01/29/2021 9:54 AM
Clarín.com
Society
Updated 01/29/2021 9:54 AM
The Ministry of Health of the Nation determined this Friday to which patients with coronavirus can be administered equine serum - technically the equine immunoglobulins F (ab ') 2 anti-SARS-CoV-2 fragments - and convalescent plasma.
The key is that the
stage of the disease
must be considered
to indicate these new alternative therapies.
The decision was officially communicated through resolutions 2021-8-APN-SCS # MS and 2021-9-APN-SCS # MS, published in the Official Gazette.
Both resolutions were signed by the Secretary for Health Quality, Arnaldo Medina, after reaching a
technical consensus on
the matter with different scientific societies.
Equine serum
In the case of equine serum, the agreement was with the Argentine Society of Infectology (SADI), the Argentine Society of Intensive Care (SATI) and the Argentine Society of Medicine (SAM).
They are the participating researchers of the clinical trial that determined the effectiveness of use and independent researchers.
The official recommendation indicates that the treatment may be administered "in patients with severe disease with
up to 10 days from the onset of symptoms
, with a confirmed diagnosis of Covid-19", and must "be administered in the hospital setting with medical monitoring in two dose, at a rate of 4 mg / kg of weight with an interval of 48 hours intravenously ".
In the clinical trial carried out in the country, the safety and efficacy were analyzed in a sample of 242 adult patients (18 to 79 years old) 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).
Treatment with equine serum was authorized in the country since the beginning of January and SATI, in the middle of this month, "strongly" rejected the use of hyperimmune equine serum for severe cases of coronavirus.
The medical society did so through a statement and after the harsh pronouncement, the ANMAT and the laboratory in charge of developing the treatment came out to clarify that it was not indicated or approved for these patients.
Now a consensus has been reached.
Convalescent plasma
In the case of plasma from convalescent patients, the consensus involves the Argentine Association of Hemotherapy, Immunohematology and Cell Therapy (AAHITC), the Ibero-American Cooperative Group of Transfusion Medicine (GCIAMT), the Argentine Society of Infectology (SADI), the Consortium of Institutions coordinated by the Italian Hospital of Buenos Aires, the Infant Foundation and the Ministry of Health of the Nation.
These institutions concluded that Covid-19 convalescent plasma should be administered in
patients older than 75 years with less than 72 hours after the onset of symptoms
, who do not present severity criteria and who have a confirmed diagnosis.
Treatment should be carried out according to the criteria of the treating physicians in
consultation with the Transfusion Medicine Service
, and the application will be 1 unit of plasma between 200 and 300 ml, with anti-SARS-CoV-2 IgG titers higher than 1: 1000.
This way of administering plasma, now indicated by Health, is consistent with the results of the study of recovered plasma led by the renowned infectologist Fernando Polack.
Together with his team at the Infant Foundation, months ago he assured that plasma was effective in older adults if it was administered early, within the first 72 hours of the first symptoms.
That study, which lasted 6 months, focused on people over 65 years of age and, on average, most of the participants were over 70 years old.
The Minister of Health, Ginés González García, stressed that these consensuses were reached through work "together with scientific societies to respond to the Covid-19 pandemic with all the resources and tools that we have at our disposal."
Medina, meanwhile, highlighted the fact that these resolutions are backed by the endorsement of the scientists who investigated both therapies: “We reached a consensus with the specialists of scientific societies regarding
the way or the best use we can make
of these great advances, showing the enormous potential of Argentine scientists that positions our country in the elite of nations that base their development on science and technology, "he said.
Look also
"The first evidence of an accessible and safe treatment": what says the paper of the study with plasma of Fernando Polack
Coronavirus: therapists "strongly" rejected the use of equine serum in critically ill patients