04/11/2021 16:07
Clarín.com
Society
Updated 04/11/2021 16:07
The biotechnological laboratory Immunova announced this Sunday the publication in a medical journal of
The Lancet
group
of the results of the clinical study of phases 2 and 3
on hyperimmune equine serum
for the treatment of coronavirus and developed by scientists from Conicet.
According to this research, it reduces hospitalization times and the risk of developing severe disease conditions in patients with moderate and mild conditions.
It is the
EClinicalMedicine
edition
, which is part of the prestigious medical publishing house and has a peer review and open access system.
The publication represents an endorsement for this serum developed jointly between public and private scientists, which is not a cure but a
treatment for people already infected
.
The published study details equine polyclonal antibody treatments in patients with moderate to severe Covid-19 disease, and includes an "adaptive, randomized, multicenter, double-blind, placebo-controlled Phase 2/3 clinical trial" conducted in Argentina that, As of its publication, it may be reviewed by the scientific community around the world.
"Anti-SARS-CoV-2 hyperimmune serum (CoviFab®) is a biological drug to treat
moderate to severe
COVID-19
disease
, the development of which was carried out by Immunova based on its experience in protein engineering," the company reported from biotechnology in a statement.
According to Immunova, equine polyclonal antibody immunotherapy enables patients who receive the treatment to
block infectious agents and prevent them from spreading in the body
.
President Alberto Fernández showing the serum team, during a visit to the biotechnology company Inmunova.
Photo EFE.
The published results, meanwhile, reported that "this therapy demonstrated an adequate safety profile in the population evaluated" and that "adverse events of special interest
were mild
and did not require the interruption of the infusion or impede the administration of the second dose. ".
Regarding its efficacy, the study demonstrated
"statistically significant improvement"
in at least 2 categories of the WHO 8-point ordinal clinical evaluation scale at 14 and 21 days;
statistically significant difference in time to improvement in at least 2 WHO ordinal categories or hospital discharge in the group treated with hyperimmune serum versus placebo (14.2 versus 16.3 days, respectively).
It also showed favorable changes in the WHO ordinal scale during the 28 days of follow-up.
This scale establishes categories such as discharge without or with limitation in activities, hospitalization without or with the need for oxygen, mechanical ventilation support, among others.
In addition, the statement reported that the treatment evidenced a favorable trend, although not statistically significant, to the clinical benefit in the most important parameters to measure the progression of patients:
reduction in mortality of 44%
in patients with severe COVID-19, of the hospitalization in intensive care in 29% and the requirement of mechanical ventilation in 33%, compared to placebo.
These results published by The Lancet had already been presented to the National Administration of Medicines, Food and Medical Technology (ANMAT), which on December 22, 2020 authorized the drug for the treatment of adult patients with moderate to severe disease, within 10 days from the onset of symptoms.
Who are behind equine serum
The elaboration of serum from horse antibodies was a work of public-private articulation headed by the Inmunova laboratory and the Argentine Biological Institute (BIOL), the National Administration of Laboratories and Health Institutes "Dr. Carlos G. Malbrán" ( Anlis), with the collaboration of the Leloir Institute Foundation (FIL), Mabxience, Conicet and the National University of San Martín (Unsam).
The project was one of those selected by the National Agency for the Promotion of Research, Technological Development and Innovation in the call "Ideas Project Covid-19" of the Coronavirus Unit, created by the Ministry of Science, Technology and Innovation, and integrated by the Conicet.
Some of the trials were carried out at the Sanatorio Güemes, Hospital General de Agudos "Dr. Ignacio Pirovano";
Italian Hospital of Buenos Aires;
Galician Center of Buenos Aires;
Belgrano Adventist Clinic;
Sacred Heart Sanatorium;
Infectious Hospital "Francisco Muñiz";
Zabala Clinic;
Sanatorio Agote;
Favaloro Foundation;
and Spanish Hospital.
With information from Télam
DD
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