The Policlinico Riuniti of Foggia will be the only center in Southern Italy engaged on three different fronts in the battle against Covid.
The reference hub of the Capitanata will in fact be the fulcrum in Puglia to test three different methods of health intervention in preventing the spread of the virus and in testing a new vaccine. At the forefront of the triple work of bulwark to collective health is the complex operating unit of infectious diseases directed by Prof. Teresa Santantonio, committed to carrying out another piece of hope in the studies and evolution of the disease with a important use of professionalism and technological means combined with the pride of having been selected by the main experimentation center (Spallanzani in Rome) for these innovative tests. The professor. Sergio Lo Caputo will be the person in charge of the trials.
VACCINE REITHERA – In March we will start with the ‘phase 2-3’ of the experimentation with the all-Italian vaccine ReiThera to recruit healthy volunteers and then proceed with the administration: a randomized study will be carried out in which 66% of the volunteers will receive the vaccine dose while the rest quota will be treated with ‘placebo’. This data is an excellent opportunity for those who will not be able to access vaccination in a short time (being tested on a healthy population and therefore not at risk) and for health facilities that will have a made in Italy product available immediately available. It will have the same characteristics as the Astra Zeneca, Johnson & Johnson and Russian Sputnik vaccine (the latter will be approved shortly): it will use an adenovirus (all DNA viruses, i.e. containing genetic information necessary for the biosynthesis of RNA – the molecule that transfers genetic information from DNA to proteins – and proteins) with a viral vector. In Puglia the only centers involved will be Foggia and Bisceglie.
The Policlinico Riuniti will then be involved in two trials, both on Covid patients: the first involves the infusion of monoclonal antibodies, the second the use of antivirals. The latter is a still unexplored frontier here in Puglia that makes the Capitanata hospital the forerunner on the genre.
MONOCLONAL ANTIBODIES – In detail, the experimentation with monoclonal antibodies (proteins created in the laboratory that have the same characteristics as those produced by our organism and that bind to a single antigen of the agent you want to fight), recently cleared by the Aifa (Italian Agency of the drug) and spread throughout the territory to collect data and information as heterogeneous as possible on the disease, provides for a study on newly infected Covid positive people but limited to subjects with serious diseases.
The second level of experimentation will be passed in Foggia, also identifying people who do not have serious comorbidities and who can therefore return supplementary data (agreeing or not) with respect to the first group of volunteers. It will start in mid-March even though Aifa has not officially established the modality and timing of the distribution of monoclonal antibodies supplied by the National Health System and then purchased and supplied to the Regions: at the moment there are two types of monoclonal antibodies that Aifa has authorized supporting this type of study because some aspects must be definitively clarified.
Monoclonal antibodies mainly have three different mechanisms of action: neutralizing, piercing the surfaces of pathogens and calling up other cells of the immune system to attack viruses and bacteria. Our antibody neutralizes the virus by binding and blocking the well-known “spike” protein, placed on the surface of the virus and used by the latter to enter and infect the host cells. Once the spike is blocked, the virus is no longer able to infect our body.
“The objective of these studies is to verify that the disease does not evolve – explains Prof. Sergio Lo Caputo – therefore given at an early stage we expect a sharp decline in hospitalizations and in the evolution of the disease. These are intravenous medicines to be administered in hospital in a rather long process, about two hours, which will need a lot of organization from the logistical point of view: we already have in mind how to proceed, which suitable premises will be used for administration. Fortunately, there is still some time to file burrs “.
ANTIVIRAL IN TABLETS – At the same time, also in mid-March, the hospital-university company will be engaged in the third trial of studies relating to Covid-19: this is, as anticipated, an absolute novelty in Puglia. A new antiviral in tablets to be taken for 5 days indicated for people whose tampon has given positive results within a period of up to 3 days. The purpose of the antiviral is similar to the experimentation for monoclonal antibodies, that is to slow down the evolution of the disease and induce a mild form of the virus in the volunteer, inducing paucisymptomatic subjects.
“This confirms – explains Prof. Lo Caputo – what is happening in the Italian infectious diseases departments, that is the great commitment to act on the virus and on the initial stages of the disease before it turns into a pathology more linked to alterations of the immune system. and therefore that it develops the cytochemical storm that causes all the consequences that unfortunately we are well aware of. The important goal is to reduce the amount of symptomatic patients who then go to hospital: this means reducing the workload of all health personnel and allow not to slow down the ordinary activity “.
Volunteers will have to take a tablet on the first day and then will be able to follow the ‘treatment’ at home but return to the hospital if necessary for a more in-depth visit and record the evolution of the therapy. A subsequent step will include a serological control to verify and quantify the level of immunoglobins developed in the meantime. In order to progress in studies and experimentation in this phase, the link with the territory and general practitioners will be very important, whose role will be decisive: from this point of view, SIMIT, the Society of Infectious Diseases of Appulo-Lucan (of which the Lo Caputo himself), is interacting with the Society of General Medicine precisely to collaborate and identify patients to be involved, making use of lists and availability of additional forces to be allocated to awareness and information campaigns for accessions aimed at citizens.
“We have a huge task towards the citizens – underlines the extraordinary commissioner of the Policlinico Riuniti of Foggia Vitangelo Dattoli – that is to study and evaluate every new possible weapon in a complicated and difficult battle that will not abandon us for long. What we will do here at the Riuniti definitely interesting studies and therapy in a scenario in which the availability of the vaccine, which is the only potentially resolving tool of the pandemic, must be sipped and the campaign must be reformulated accordingly. It is clear that we are not talking about resolutive therapies against the coronavirus but we can certainly consider these elements a promising therapeutic option “.
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