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The Argentine Society of Intensive Therapy (SATI) issued in the last hours a statement in which “strongly recommends not using hyperimmune equine serum (HES) in patients admitted to intensive care, in patients requiring mechanical ventilation and in patients who have received convalescent plasma for COVID-19″.
The warning generated a great debate, especially since after several months of investigation and in the middle of the reappearance of cases of the new coronavirus SARS-CoV-2, the hyperimmune equine serum (CoviFab®) prepared by Argentine scientists had been approved at the end of December by the National Administration of Medicines, Food and Medical Technology (ANMAT) under registration of special conditions for moderate and severe adult patients by COVID-19 and for emergency use. This anti-COVID-19 serum is the first innovative drug for the treatment of infection by the new coronavirus fully developed in Argentina.
As this medium advanced, the conclusions of the clinical trial randomized, controlled and double blind showed that in Phase II / III, this serum reduced morbidity and mortality by almost half (45%) in patients with severe COVID-19. Likewise, the patients treated with INM005 (technical name of the serum) registered a reduction of the hospitalization in intensive care of 24% and the requirement of mechanical ventilation of 36%.
Investigations pointed to a considerable clinical benefit over 28 days of treatment follow-up and significant improvement of two points on the WHO eight-point ordinal clinical assessment scale at 7, 14 and 21 days. This scale establishes parameters such as discharge with or without limitation in activities, hospitalization with or without the need for oxygen, and mechanical respiratory assistance support, among others. The aforementioned positive effects were observed in the population under study, and in particular, in patients with severe disease.
The clinical study evaluated the safety and efficacy of the drug in 242 adult patients (18 to 79 years) with moderate to severe disease caused by SARSCoV-2 infection, confirmed by PCR. The participants were within ten days of the onset of symptoms and required hospitalization. It was carried out in 19 hospitals and clinics in AMBA, Neuquén and Tucumán. The average age was 54 years, with a higher participation of men (65% men and 35% women).
From Registration Under Special Conditions the product is now available for patient application with severe illness by COVID-19 and in pandemic conditions, with the signing of informed consent, expanding the study of its clinical effect through a Efficacy and Safety Monitoring Plan agreed with the ANMAT.
Consulted by Infobae on the criticisms of the Argentine Society of Intensive Care, the Investigator Linus Sparrow, director of Immunova – the laboratory that develops therapeutics – specified: “SATI in its statement recommends not to use something for which it was not even intended. We agree not to use hyperimmune equine serum in intensive therapy because we do not even test it in therapy. Neither the Ministry of Health, nor ANMAT, nor we ask for, express or defend the use of this treatment in Intensive Care Units”.
“We tested the product strictly on moderate and severe patients as stated in the statement and set out the exclusion criteria. In turn, they affirm that it did not give any secondary objective significant. This is not the case, as the primary objective of a trial is always very important. We use as a parameter to measure improvement on day 28, although we already observed significant improvements on day 14 or 21, which were the secondary objectives. The improvement is how many people you gave the treatment are better or worse versus those who were given placebo, “Spatz explained.
As the researcher emphasized that, together with the doctor Fernando Gouldaum, scientific director of Immunova and senior researcher at CONICET, leads the development, “hyperimmune equine serum was never intended for patients in intensive care, we did not do the clinical trial for it and it is not applied in that sector”. “It is applied to people with moderate or severe affection and because it contains fragments of antibodies that block the virus before it enters, therefore the exclusion criterion was moderate or severe people up to 10 days from the date of onset of symptoms, since after this date there are practically no viruses; and generally those who go to intensive care do so after 10 days, at least 80% of them, that is why it was not even thought about and it was never recommended for these cases”.
“The hyperimmune equine serum that we develop is completely safe. We share data with regulatory agencies and the Ministry of Health every month updating the evolution of its use. It is very safe, there were no recorded adverse effects, No medication had to be discontinued in any patient and we already knew this because we worked on Hemolytic Uremic Syndrome (HUS) with the same product in one-year-old boys, with the FDA (US Food and Drug Administration), the EMA (European Medicines Agency) and ANMAT (National Administration of Medicines, Food and Medical Technology, of Argentina) ”, he added.
The SATI document, for its part, although it specifies that the ANMAT authorized by provision 9175/20 the use of hyperimmune equine serum to treat patients with COVID-19, it specifies that, ”Among the main exclusion criteria, were patients requiring mechanical ventilation (MRA) or were admitted to intensive care (IT), and patients who had received treatment with convalescent plasma”.
The text signed by the doctor Queen rose, president of SATI, and doctor Guillermo Chiappero, vice president of the company’s Board of Directors, affirms that, “According to the data presented, the primary and secondary clinical efficacy endpoints were not demonstrated in any case, and no significant differences were found between patients who received HES and those who received placebo, in relation to admission to intensive care, MRA requirement and mortality.”
That is why recommend “strongly not to use hyperimmune equine serum in patients admitted to IT, in patients requiring MRA and in patients who have received convalescent plasma for COVID-19″.
In any case, in the same statement they clarify that, “like any recommendation, is subject to subsequent modifications according to the advancement of knowledge and scientific publications”.
I KEEP READING:
The conclusions of the clinical trial of hyperimmune equine serum approved by the ANMAT
Argentina approved hyperimmune equine serum as a treatment for moderate and severe COVID-19
Coronavirus: the distribution of the hyperimmune equine serum developed by Argentine scientists begins today, which will be visited by the President
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