- Equine antibodies in clinical trial without any severe adverse effect.
Researchers from the Costa Rican Social Security Fund (CCSS) and the University of Costa Rica (UCR) analyze the results of the study of equine antibodies in terms of efficacy and safety of the two formulations applied to the first group of 27 covid-19 patients, reported the executive president, Dr. Román Macaya Hayes.
The hierarch explained that the CCSS Central Scientific Ethics Committee (CEC) endorsed the performance of this interim analysis of the “Randomized, controlled, double-blind, multicenter clinical study to compare the efficacy and safety of the administration of two formulations of equine immunoglobulins anti SARS-CoV-2 (“S” and “M”) in hospitalized patients with COVID-19 (SECR-01) ”.
Doctors Alfredo Sanabria Castro, principal investigator of the CCSS and Willem Bujan, sub-investigator of the University of Costa Rica (UCR), affirmed that the study is active and at this moment an interim data analysis is being carried out to determine if with From the existing results to date, it is possible to scientifically indicate whether there is a difference between the two formulations produced by the Clodomiro Picado Institute (ICP).
As explained by the researchers, “the administration of the serum was performed in hospitalized patients with moderate and severe SARS-CoV-2 infection, with less than 10 days of symptoms and in all cases with the presence of two or more factors of risk (high blood pressure, diabetes mellitus, heart disease, asthma, morbid obesity, smoking), which are predisposing to the development of a critical stage ”.
Sanabria indicated that most of the first participants have not completed the follow-up process established in the protocol approved by the CEC and made known to the National Health Research Council (CONIS).
For his part, Bujan commented that preliminary analyzes do not show that one of the two formulations is more effective than the other. There is also no evidence of a difference in safety, which suggests indicating an adequate tolerability of both research products.
Together the CCSS and the UCR will define study objectives and goals for the next stage. Other analyzes are required to determine the real capacity to achieve the desired efficacy of the intervention, which includes defining more specifically the treated population, the ideal dose and whether both formulations are maintained, the specialist explained.