25 de enero de 2022
Gammaglobulina anti-SARS-CoV-2 muestra resultados alentadores en fase I de ensayos clínicos

Cuba shows positive results on anti-COVID Gammaglobulin clinical trial

Captain Beatriz Amat Valdes, principal investigator of the study carried out at the Central Military Hospital «Doctor Luis Diaz Soto», explained to the Cuban News Agency that the research began at the institution on July 19 and included 21 patients with severe disease, 10 corresponding to the control group and 11 to the group that received the drug.

The doctor clarified that there were no adverse events, none of the patients treated required ventilatory assistance and did not reach critical stages.

She also explained that after 72 hours the initial symptoms diminished and PCR was negatived, while pulmonary lesions were progressively reduced in X-ray studies.

Amat Valdes, who is also a specialist in Immunology and General Comprehensive Medicine, specified that the patients should meet several requirements, such as maintaining an oxygen saturation above 93 %, polypnea, that is, an increase in respirations of more than 25 breaths per minute and lesions in more than half of the lung fields.

The patients included had an evaluation period during days zero, three, five and seven, where blood was drawn and cellular parameters and inflammatory biomarkers were analyzed, in addition to CRP tests, X-rays and CT scans to evaluate the behavior of the lung lesions.

For her part, the MSc. Maritza Gonzalez Ramirez, from AICA Laboratories, said that the clinical trial was published on June 30, 2021 in the Cuban Public Registry of Clinical Trials and on July 7, the start authorization was issued by the Center for the State Control of Medicines, Equipment and Medical Devices, with the projection of requesting the authorization of a phase II trial and later the request for the authorization of the product’s use in emergencies.

She explained that the anti-SARS-CoV-2 gamma globulin is a product based on a concentrate of antibodies derived from a pool of plasma from virus convalescents, collected from volunteer donors who were classified as moderate, severe and critical during the infection.

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