• 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.