After the approval of ANMAT, the study is already carried out in some hospital entities in the City and in the province of Buenos Aires
In the last days, Argentina began trials with serum obtained from horses to treat coronavirus patients with the idea of consolidating it as an effective drug against coronavirus, even beyond when a vaccine is started, experts involved in the project reported in the last hours.
“Our horizon is October, November and December to produce tens of thousands of treatments to meet the needs of the Argentine health system, “said Dr. Fernando Goldbaum, scientific director of Inmunova, one of the laboratories in charge of the trial, for public-private collaboration, in a virtual press conference.
Last week, Argentina approved the research protocol for the clinical study of a hyperimmune equine serum against the new coronavirus, which will evaluate its safety and efficacy in the treatment of SARS-CoV-2 patients.
Specifically, the phase 2/3 trial was authorized – it has already started in a sanatorium in Buenos Aires and will be expanded by around 15 more clinics-, which will be applied in 242 volunteer patients and of which, after having obtained good data in the laboratory, it is expected to be able to have the first clinical results in about two months.
“Using this hyperimmune serum It could be a way to generate a treatment in a fast, safe, effective and simple way to cover this time between the ideal that we all hope for, which is the development of the vaccine, and the use of convalescent plasma, “added Goldbaum.
Greater efficacy than plasma assay
The researcher clarified, regarding the trials of this other project, the use of plasma from patients recovered from COVID-19 to apply in people who continue to have the disease, which “is limited”, since only a very small portion of recovered patients have a high degree of antibodies.
He thus estimated that “the neutralizing power” of the virus by equine serum is “50 to 100 times greater” than the average of convalescent plasma.
Another advantage is that it is not necessary to have donors to generate hyperimmune serum, which favors the larger scale production of the medication.
“Horses have an enormous capacity of produce antibodies“said the doctor, who highlighted the” history of more than 100 years “of the effective use of equine serum for the treatment of diseases.
ANMAT approved this Friday a new investigation for a possible coronavirus treatment
However, when the pandemic broke out, Immunova was already working with him on another treatment for hemolytic uremic syndrome, which redirected the study towards COVID-19.
“We started as soon as the first cases were known, in mid-March, to work, and basically the project consisted of obtaining recombinant proteins, virus antigens. We immunized the first horses and saw that they had a high capacity to respond to the immune system, “said the director of Inmunova, Linus Spatz.
So after detecting that “high amount of antibodies” in animals, its ability to block the coronavirus and prevent it from entering cells was verified.
Application in moderate and severe patients
In the trial with this type of treatment, in which other countries such as Costa Rica are also advancing, the application of the serum is done by two intravenous doses, and the application of each lasts just under an hour.
“One at the time of diagnosis and one 48 hours later. With strict controls to see about adverse effects and allergic reactions that are not expected to be frequent, “emphasized Gustavo Lopardo, infectious medicine doctor and coordinator of the clinical study.
The essay seeks not only to verify the clinical improvement of patients between 18 and 79 years -with a life expectancy greater than one month- in a period of 28 days after receiving the serum treatment, but also that these patients do not need to enter intensive care units or require the use of respiratory support.
It will be carried out, explained the person in charge of Clinical Research at Inmunova, Mariana Colonna, in hospitalized patients who have the virus confirmed by PCR tests and who are in a moderate to severe state, diagnosed with pneumonia.
“It is a model that combines the contribution of the State with that of private technology-based companies,” said the Minister of Science and Technology of the Nation, Roberto Salvarezza.
If the trial confirms the success of the treatment it will be covered initially a first demand for the needs of Argentina, although it is already planned to export to countries in the region that showed their interest.
Equine serum, Argentina’s new hope against coronavirus
A hope even when there is a vaccine
Lopardo stated that this equine serum It was a “really very attractive” challenge, since at the moment there is no approved treatment to face the coronavirus, and he stressed its usefulness even when a vaccine is started.
“Hopefully we have a very safe vaccine, that it does not have adverse effects, and is really very effective in clinical trials and that when it is applied in the population it is very effective. But until now a single disease has been eradicated in the world with vaccine, smallpox, “he stressed.
“But of the dozens of other diseases that are vaccinated, most fail to eradicate the disease. Treatments will continue to have a very important place“he stressed.
Consulted by Efe about the projects that Argentina develops to find a vaccine against COVID-19, Minister Salvarezza pointed out that two are under development: one at the University of San Martín with research from the National Council for Scientific and Technical Research in Argentina and another group from the Universidad del Litoral.
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