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This study is the first clinical trial in Spain with anakinra, a drug to treat autoinflammatory diseases.
The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the first clinical trial in Spain in which the efficacy and safety of Kineret (anakinra) will be investigated. This drug, to treat autoinflammatory diseases, could reduce the exaggerated inflammatory response and pneumonia in seriously ill Covid-19 patients with “cytokine storm syndrome.” The clinical trial, funded by the biopharmaceutical company Sobi, is an initiative of the Systemic Autoimmune Diseases Group (GEAS) of the Spanish Society of Internal Medicine (SEMI) and will be carried out in ten Spanish hospitals, including the Lozano Blesa University Hospital. from Zaragoza.
The study has set two main objectives: to evaluate the effect of anakinra added to standard treatment, on the need for mechanical ventilation in patients with severe pneumonia caused by covid-19 and cytokine storm; and analyze the effect of the drug on mortality in patients with severe pneumonia caused by covid-19 and cytokine storm.
According to the data collected by the ten hospitals participating in the study, around 20% of all their patients with covid-19 develop this “cytokine storm.” Current clinical observations suggest that, after a first viral phase caused by SARS-CoV-2 infection, in a subgroup of patients the immune system is activated, generating an excessive and uncontrolled immune response (cytokine storm). This response is associated with hyperinflammation and the appearance of acute respiratory distress syndrome or Adult Respiratory Distress Syndrome (ARDS), which has been described as the main cause of mortality from covid-19. In Spain, ARDS – which entails hospitalization and admission to the ICU – has been suffered by 4,8% of the first 18.609 cases with complete information available.
The clinical trial launched after the approval of the AEMPS is led by Dr. Patricia Fanlo, coordinator of the GEAS and the Systemic Autoimmune Diseases Unit of the Navarra Hospital Complex, and will be carried out in 10 Spanish hospitals: the Hospital University Clinic of Santiago, the Son Espases University Hospital of Mallorca, the Navarra Hospital Complex, the La Fe Hospital of Valencia, the Vall d'Hebron Hospital of Barcelona, the Hospital Clínic of Barcelona, the La Paz Hospital of Madrid, the Lorenzo Blesa University Clinic in Zaragoza, the Ramón y Cajal University Hospital in Madrid and the Álvaro Cunqueiro Hospital in Vigo.
The clinical trial will consist of three phases: the first will consist of a selection period, a second two-week treatment period and the third two-week follow-up period. The two-week treatment period is open-label and patients will be randomized to treatment with this IL-1 receptor antagonist added to standard treatment or standard treatment alone in a 1:1 ratio. It will be administered in intravenous infusions four times a day (100 mg/6 hours) for a maximum of 15 days, depending on the patient's health status and the clinical opinion of the experts. The primary endpoint will be evaluated on day 15 and day 28.
