Noticias

• Since 2015 the associations annual investment in research has been increased by 65%

On October 27th, 2019 Breast Cancer Association of Navarre SARAY collected 75,000 euros in the solidarity race celebrated in Pamplona. 49,970 euros will fund two studies developed by Navarrabiomed on metastatic breast cancer.

One of the projects is focused on liquid biopsy in this type of cancer, and it is led by Natalia Ramírez Huerto, the head of the Hematological Oncology Unit of Navarrabiomed. SARAY´s contribution for the second year of the project development raises to 24,970 euros. Other study lead by Cancer Signaling Unit head Imanol Arozarena Martinicorena will receive 22,000 euros. His project aims to develop new adjuvant therapies to treat brain and bone metastases from these tumors. The additional funds will be donated to the Chronos Hope Project from Solti Foundation.

On the 25th of June SARAY decided to allocate the incomes in a face-to-face and online assembly among 725 associates (event delayed three months later due to the COVID-19 crisis). During the last years, the organization shows a strong commitment with biomedical research performed in Navarre. Therefore, it is relevant to highlight that since 2015 SARAY has increased by 65% its annual investment in oncology research.

• Navarrabiomed se ha inscrito ya junto a universidades, centros tecnológicos y de investigación
   

Diez entidades se han inscrito ya como agentes de ejecución del Sistema Navarro de I+D+i (SINAI), que incluye a universidades, centros tecnológicos y centros de investigación, entre otros.

En concreto, se han acreditado la Universidad Pública de Navarra, la Universidad de Navarra, Navarrabiomed, el centro tecnológico Lurederra, el Centro Nacional de Energías Renovables (CENER), el Centro Nacional de Tecnología y Seguridad Alimentaria (CNTA), la Asociación de la Industria de Navarra (AIN), y ADItech, que actúa como coordinador.

También se ha acreditado la Asociación de Daño Cerebral Adquirido (ADACEN) como entidad singular, figura de nueva creación orientada a las actividades de difusión y divulgación de ciencia, y otras actividades de apoyo a la I+D. Asimismo, se ha inscrito el Centro Stirling como unidad de I+D+i empresarial, otra nueva figura con la que el Gobierno de Navarra permite que el SINAI acoja a las empresas como agentes de ejecución del sistema.

Además, cabe destacar que en los próximos días se completará la acreditación de los centros IdiSNA, Naitec y CIMA.

Por otro lado,  ya está  a disposición de estas entidades el sello que les identificará como agentes acreditados, y que podrán incorporar en sus respectivos logotipos en las próximas semanas.

Beneficios y requisitos de los agentes de ejecución

El objetivo del Sistema Navarro de I+D+i (SINAI) es dotar al sistema innovador navarro de una buena coordinación y orientarlo hacia la excelencia. El registro público que acredita a los agentes de ejecución integrados en él les permite que puedan disfrutar de condiciones preferentes para desarrollar I+D+i.

De esta forma, se genera un sistema de innovación que elimina barreras entre innovación académica y empresarial, fomenta la optimización de infraestructuras, eleva el nivel de los centros tecnológicos y de investigación, y asegura una I+D inclusiva con las mujeres, y un número mínimo de doctores y doctoras. El objetivo final es que grandes compañías puedan financiar su propio instituto de investigación o entidad de I+D.

El proceso de acreditación como agente de ejecución del SINAI es vivo y abierto, por lo que pueden seguir inscribiéndose los centros que lo deseen y cumplan los requisitos.

Así, pueden obtener esta calificación las universidades,  centros de investigación, institutos de investigación sanitaria, centros tecnológicos, unidades de I+D+i empresarial, entidades singulares y coordinadores de agentes de ejecución.

Quienes se registren como agentes podrán participar en programas y convocatorias de ayudas específicas a las que anteriormente no tenían acceso, hacer uso de las infraestructuras de investigación de todos los agentes del sistema en condiciones preferentes, y participar en los programas de atracción de talento internacional gestionados por la Administración de la Comunidad Foral.

Para beneficiarse de estas ventajas, las universidades, centros de investigación, institutos de investigación sanitaria y centros tecnológicos que quieran registrarse en el SINAI deberán contar con personal investigador doctorado en plantilla (con una presencia equilibrada de mujeres y hombres), y participar en proyectos de I+D+i, también de ámbito internacional.

Las unidades de I+D+i empresarial, con las que se busca potenciar la innovación dentro del sector privado, también deberán contar con personal investigador doctorado en plantilla, y tendrán que promover el uso de la tecnología e innovación por parte de las empresas titulares. Las empresas matrices de las unidades de I+D+i podrán deducir el 50% de los gastos correspondientes a proyectos de I+D contratados con dichas unidades acreditadas como agentes de ejecución del SINAI.

Además, para obtener la acreditación como entidad, las entidades solicitantes deberán realizar actividades de difusión y divulgación de ciencia, y otras actividades de apoyo a la I+D.

Por último, cabe indicar que la figura de coordinador, además de organizar al  resto, y dinamizar la relación entre ciencia, tecnología y empresa en Navarra. Actuará también como interlocutor de los agentes del SINAI ante la Administración Foral, organizará el proceso de evaluación, y contribuirá a la mejora de la excelencia de los agentes del Sistema Navarro de I+D+i.

Saioa Mendaza Lainez, investigadora predoctoral en la Unidad de Patología Molecular del Cáncer de Navarrabiomed, realizará la lectura de su tesis doctoral por la Universidad Pública de Navarra el martes 30 de junio, a las 11:30, a través de videoconferencia en Navarrabiomed (solamente podrán acudir aquellas personas autorizadas previamente). 

La tesis, titulada Approaching the epigenome of triple-negative breast cancer to identify new biomarkers, ha sido desarrollada en Navarrabiomed bajo la dirección del Dr. David Guerrero Setas y la Dra. Esperanza Martín Sánchez.

El cáncer de mama es la neoplasia más frecuente en mujeres a nivel mundial y la primera causa de muerte por cáncer en este mismo sexo. La investigación aborda el cáncer de mama triple negativo (CMTN), un subtipo que a diferencia del resto carece de tratamiento dirigido, lo que conlleva consecuencias más agresivas en las personas que lo padecen. Esto hace que a día de hoy, la búsqueda de nuevos biomarcadores y dianas terapéuticas para esta enfermedad sea imprescindible.

Dado que las alteraciones epigenéticas están involucradas en la tumorigénesis, el objetivo de esta tesis ha sido caracterizar la metilación del DNA y la acetilación de histonas de este tipo de cáncer. Con ello se ha buscado identificar nuevas firmas potencialmente diagnósticas y pronósticas, así como alteraciones destinatarias de fármacos dirigidos.

Los resultados de esta caracterización han permitido concluir que el patrón epigenético está alterado en CMTN respecto a tejido mamario no neoplásico. Más importante aún, la investigación ha desvelado dos alteraciones epigenéticas específicas como potenciales biomarcadores de peor pronóstico: la acetilación de la histona H4K5 y la hipometilación del gen ADAM12, el cual se presenta también como posible diana terapéutica frente a este cáncer.

Asimismo, se ha identificado una nueva firma basada en metilación de DNA con utilidad diagnóstica. Por último, se han descrito los procesos biológicos de los distintos genes regulados por la acetilación de H4K6 en líneas celulares no neoplásicas y CMTN.

El trabajo realizado ha dado lugar a tres publicaciones científicas y ha sido difundido en dos congresos consecutivos de European Association for Cancer Research; uno celebrado en Manchester en el año 2017 y en Amsterdam en el 2018.

Para el desarrollo de la tesis Saioa Mendaza ha sido beneficiaria de dos becas: Ayudas para la formación de Personal Investigador de la Univesidad Pública de Navarra  para la realización de tesis doctorales y Beca a la excelencia de la Funcación Caja Navarra para la realización de una estancia en University of Massachussets Medical School (EEUU).

• The Government of Navarre provided €1.1 million in funding for eight research projects and has now added two more Navarre initiatives to the list of recipients of funding from the Carlos III Health Institute

María Chivite, the President of the Government of Navarre, recognized “the good work” being done at research centers and institutes in the Region of Navarre to find alternatives that help alleviate the effects of COVID-19. She spoke in the context of a meeting she attended this morning with ten researchers in charge of their own publicly funded studies on this disease, which has caused 515 deaths in Navarre and more than 27,000 in all of Spain.

The meeting was also attended by Santos Induráin, the Minister of Health, and Juan Cruz Cigudosa, the Minister of University, Innovation and Digital Transformation, and provided a firsthand opportunity to learn about the research purpose of the projects that have received grants from the Navarre COVI+D Fund. Created by the Government of Navarre to promote research on this topic, the fund paid out €1.1 million in May to eight projects that had received a favorable assessment from the Carlos III Health Institute. The Carlos III Health Institute has also provided direct funding of €232,000 for two other Navarre research projects.

Chivite took advantage of the forum to remind the participants of the Government of Navarre’s commitment to innovation and research “as a model of economic and social development,” not just through these grants, but also by means of the R&D&i Emergency Plan, presented last week, and the Reactivate Navarre Plan / Nafarroa Suspertu 2020-2023. The Government is also committed to improving technological infrastructure and promoting supra-regional cooperation. “We want Navarre to lead the way in biomedicine because we have the talent and skills to do just that. It’s one of the strategic areas we’re working on. We have to be able to transfer knowledge and research to favor industrial and technological development,” she said, before expressing her confidence that Navarre will become “a key stop on the R&D&i map.”

Chivite confirmed that the goal of the Government of Navarre is “to keep increasing investment and setting up strong pillars for the model of growth.” Navarre will thus be prepared for future challenges of the likes of COVID-19.

Chivite informed the researchers of the public support of their research work, though “people are aware of the pressure you’re under when you’re studying this coronavirus, because of the high expectations about finding a vaccine, treatments and other aspects that could alleviate the effects of a virus that has had a major impact on our society.” She asked for respect “for the time frames, rigor and meticulousness” of the researcher’s work, and also expressed hope that this work would promote “true and instructive information” that avoids fake news and disinformation in society as a whole.
 

Ten projects

In addition to President Chivite, the meeting was attended by Rosario Martínez, the Director General for Innovation. Also attending were the researchers from the ten projects that received public funding: Luis Martínez de Morentin, Fermín Mallor Giménez, Borja Sáez Ochoa, Natalia Ramírez Huerto, Jacinto López Sagaseta, Pablo Sarobe Ugarriza, Patricia Fanlo Mateo, David Escors Murugarren, Jesús Castilla Catalán and Leyre Ruete Ibarrola, who attended in representation of Beatriz Lacruz Escalada. They were joined by the heads of the different research centers where the projects are being carried out. This group included María Rosario Luquin, the Scientific Director of  the Navarre Health Research Institute (IdiSNA), Claudio Fernández, the Director of the Lurederra Foundation, and Íñigo Lasa Uzcudun, the Director of Navarrabiomed.

The directors of the ten research projects presented their lines of research, which include the study of possible vaccines, the use of specific drugs, resource management, the development of preventive measures and products, and the analysis of incidence bearing in mind sociodemographic characteristics and other conditioning factors.

The Government of Navarre aims to promote Navarre innovation and national prominence through the COVI+D Fund grants. But the goal is also to attract scientific talent, given the fact that these grants include staff payroll expenses.

• After working exclusively on COVID-19 disease control in recent months, the professionals at the SNS-O went back to work on the EGALURG Project with an online meeting organized by Navarrabiomed

On 3 June 2020, Navarre organized the first videoconference meeting of the cross-border cooperation network EGALURG, whose aim is to guarantee access to health care in emergency and catastrophic situations in the regions on both sides of the Pyrenees in France, Andorra and Spain and on equal terms.

The professionals at the Navarre Health System-Osasunbidea (SNS-O) will work in coordination with experts from the regions of Occitanie, Nouvelle-Aquitaine and Catalonia. The Navarrabiomed research center, a member of the EGALURG network, facilitated the connection between these professionals.

The EGALURG network is led by Toulouse University Hospital and its partners include Bayonne Hospital and Emergency Medical Services of Catalonia, in addition to Navarrabiomed. The network is being developed within the framework of European Interreg Program V-A Spain-France-Andorra (POCTEFA 2014-2020). It officially started its activity in November 2019 and has a duration of 30 months. To date, two partner meetings have been organized: the first, on 19 December in Toulouse, and the second, the one held yesterday as a videoconference in compliance with the national de-escalation plan.

The EGALURG consortium will work on improving health care throughout the Pyrenees to prevent the border from becoming a legal and administrative hurdle, and to promote interregional cooperation in health care. The initiative also focuses on the coverage provided to geographically isolated towns and people in emergency and catastrophic situations.

To achieve such an improvement in health care, EGALURG will work in the coming months on harmonizing protocols for patient care in order to anticipate and manage the medical equipment required. It will also develop innovative tools for increasing efficiency in health care by preventing different systems and languages from becoming an obstacle. Records will be kept in each region and a common IT platform for assessment and research will be set up based on epidemiological data.

EGALURG in Navarre

The Navarre work group will develop and implement a database on characteristics of severe injuries and an operating inventory of common cross-border resources. It will also coordinate the network’s communication activities by developing different activities and coordinating all the agents in the regions involved.

Given the current situation caused by COVID-19 disease, EGALURG has postponed a number of face-to-face events and training sessions, which will prepare for and guarantee excellent collaboration between professionals. The team trusts that by next year it will be possible to organize simulation events and stays. “Simulation is key because it enables health care personnel to train in locations with a context like the ones found in emergency and catastrophic situations. We hope to be able to reschedule the activities planned and, by 2021, hold meetings to share protocols and good practices”, said Arantxa Ibarrola Segura, the manager of the project in Navarre.

The total budget to carry out EGALURG comes to €2,343,192, of which €1,523,075 (65%) have been co-funded by the European Regional Development Fund (ERDF) through Interreg Program V-A Spain-France-Andorra (POCTEFA 2014-2020). The goal of the POCTEFA program is to strengthen the economic and social integration of the Spain-France-Andorra cross-border area. Its help is focused on developing cross-border economic, social and environmental projects through joint strategies in favor of sustainable regional development.

•    A consortium made of more than 600 professionals from 50 countries highlights the importance of confirming the diagnosis of people presenting with alterations in their capacity to smell and taste
 

Navarrabiomed is participating in an international research project that has confirmed that most people suffering from COVID-19 experience a loss of their sense of smell and/or taste. This initiative is part of an international consortium made up of more than 600 professionals from 50 countries.

Enrique Santamaría Martínez PhD, Head of the Navarrabiomed Clinical Neuroproteomics Unit, is responsible for leading the center’s participation in an international consortium that has confirmed the direct relationship between COVID-19 and anosmia (loss of the sense of smell) and the reduction in taste capacity in early stages of the disease. More than 600 professionals from 50 countries are collaborating on this study, whose findings may determine who is given diagnostic tests in new outbreaks.

On 7 April 2020, the Global Consortium for Chemosensory Research (GCCR) launched a massive survey with the aim of gathering sensory information on the ability to smell and taste of participants, people diagnosed with an objective test such as PCR or after clinical assessment no more than 15 days prior to responding to the survey. Among other variables, participants were asked to quantify their smell, taste and chemesthesis function (their capacity to smell, taste and perceive cooling, tingling and burning sensations in the mouth) before and while suffering from COVID-19 disease. They were also asked to mention any kind of nasal obstruction that had occurred.

The consortium obtained preliminary results 11 days later, on 18 April, and published the findings on 8 May in the free-access repository medrxiv.org. A total of 4,039 people from more than 40 countries filled out the survey and an analysis of the results indicates that smell, taste and chemesthesis were significantly reduced in patients diagnosed with COVID-19 disease. It is important to point out that nasal obstruction does not seem to be associated with these losses, which suggests that it may be an indicator for differentiating infection from SARS-CoV-2 from other viral infections such as cold and flu (which do produce nasal obstruction).

The reduction in the capacity to smell and taste may be taken as a distinctive characteristic of possible cases of COVID-19 arriving at hospitals and health centers and that require confirmation by means of a diagnostic test.

The project is different from previous studies on chemosensory abilities and COVID-19 because it proposes a massive international approach within a collaborative open-science framework. The study is led by Valentina Parma (Temple University, Philadephia, USA), John Hayes (Penn State, USA), Thomas Hummel (Technische Universität Dresden, Alemania), Steve Munger (Universidad de Florida, USA) and Danielle Reed (Monell Chemical Senses Center, USA). 

Research in progress

The consortium has now received more than 37,000 responses and the survey is still active. Navarrabiomed encourages anyone who has recently suffered from a respiratory disease, including COVID-19, to go online to https://gcchemosensr.org/ and fill out the survey in one of the 29 languages available. “Patient participation is key for determining the symptomatology of SARS-CoV-2. Consortium committees are currently organizing specific research projects that will make use of all the information compiled in the GCCR initiative,” said Dr. Santamaría.

The Navarrabiomed Clinical Neuroproteomics Unit is interested in determining why COVID-19 patients lose their sense of smell. To answer this question, the Unit is collaborating with the group of Dr. David Escors (Head of the Oncoimmunology Unit, Navarrabiomed) in order to untangle the molecular mechanisms that are altered at the olfactory level by the SARS-CoV-2 virus.

“One of the coronavirus’s access routes is through the nasal cavity, which is why analysis of the “nose-brain” route could provide information on why strokes, seizures and encephalitis have been observed in some COVID-19 patients”.

Furthermore, according to preliminary results from the seroprevalence study carried out by the Spanish Ministry of Health and the Carlos III Health Institute, the loss of smell should not merely be considered an early symptom of COVID-19 disease, but also a predictor of immune response,” Dr. Santamaría said.

The Navarrabiomed Neuroproteomics Unit, in collaboration with public and private health institutions in Navarre, is currently working on the development and deployment of precision olfactory medicine, which, together with immunological analysis, will lead to more effective diagnosing and monitoring of the many diseases involving loss of smell, one of which is COVID-19.
 

• 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.

• The Carlos III Health Institute finances two projects in Navarre through Spain's COVID-19 Fund and grants the full amount applied for in both cases. 

The Spanish Ministry of Science and Innovation, through the Carlos III Health Institute (ISCIII), has awarded €232,000 to develop two public research projects within the context of the Navarre Health Research Institute (IdiSNA). David Escors Murugarren, a researcher at Navarrabiomed, and Jesús Castilla Catalán, a researcher at the Institute of Public and Occupational Health of Navarre (ISPLN), have received 100% of the amounts they applied for from the COVID-19 Fund, a mechanism approved by Royal Decree-Law 8 of 17 March 2020 on urgent extraordinary measures for dealing with the economic and social impact of COVID-19.

David Escors, the principal investigator at the Navarrabiomed Oncoimmunology Research Unit, began his scientific career working on coronaviruses at the Spanish National Biotechnology Center (CNB-CSIC), along with researcher Luis Enjuanes. He then continued his work at University College London (UCL) by applying lentiviral vectors and gene therapy in immunotherapy. He is a coronavirus specialist and the positive evaluation received from the ISCIII will enable him to obtain the €115,000 he applied for to develop the project “Platforms for developing biosafe SARS-CoV-2 vaccines.”

The aim of the initiative is to develop a platform for engineering biosafe vaccines for the virus that causes COVID-19 disease. The focus will be on the expression of viral proteins that may activate immunity. This line of research was started up specifically for COVID-19, given the current health emergency, but is based on the European ISOLDA Project - Horizon 2020 for generating more effective and safer virus vaccines (yellow fever, influenza and coronavirus) for adults over 65. Navarrabiomed has worked on this project since 2019 in coordination with professionals from the Spanish National Research Council (CSIC) and with Dutch, German and Italian collaborators.

Institute of Public and Occupational Health of Navarre

At the Institute of Public and Occupational Health of Navarre’s Group of Infectious Diseases and Vaccines, Jesús Castilla will lead the study “Infection, Hospitalization, ICU Admissions and Deaths Caused by SARS-CoV-2 in a Population Cohort.” To carry out the study, he will also receive the total amount applied for from the ISCIII: €117,000.

His proposal focuses on estimating the effect of sociodemographic characteristics, chronic diseases and other conditioning health factors on the risk of infection, hospitalization and severe forms of COVID-19. This will involve calculating the incidence of suspected cases, infections confirmed using PCR, hospitalizations, ICU admissions, assisted ventilation and mortality. The mortality rate will also be calculated in confirmed cases and hospitalizations. Antibody seroprevalence will also be evaluated in a sample of patients from the sentinel physician network and/or donors.

This is the second SARS-CoV-2 initiative for Jesús Castilla, given the ISPLN’s participation in the European project I-MOVE-COVID-19, with the involvement of 11 countries and 20 organizations. It is one of the European projects funded through the fast-track call of Horizon 2020, the European Union’s research and innovation program to promote research of different aspects of the SARS-CoV-2 virus.

Both research projects financed by the ISCIII will form part of the scientific activity of the IdiSNA, a public-private partnership for promoting biomedical research in Navarre. Both the ISPLN and Navarrabiomed are partnership members.

• The Navarrabiomed Clinical Trials Platform will manage the participation of the Navarra Health System-Osasunbidea (SNS-O) in seven more clinical trials

The Hospital Complex of Navarre (HCN) will participate in the COVID Human Genetic Effort international initiative (COVIDHGE), whose mission is to identify human genetic variants underlying severe forms of COVID-19 produced by the SARS-Cov2 virus in young, previously healthy individuals. This participation has been arranged by the Navarrabiomed Clinical Trials Platform, which will manage the SNS-O’s performance of seven additional clinical trials.

CHN pediatrician and pediatric neurologist Sergio Aguilera will lead the COVIDHGE study in the Navarra Health System. The CHN’s Pediatrics, Internal Medicine and Intensive Medicine services will also participate. They will be coordinated by three professionals: Mercedes Herranz (Pediatric Infectious Diseases), Iñigo Les (Internal Medicine) and Manuel García-Montesinos (ICU).

In addition to the SNS-O, reference centers in countries throughout the world are participating under the leadership of researcher Jean-Laurent Casanova of the Rockefeller University in New York and Necker Hospital in Paris. In Spain, the study is being coordinated at the national level by Vall d’Hebron Hospital and the Bellvitge Biomedical Research Institute (IDIBELL).

Patient profile

The CHN team will recruit patients with COVID-19 under 60 years of age without comorbidities (coexistence of two or more diseases) in different groups. The largest group will include young people with no chronic diseases who were admitted to the ICU. A second group will be made up of previously healthy patients under 60 who required hospitalization, but not admission to the ICU, and a third group will include subjects with mild or asymptomatic cases of COVID-19, especially people who were exposed to the virus, but have not developed symptoms or produced antibodies. Consideration will be given to creating an additional subgroup that includes adult and pediatric patients with neurological complications within the context of COVID-19.

The project has been approved by the Ethics Committee for Drug Research of the Region of Navarre and will involve taking a single blood sample from subjects. The sample will then be sent to the IDIBELL genomics lab, directed by Dr. Aurora Pujol, a professor at the Catalan Institution for Research and Advanced Studies (ICREA). The IDIBELL genomics lab will perform and analyze whole-exome and -transcriptome sequencing. The data will be shared with and studied by the COVIDHGE international consortium. The aim of whole-exome sequencing in both patients with severe COVID-19 and controls (subjects with mild or asymptomatic cases) is to identify the human genetic variants that cause the most severe cases, as well as protective variants.

The Navarrabiomed Clinical Trials Platform has provided advice and support for early project startup in Navarre. Platform heads Ruth García and Eva Zalba (Heads of the Clinical Area and Management Area, respectively) consider “this kind of international collaboration to be essential for the development of new preventive and diagnostic strategies in the future.”

Other clinical trials

In addition to this study, a few weeks ago, Navarrabiomed arranged for the CHN Pharmacy Service to join a national study to set up a register of COVID-19 treatments, and for CHN to form part of a clinical trial led by the Spanish Ministry of Health’s National AIDS Plan to assess the drugs used in AIDS treatment, which could prove effective against COVID-19 disease.

The Clinical Trials Platform is currently processing three more clinical trials to assess the efficacy of different drugs against SARS-CoV-2. Definitive approval from the Spanish Agency for Medicines and Medical Devices (AEMPS) is expected in the next few days, as are favorable reports from the Ethics Committees so that these trials can start as soon as possible.

This week, Navarre will also join a national multicenter clinical trial for the production of hyperimmune plasma from COVID-19 convalescent donors that is subjected to pathogen reduction technologies, with the participation of the Navarre Blood Bank and the CHN Internal Medicine and Hematology Services. The Pediatrics and Gynecology Services will also join a clinical trial to analyze the impact on pregnant women and newborns to learn more about infection transmission and the immune response.

• 21 European institutions join forces to tackle end-stage liver disease and liver failure with a systems medicine approach
• Navarrabiomed-FMS takes part in the project through the Traslational Bioinformatics Unit.
   

Despite a vast array of available interventions and medications, more than 1 million people die of chronic liver disease (cirrhosis) per year worldwide, when the disease progresses to decompensated cirrhosis and acute-on-chronic liver failure (ACLF), a state in which the dysfunctional liver induces failure of other organs.

Following an acute decompensation of cirrhosis, 14% of the patients die of ACLF within 3 months. The reason why certain patients die and others survive is unknown, but huge differences between patients with regard to their individual genetics, medical history, precipitating events, clinical presentation and treatment response are suspected.

These individual differences call for personalised treatments based on a precise understanding of underlying mechanisms. Systems medicine and high-throughput technology nowadays allow for highly efficient analysis, integration, and predictive modelling of clinical data to develop the best fitted, most personalised treatment for each patient.

Over the next 5.5 years, the DECISION research consortium will analyse and integrate data from already existing clinical data and biological samples from 2,200 patients with cirrhosis at more than 8,600 time points to identify novel combinatorial therapies, validate them in animal models, and then test the most promising combinatorial therapy in a clinical trial.

The overall aim of the DECISION project is to prevent ACLF and to significantly reduce the mortality rate amongst patients with decompensated cirrhosis. The project receives 6 million € funding from the European Commission.
 

• Website: decision-for-liver.eu/
• David Gómez Cabrero. Head of the Traslational Bioinformatics Unit.