The HUN and Navarrabiomed publish the findings of the first clinical trial in Spain with anakinra in COVID-19
This randomised study shows that the drug reduces the mean stay of patients in the ICU and produces a radiological improvement in COVID-19-related pneumonia.
This multicentre clinical trial, which was sponsored and led by Navarrabiomed – Fundación Miguel Servet and conducted between April 2020 and October 2021, has allowed the safety and efficacy of the anti-inflammatory and antirheumatic drug anakinra to be evaluated for the treatment of severe cases of COVID-19. The international journal Jama Network Open has published the results, which show that anakinra does not result in significant improvement with respect to conventional treatment in very serious cases as it does not avoid the need for mechanical ventilation or reduce the comparative mortality.
However, use of the drug reduces the mean stay of patients admitted to the ICU and produces a radiological improvement in COVID-19-related pneumonia. Moreover, it appears to be more effective in less severe cases as significant improvements are seen in this group of patients.
The patient sample comprised 179 adults diagnosed with severe COVID-19 and a mean age of 60.5 years. Patients were enrolled at 12 hospitals from seven Autonomous Communities. Thirty six of the 179 patients enrolled in the trial were recruited at the Hospital Universitario de Navarra, with ages ranging from 38 to 81 years. None of these patients suffered any relevant adverse event.
Hospitals involved and funding
The national coordinating investigator for the study was Dr. Patricia Fanlo Mateo, an Internal Medicine consultant at the HUN, who, together with the Clinical Trials team at Navarrabiomed and supported by the Methodology Service, was able to launch and conduct the trial during the pandemic, including seeking the authorisations required and analysing the final results.
The trial was funded by way of COVID-19 projects from the Government of Navarra, which allowed the conduct of studies into coronavirus during the pandemic.
The participating hospitals were: the Complejo Hospitalario Universitario de Santiago, Hospital Álvaro Cunqueiro (Vigo), Hospital Universitario Son Espases (Palma de Mallorca), Hospital Universitario y Politécnico La Fe (Valencia), Hospital Universitario Vall d’Hebron and Hospital Clínic (Barcelona), Hospital Universitario La Paz and Hospital Ramón y Cajal (Madrid), Hospital Clínico Universitario Lozano Blesa and Hospital Miguel Servet (Zaragoza), Hospital Universitario de Cabueñes (Gijón) and the Hospital Universitario de Navarra. The trial was also supported by the Spanish Society for Internal Medicine (SEMI)’s Systemic Autoimmune Diseases Group (GEAS).