Clinical Research Directory

Effect of COV2 Vaccine Formulation on the Ability to Generate Antibodies Against Coronavirus That Causes COVID-19

This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccine formulation randomized trial designed to investigate and compare the safety and immunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein. Participants will receive one of the two COV2 formulations in two doses on Day 0 and Day 28. This trial consists of two parts; Part 1 is a vaccination phase assessing safety and immunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistence of immune response.

Dapagliflozin for Long COVID Syndrome

This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.

Neurological Development In Toddlers After Maternal SARS-CoV-2 Infection During Pregnancy

Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is a virus that causes neurological symptoms in a significant proportion of patients in addition to respiratory symptoms. Intrauterine exposure to the virus has been demonstrated to exert a detrimental effect on the developing nervous system. However, developmental disorders frequently remain undetected until late infancy or early childhood. Consequently, there is a paucity of published data on neurodevelopment in young children following SARS-CoV-2 infection of their pregnant mothers. To this end, detailed data from children aged 36-60 months exposed to SARS-CoV-2 in utero will be compared with unexposed children of the same age on several clinical outcome parameters. Data in this cohort study will be adjusted for possible confounding variables, such as gestational age at birth, sex, or umbilical arterial pH, in order to investigate a relative risk of intrauterine SARS-CoV-2 infection on clinical outcomes, such as child development. Furthermore, the potential protective effect of SARS-CoV-2 vaccination during pregnancy will be investigated. This study will provide significant data on the clinical outcomes of children exposed perinatally to SARS-CoV-2. The findings will enable healthcare providers to establish a risk score-adapted follow-up strategy for the general paediatric population of infants.

mRNA Covid-19 Vaccine Immune Response Comparisons Using Different Delivery Routes

The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using needle and syringe

Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)

The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.

Genome Analysis of Human Endogenous Retroviruses (HERVs)(COVID19)

Human Endogenous Retroviruses (HERVs) are ancient sequences that became integrated into our DNA during evolutionary processes. The significance of their presence in DNA is still being studied, but HERVs appear to be involved in the regulation of the immune response. The gut microbiota is the set of microorganisms that physiologically colonize the gastrointestinal tract. Progressively increasing attention is being paid to the gut microbiota and its potential role in diseases of various kinds. In particular, it has recently been shown how abnormalities in the microbiota can affect immune regulation by determining the occurrence of certain diseases. One objective of the study is to evaluate whether there is an association between the expression of HERVs and clinical manifestations in pediatric age in patients with various diseases such as Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch's Purpura, SARS-CoV-2 infection, or, finally, febrile virosis. Another objective of the study is to evaluate whether there is an association between the presence of particular types of bacteria in the gut microbiota and clinical manifestations in pediatric age in patients with Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch purpura, SARS-CoV-2 infection or febrile virosis. The results from this may open new perspectives for both the care and therapeutic management of children with these diseases.