Anti-SARS-CoV-2 gamma globulin: what are the projections with the drug? (Focus)

HAVANA, Cuba, Apr 5 (ACN) On September 19, 2021, the last patient was included in Phase I of the clinical trial with the anti-SARS-CoV-2 gamma globulin, a research conducted at the Doctor Luis Diaz Soto Military Hospital in Havana, with COVID-19 positive patients over 19 years of age.

The researchers of the AICA Laboratories Company along with the Ministry of Public Health are planning to start phase II of the study and request the authorization for emergency use of the product, for which they require a technical session between the two institutions, explained Maritza Gonzalez Ramirez, AICA's trial promoter, to the Cuban News Agency.

She explained that in the first stage of the research, the patients treated did not report serious adverse events related to the administration of the product, which evidenced its safety; in addition, neither was ventilatory assistance necessary, nor did they reach critical stages.

The results, she added, showed an antiviral response that was manifested through the PCR negativization time and an anti-inflammatory response with the systematic decrease in the neutrophil/lymphocyte index and C-reactive protein parameters.

In order to initiate phase II of the clinical trial and obtain authorization for use in emergencies, the final report of the trial was submitted to the Center for State Control of Medicines, Equipment and Medical Devices, which notified its approval on March 15, 2022, Gonzalez Ramirez pointed out.

She mentioned that this research phase will be carried out at several clinical sites and will include 120 patients over 19 years of age, which will make it possible to obtain more accurate results and to test the antiviral effect and the anti-inflammatory response of the anti-SARS-CoV-2 gamma globulin.

However, the study's promoter pointed out, they could have the authorization for emergency use without initiating phase II, due to the encouraging results in phase I and the need to continue treating serious and critical patients.

The specialist recalled that the product is a blood-derived medicine obtained at the plant of the Business Plant of Serum and Blood Derivatives, belonging to AICA Laboratories, from voluntary blood donations from convalescent patients of the COVID-19.

The drug is based on a concentrate of antibodies derived from a pool of plasma from patients convalescing from the virus, collected from voluntary donors who during the infection were classified as moderate, severe and critical, as well as from recovered, asymptomatic and mild symptomatic patients, with low antibody titers, but who were immunized with Cuban vaccines.
Anti-SARS-CoV-2 gamma globulin follows the production platform of Intacglobin (human immunoglobulin) manufactured in the same production facility, which concluded.