• Ten hospital centers in seven autonomous communities are participating in the research study

The Hospital Complex of Navarre (CHN) and Navarrabiomed will lead the only clinical trial with anakinra authorized in Spain, the aim of which is to assess the efficacy and safety of this anti-inflammatory and anti-rheumatic drug in patients with severe cases of COVID-19 at a total of 10 hospital centers in seven autonomous communities.

The trial specifically aims to assess the efficacy and safety of anakinra in a sample of 180 patients with the aim of reducing inflammatory response and severe pneumonia triggered by so-called cytokine storm syndrome caused by SARS-CoV-2. According to data from participating hospitals, around 20% of COVID-19 patients develop the syndrome.

The research study is supported by the Group of Systemic Autoimmune Diseases (GEAS) of the Spanish Society of Internal Medicine (SEMI). Italy is the only other European country where a similar study has been authorized.

The research study is coordinated by Patricia Fanlo, a CHN specialist in internal medicine, and the Navarrabiomed Clinical Trials Platform. Fanlo is optimistic about administration of the treatment: “We’re working on the hypothesis that the main cytokine that must be inhibited in cytokine storm syndrome caused by SARS-CoV-2 is interleukin (IL-1). In a preliminary study on a small sample of CHN patients, we saw that patient symptoms became less severe 48 to 72 hours after administration of anakinra,” she said.

Treatment with anakinra helps block IL-1, a pro-inflammatory cytokine that is released in infectious and inflammatory processes. Anakinra is administered regularly in the treatment of rheumatoid arthritis and anti-inflammatory disorders such as familial Mediterranean fever and TNF receptor associated periodic syndrome (TRAPS). Blocking IL-1 could inhibit the inflammation caused in this case by the excessive immune response of some COVID-19 patients and prevent them from developing more severe symptoms requiring mechanical ventilation or intensive care.

The clinical trial will also provide complementary data such as the decrease in viral load, mortality rate at 28 days after drug administration, time spent in the ICU, time spent in the hospital, and time until discharge from the hospital.

Centers involved and funding

The Navarrabiomed Clinical Trials Platform has obtained authorization from the Spanish Agency for Medicines and Medical Devices (AEMPS) and the Ethics Committee to carry out the clinical trial at nine hospital centers, in addition to the CHN, by highly qualified researchers in the field of internal medicine, all of whom are members of the SEMI’s GEAS. The following centers are participating in the clinical trial: the University Hospital Complex in Santiago, Álvaro Cunqueiro Hospital in Vigo, Son Espases University Hospital in Palma de Mallorca, La Fe Polytechnic University Hospital in Valencia, Vall d’Hebron University Hospital and the Clinical Hospital in Barcelona, La Paz University Hospital and Ramón y Cajal Hospital in Madrid, Lozano Blesa University Clinical Hospital in Zaragoza and the Hospital Complex of Navarre.

The biopharmaceutical company Sobi has agreed to collaborate with the project by supplying the drugs required free of charge so the clinical trial can begin and to provide incentives for research of the SARS-CoV-2 virus in Spain. The directors of the clinical trial also applied for one of the grants for COVID-19 projects recently approved by the Regional Government of Navarre’s Ministry of Universities, Innovation and Digital Transformation.

To date, Navarrabiomed has managed implementation of 11 COVID-19 clinical trials in the Navarre Health Service - Osasunbidea. Clinical Trials Platform heads Eva Zalba Garayoa and Ruth García Rey said, “The collaboration between health professionals and support services for clinical research is vital to be able to start research projects as soon as possible to find new therapeutic options that help keep patients from advancing to more severe phases of the disease.” The World Health Organization (WHO) has ranked Spain in fourth place in the world and first in Europe in the number of clinical trials carried out on the coronavirus.