Monoclonal antibodies against Covid-19 have arrived all over Italy. Since the emergency approval of Aifa on 4 February, in each region at least one hospital has started the administration or is taking action to start it up in these days. The first trial was started by the Spallanzani Institute in Rome. Next with the administrations is Liguria, which was the first region to employ them in four centers, last but not least Molise, where the recruiting phase is still in progress.
Covid: monoclonal antibodies if given immediately work
by Letizia Gabaglio
The technique to synthesize this kind of antibodies was developed in 1975 and since then increasingly advanced techniques of genetic engineering have allowed the production of various types of monoclonals, which are currently already used in the diagnostic and therapeutic field. Researchers around the world are trying to synthesize monoclonal antibodies specific for Sars-CoV-2 to prevent the virus, through different mechanisms of action, from spreading in the human body. And at the moment we can count on the drug of Eli Lilly, of which 4,000 doses arrived in Italy in mid-March, and a few days ago on the Regeneron e Roche, the one also used by former US president Donald Trump, of which Aifa has promised 30,000 ampoules shortly. The Ministry of Health has allocated 400 million in the Sostegni decree, guaranteeing a total of just over 150 thousand doses, as soon as they become available.
Pneumonia, the importance of respiratory rehabilitation
By the summer the approval of the first Italian drug: Phase 1 of the clinical trial of anti Covid monoclonals produced by the Monoclonal Antibody Discovery Lab of Toscana Life Sciences Foundation and by mid-May phase 2 and 3 will begin, which will require at least another month, in addition to the emergency authorization times.
Covid: because monoclonal antibodies are needed immediately
by Nicla Panciera
The human monoclonal antibody Mad0004J08 produced on behalf of Tls da Menarini Biotech in the Pomezia plant, and then filled by the Italian Biochemical Institute Giovanni Lorenzini of Aprilia, seems to be the most promising in response to the Sars-CoV-2 infection. Up to now, clinical trials have shown, in vitro and in vivo, that a low dose is enough to obtain a high neutralization power, so much so that it can be administered with aintramuscular injection, decidedly faster and less invasive than current treatments. Also AstraZeneca is engaged in the study of monoclonal antibodies and has developed Azd7442, a long-acting combination that mimics natural antibodies and has the potential to treat and prevent the progression of Covid disease.
Anti-Covid therapies: doubts about monoclonals
by Ernesto Di Cianni
Monoclonals are artificial antibodies. Or rather, synthetic copies of human antibodies that have been shown to be particularly effective in healing the infection. Administration takes place for intravenously, with an hour-long infusion, which must be followed by another observation, preferably within three days of the onset of symptoms and never beyond the tenth. This is because against Covid-19 they have proved effective only if taken early and become useless when pneumonia is now full-blown or the inflammatory cytokine storm has begun.
Covid therapies: variant risk with monoclonal antibodies
by Letizia Gabaglio
Not everyone can access this therapy at the moment. Treatment costs money between 1500 and 2000 euros per person. And to benefit from it at the moment are only people who have risk factors that predict an aggravation that can lead to death. The Italian Medicines Agency has compiled a list of all those who can access this type of treatment: we are talking about elderly people with at least one other pathology or patients over 12 years of age with serious diseases.
The candidates they must not be hospitalized or on oxygen therapy and have a high risk of serious complications that interfere with the immune response. We are talking about obesity, diabetes mellitus, brain and cardiovascular diseases, chronic respiratory diseases, renal failure and immunodeficiency states also due to chemotherapy treatments or transplants.
Covid, tests on monoclonal antibodies produced in Italy are underway
It is the general practitioners, pediatricians and specialists of Uscar in the area who select patients for the use of monoclonal antibodies. Since only non-hospitalized patients can access treatment, only “doctors who have the opportunity to come into contact with patients with recent onset Covid and with mild-moderate symptoms and to refer them quickly to the facility at the hospital can make the selection. which to carry out the treatment “. According to what was written in the Official Journal of February 6, the administration “must take place in compliance with the criteria set by the Technical Scientific Commission of Aifa”, which also required the establishment of “a register dedicated to the appropriate use and monitoring of medicines based on monoclonal antibodies “. In addition, doctors and other health professionals, “as part of their activities, are required to report suspected adverse reactions of the medicines used within and no later than 36 hours”.
Covid, new encouraging data for a “cocktail” of monoclonals
“The monoclonal antibodies produced by Eli Lilly and Regeneron, for which the FDA has issued an authorization for emergency use, are currently the most advanced in clinical development”, explained the Technical Scientific Commission of the Italian Medicines Agency. . “Data from published studies indicate the lack of benefit in hospitalized patients with advanced disease, while use in earlier settings has been associated with a reduction in viral load with preliminary evidence of a reduction in the number of hospitalizations, visits and access to the emergency room “. But while noting the existence of evidence of efficacy, “the data are still preliminary and there is uncertainty as to the extent of the benefit offered”. However, the experts decided that “extraordinarily and in consideration of the emergency situation, it may still be appropriate to offer a therapeutic option to non-hospitalized subjects who, despite having a mild or moderate disease, are at high risk of developing a severe form of Covid-19 resulting in an increased chance of hospitalization and death. In particular, it is a risk setting for which no standard treatment of proven efficacy is currently available “.
In short, it is better to take all the available roads so as not to stand still. “However, we reiterate the absolute need to acquire new scientific evidence that will allow us to more clearly estimate the clinical value of antibodies and define the patient populations that can benefit most from them. In particular, since these drugs cannot currently be considered a standard of care, the Commission believes that both the continuation of ongoing studies and the launch of new clinical studies, including comparative ones, are essential. To this end, it is believed that the independent studies promoted by the Agency with the current announcement could represent a very useful source of further evidence “.
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