study are positive, they could result in a new treatment for symptoms of COVID-19, helping to avoid saturation in intensive care units.
MedSIR was born 8 years ago with the mission of transforming the standard clinical research model. “Today, scientific knowledge is globalized, and talent no longer understands borders, pathologies or competitive watertight compartments. The scientific value of ideas evolves in a transversal way, with a collaborative approach and oriented to the benefit of patients who expect answers. MedSIR is a company dedicated to applying this new model in cancer research, therefore capable of being agile and devising studies that society urgently needs rightnow.” explains María Campos, CEO of the company.
"At MedSIR we are working on innovative projects that can help end the severity of this pandemic," concludes Dr. Cortés.
While MedSIR will assume a major portion of the cost of this trial, additional funding is needed in order to conduct the COPÉRNICO study to its fullest potential, leading the company to launch the following fundraising platform: https://www.medsir.org/covid19-copernico-trial-donation. The first conclusions of this trial could be available in May of 2020.
View at clinicaltrials.gov