The first patients to receive the Equine Serum treatment this Monday are two men and two women, aged 43, 66, 67 and 77. “This is the randomized, controlled, double-blind, multicenter clinical study to compare the efficacy and safety of the administration of two formulations of equine anti-SARS-CoV-2 immunoglobulins (“S” and “M”) in hospitalized patients with COVID -19 (SECR-01),” said CCSS director Roman Macaya.
The treatment seeks to stop the spreading of virus in the human body as soon as possible with two main objectives: to lower mortality and to reduce the percentage of patients admitted to intensive care.
Macaya clarified that the treatment is in the research phase, and will initially begin with 26 hospitalized patients who must sign an informed consent. It will be applied in the San Juan de Dios, Mexico, and Rafael Ángel Calderón Guardia Hospitals and in the Specialized Attention Center for COVID-19 Patients (CEACO).
The estimated time of recruitment of patients is variable and will depend on whether they meet the inclusion criteria and the absence of exclusion criteria. It is expected that in one week to have most of the participants established in the protocol.
Macaya explained that in a few weeks the first results will be known since this is an acute disease. As he said, these antibodies can inhibit SARS-CoV-2 before it causes sequelae, “we are not going to avoid hospitalizations because this is not an outpatient treatment, patients who have just entered the hospital can recieve the treatment in order to slow down the evolution of the sequelae by the virus so that they do not reach the intensive care units”.
The director indicated that if this procedure is effective, it could lower mortality and decrease the percentage of patients admitted to intensive care, which would allow a better rotation of hospital beds.
Macaya highlighted the importance of having our own treatment, developed by Costa Rican scientists, “this is encouraging and this stage of clinical tests, in addition to being historical, fills us with optimism”.
“Starting to infuse a COVID-19 patient with a treatment developed in Costa Rica in a just few months shows the great capacity of the human resources that the country has, the great institution that is the University of Costa Rica and obviously the Costa Rican Social Security, this is a joint effort,” he added.
Equine Antibodies Shown To Inhibit Sars-Cov -2
The two equine antibody formulations developed by the Clodomiro Picado Institute are capable of inhibiting SARS-CoV-2, as revealed by analyzes carried out at the level 3 laboratory of George Mason University in the United States.
The treatment was carried out by inoculating six horses with various proteins of the virus. In total, the equines were injected four times with a two-week separation between each inoculation.
Dr. Macaya explained that every time a horse is injected, more immune reaction is generated, more antibodies, “by the fourth inoculation these horses are walking factories of anti-SARS-CoV-2 antibodies.”
The next step was the application of the treatment under a biomedical research protocol approved by the Central Scientific Ethics Committee of the CCSS. Later it was registered with the National Council for Health Research (CONIS).
According to the protocol, one bottle per patient will be applied and two horse antibody formulas will be tested. It is going to be compared if there is any difference in the clinical response of the patients. If the treatment is effective in COVID-19 patients, scale production will begin at the Clodomiro Picado Institute.
For Macaya, this project is very pragmatic since to increase production only requires more horses, “you do not have to build a new sophisticated factory” and commented that the scaling to 30 horses is already contemplated, “that would generate 25 thousand flasks by year”.
According to the official, “in the following weeks there will be many more COVID-19 patients, we have already exceeded 40 thousand accumulated cases, of that total, more or less 6 percent will be hospitalized, that is the universe of patients that we have to treat with these therapies”, he asserted.
Stop The Virus As Soon As Possible
Equine antibodies are directed at SARS-CoV-2, they will try to disable it, so that it cannot enter a human cell and thus multilpy, let’s say, the evolution of sequelae caused by this virus. The objective is to stop the evolution of the sequels.
“We are talking about a treatment to contain the advance to critical deterioration of people and also avoid subsequent sequelae,” said Macaya optimistically. He detailed that SARS-CoV-2 causes respiratory failure, kidney failure, multi-organ failure, blood clots, thrombosis, heart attacks, stroke, all this caused by a single virus, that is, it is affecting many body systems.
He drew attention to the fact that there comes a point where SARS-CoV-2 causes damage, generates sequelae and disappears, but the person can still die from these sequelae. “We have lost patients who were already tested negative for the virus, but were already in the ICU, fighting for respiratory failure, kidney failure and cytokine storm, that is, everything that triggered the virus,” said Dr. Macaya adding that the treatment seeks to stop the virus as soon as possible, so patients should receive treatment when they enter the hospital in moderate condition, “we do not want its sequelae to evolve because later it may be too late. These antibodies are designed to neutralize the culprit, the virus, but if it has already done the damage, it will not be reversible”.