Waldo Belloso, pharmacologist and infectiologist at the Italian Hospital of Buenos Aires, who coordinates the RUTI study, the first Spanish vaccine to go to the clinic to summon the lucha against the covid-19 pandemic; in this case, to potentiate the effect of the specific vacancies against the SARS-CoV-2.
What is the current epidemiological and sanitary situation in Argentina? Do you have generalized access to any of the vehicles for SARS-CoV-2 (Pfizer-BioNTech, Moderna, …)?
In Argentina we will never be able to freeze the circulation of the virus as suicides after the first oil in many European cities. However, the number of cases in French descent in December has been the first of December and since then there has been a clear increase, fundamentally in spending on the city of Buenos Aires and on the localities of the Province of Buenos Aires, which always have support epidemiologic a little more precedent than the rest of the country. Currently we are clearly in a situation of case escalation, with between 8 and 10 miles of new case files. Fortunately, the health care system is more fortified than the principle of the pandemic, and we are not assisted in the saturation of health care systems at the moment.
Argentina has negotiated with various car manufacturers. Probe ban at the moment the only vacancy available is the Sputnik V rusa. Al país han llegado 300 million doses of the dos dos components of the Sputnik vacuum. An increase in the available doses has been announced since February, but has not yet been determined by the major mayors on placements. Tambien Argentina is a product of AstraZeneca, supuestamente a partir de marzo. The Ministry of Health has prepared a National Plan for Multi-Tactical Vacancy with priority for health workers and the mayor of 60 years with comorbidities, staff essentials related to health, teachers, etc. At the moment en Argentina celebrates 200 million personas’ holiday.
For what reason or motives is the decision to try, in clinical practice, the RUTI as complementary to the specific vacancies for covid-19?
Initially, we are planning the RUTI vaccine drive as a way to get rid of the specific vacancies, as well as any SARS-CoV-2 infection protection or its most serious manifestations. In view of the fact that the initial availability of specific vacancies is accelerated, and that the first line of vacancy priority is superimposed on the objective population of the studio, we decide to complement the strategy with the analysis of the vaccine post for those participating in vacancies specific. It is clear that both vacancies (RUTI and specifics) are subject to different humanitarian mechanisms, and there is a possibility that the previous vacancy with RUTI could potentially impose a humorous and cellular response to the specific vacancy. This is the most attractive studio. We hope that the institutional and regulatory authorities share this vision and provide the authorization for the implementation of the Protocol.
What dimensions and characteristics does the project have (patient profile, sample size, number of centers involved, follow-up, calendar …)?
The RUTICOVID19-ARG studio is an exploratory studio that claims to evaluate this vacancy in 315 volunteers. Currently llevamos 60 participants are included. With the previous mention, the objective publications of the study are as follows: does not specify what you want to do for the next 3 months; yb), persons of the general community with risk of contraindication covid-19 or well to present severely in case of contraerla, between 18 and 59 years of age. Currently, the studio is active in 6 hospitals in Argentina, but we are expecting new centers to be included in the initiative.
What is the purpose of the double bed, included in the official approval of this clinical study?
Any clinical trial in which beneficial clinical and adverse effects are analyzed is facilitated by the use of the double goat because this form can minimize the influence of the staffing staffs of each participant in the final results. In the case of vacancies the expectations and preconceptions are in the order of the day, in a way that there is no alternative but to carry out clinical trials of this manner. It’s one of the best ‘proteger’ forms of dates.
What other studies has been able to realize, and publish, about covid-19?
Our hemos investigated in the convalescence plasma use and the first to publish a double-edged clinical trial in the New England Journal of Medicine. Also hemos investigated in another form of passive immunotherapy, the hyperequin hyperhidrosis, which is a development of an Argentine laboratory, and the study is completed and the manuscript is sent for publication. And as prevention studies, in addition to RUTICOVID19-ARG, we are producing a prophylaxis study pre-exposure to antiretroviral drugs, similar to a studio located in Spain.
From your point of view, how will this pandemic evolve?
The world is what this pandemic is and what we have learned is to recognize the validity of our predictions. The way you are do not believe that the future is written or defined. Clearly the situation is very preoccupying, and the evacuation presents a lot of interrogations and, even in the best of scenarios, its utility as a tangible herring of epidemiological control is not visible in the future. For this, however, depending on how well the media are known to be effective in controlling the diffusion of the pandemic, and how creative are the authorities to understand what their control means are with the mayor’s ability to be accepted and complied with by the people; and there are limits to its tolerance.
A vacancy that lasts 20 years of development
The RUTI vaccine, developed since 2001 for tuberculosis, at the initiative of the team of Pere Joan Cardona, of the Institut de de Investigación Duitsers Trias i Pujol (IGTP) of Badalona, and later by Archivel Farma, with an accumulated inversion of more than 25 million euros.
The laboratory where the authorization is required to carry out its clinical trial in covid-19 in Spain but in Argentina, and now produces in the plant of Badalona, in Barcelona, the lots of vacant lots needed for the study that lidera Belloso.
Archivel Farma was prepared to sum up the active principle of the vaccine for a massive demand in case the results of the positive positive investigation, explained Luis Ruiz, CEO of Immuni Therapeutics, company created by the laboratory, of which is CEO Olga Rué , to unroll RUTI as an agent against covid-19.
Concept of immune system trained
What is the proposal against the SARS-CoV-2? In the concept of immune training trained, which is the primary line of response of the immune system to unknown, pathogenic pathogens and is not antiseptic.
The RUTI, following the view of Pfizer’s BCG, which is the most known and the only one approved for tuberculosis, is currently in its candidacy to complement with its action the specific evacuation effect against the SARS-CoV-2 routers to the generation of antiques, such as the Oxford, developed by AstraZeneca, and the Modern.
There are various clinical trials in the course of averaging if the BCG allows to reduce the impact of covid-19 in individuals with high risk of infection. And here, Ruiz explains, salió the idea of, with the preclinical and clinical data available, llevar also the RUTI to the lucha against the pandemic. It is recommended as a vaccine against tuberculosis, although the BCG, pero, al parecer, has a higher profile of efficacy and security and also generates an estimate of the immune response. It was tested in Africa, in latent tuberculosis, and “well done: it produces specific and safe vaccines”.
Luego, related Ruiz, hubo un paron en su desarrollo, a causa de crisis of 2008 y un cambio de accionistas en Archivel Farma, y se reactivo in 2016, pero como therapeutic agent in tuberculosis resistant.
RUTI is also now in advanced clinical phase in Ukraine and is in the process of initiating clinical trials in India to treat tuberculosis and tuberculosis resistant antibiotics. It is also being tested as a potentiator of the anti-cancer response in patients with cancer..
Tuberculosis cepa
The RUTI, Ruiz explains, is derived from a strain of human tuberculosis under stress conditions (as in the pulmon). “It is cultivated, it is cohesive, it is fragmented, it is filtered and it is lipophilized in the factory of Badalona, which is being prepared for creation. It is a production process and the list for phases 3 and commercial ”.
In Argentina, the Sanitary Administration was very quick to approve an on-site study that is currently being redesigned to evaluate its complementary action mechanism to the specific vacancies against the available SARS-CoV-2. “The context has changed with respect to when we plant the project,” Ruiz recalls.
The laboratory will announce in brief that, through Capital Cell, has leased 1,111,060 euros to finance the Argentine entity and other publications with the immune system alterado.