From volunteer blood donations done by Covid-19 convalescents, the Empresa Laboratorios AICA, in a joint effort with the Ministry of Public Heath(MINSAP), developed a clinical trial with anti-SARSCOV2 Gammaglobulina product that showed encouraging results at phase I of clinical trials attending to its safety, the decrease in the lung damage and the negativization of the viral load.

Captain Beatriz Amat Valdéz, principal investigator of the study, that was carried out at the Hospital Militar Central ´Doctor Luis Díaz Soto¨ explained that they began the research in the institution on July 19th in which were included 21 critical Covid-19 patients, 10 patients corresponded to the control group and 11 to the group that was shot with the Gammaglobulina immunogenic.

Amat Valdéz pointed out that there were no reported any adverse events, none of the patients that were treated required ventilation assistance and any of them reached a critical status. It was also observed that within the 72 hours after the administration of the drug, a decrease in the symptoms was observed, reaching the negativization of the PCR (Polymerase Chain Reaction) while a progressive reduction in the lung injuries was evident during the imaging studies.

Amat Valdéz who is also an Immunology and General Integral Medicine specialist, added that, there were included to the study, Covid-19 positive cases confirmed through PCR, over 19 years of age and under the condition of being at the tenth day of their evolution after the appearance of the symptoms, and complying with the criteria stablished by the Covid-19 National Acting Protocol in its 1.6 version.

These protocols are related to the need of oxygen in order to set a saturation over 93% which is the polypnea, translated as an increase of respiration over 25 breaths/per minute with lesions in more than half of the lungs´ area.

Pregnant women, patients with respiratory aid, with self-immune diseases, liver diseases, acute heart diseases, terminal cancer, previous thrombotic events, immunoglobulin A selective deficit(IgA), body mass above 30 and patients that were treated with monoclonal antibodies and blood derivative a month prior of the administration of the product were excluded of the trial.

In regard with the control group, Valdés pointed out that patients in the essay were administrated with the medicine stablished at the National Acting Protocol:

Patients included had an incubation period during days 0,3,5 and 7 and their blood was extracted and blood parameters and inflammatory biomarkers tested, among them, PCR tests, X-rays, CT-SCAN in order to evaluate the behavior of the pulmonary lesions.

Maritza González Ramirez, PhD. in Sciences, and worker of the Empresa Laboratorios AICA, institution that promoted the investigation, stated that the clinical trial was published on June 30th, 2021 at the Registro Público Cubano de Ensayos Clínicos(Public Cuban Record of Clinical Trials) and on July 7th ,the clearance for the beginning of the essay was emitted by the Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Medicos(CEDMED)(Center for the State Control of Medicine, Equipment and Medical Devices) under the aim of requesting the clearance for a clinical trial phase II and the later authorization for emergency use of the product.

She detailed that the anti-SARSCOV 2 Gammaglobulina is a blood-derivative manufactured at the UEB Sueros y Hemoderivados (UEB SH), that belongs to the Empresa Laboratorios AICA. The product is based on an antibodies concentrate derived of a pool of plasma from Covid-19 convalescents, which was collected of volunteer donates that were classified as moderated, severe and critical during the infection.

Likewise, this product also comes from recovered Covi-19 patients, asymptomatic and slightly symptomatic ones, with low antibodies titles which where immunized with Soberana Plus vaccine as for convalescents with lower inhibition titles, although with a demonstrated antibodies presence.

The specialist also affirmed that anti –SARSCOV 2 Gammaglobulina follows the production platform of the Intacglobin (human immunoglobulin), manufactured by the same productive company and with more than 30 years positioned in the market, with safety and efficiency guarantee.

She highlighted that UEB SH owns the necessary capacities for the increasing of the production of this medicine, although volunteering blood donations are not enough for getting this result.

Dr. Delia Esther Porto González, head of the National Blood Program of the MINSAP, mentioned the experienced that Cuba has in blood –derivate medicine and specially in the gammaglobuline production.

Over several decades in the country immunoglobulin anti-hepatitis B is produced, obtained from people who are immunized with Heverbiovac-HB vaccine. We also count with the anti-tetanic immunoglobulin and the anti-D, applied to pregnant women that belong to the negative Rh blood group in order to prevent hemolytic disease in newborns.

The also specialist in Hematology commented that through the volunteering donations it is possible to keep the plasmapheresis program, mechanical program through which blood components are separated and plasma, platelets, leukocytes and erythrocytes are obtained.

At the same time, the albumin is obtained that is a protein used in oncologic diseases, faming patients or burned patients, chronic nephrotic patients and alcoholics, and the so called Intacglobin.

Blood donating is an act of love and a gesture during which people become anonymous heroes. With only one donation for lives can be saved and relieves the country of spending millions through the production of medicine and blood derivate that directly affect medical assistance.

Taken from MINSAP 

 [Y1]