30 Dec 2021 10:00

Russian Health Ministry gives permanent registration to Covid-Globulin drug - Rostec

MOSCOW. Dec 30 (Interfax) - The Russian Health Ministry has granted permanent registration to the Covid-Globulin immunoglobulin drug, which is based on blood plasma from people who recovered from Covid-19, the press service for the Rostec State Corporation said on Thursday.

"This development of the Nacimbio holding of the Rostec State Corporation confirmed its efficacy, safety and ability to neutralize coronavirus during clinical trials. Based on the results of the trials, the Covid-Globulin drug has received a permanent registration certificate from the Russian Health Ministry," the press service said in a statement.

During the clinical trials, the use of Covid-Globulin in patients' therapy helped prevent complications such as cytokine storm, kidney insufficiency, thromboembolic complications, the development of acute respiratory distress syndrome and extensive lung damage in 70% of all cases and, on the whole, helped reduce the risk of more severe forms of the disease in seven out of ten cases, it said.

Notably, the drug proved to be most effective in the early stages of the disease, it said.

"Today, we can proudly announce the successful completion of the trials of the coronavirus drug - Covid-Globulin. The world's first special anti-Covid immunoglobulin drug passed the two final phases of the clinical trials, proving its safety and efficacy. This development by Nacimbio considerably broadens Russian medics' capabilities in fighting Covid-19. Now there are both possible forms of coronavirus immunization at their disposal: the active form, the vaccine, and the passive form, immunoglobulins," the press service quoted Rostec general director Sergei Chemezov as saying.

Covid-Globulin was approved by the Russian Health Ministry under the fast-track procedure on March 31 of this year. Its developer said at the time that the medication would be used to treat moderate to severe forms of Covid-19. According to the data available on the state register of permitted clinical trials, 460 patients took part in the Phase II and Phase III double-blind, placebo-controlled study of the drug's safety and efficacy.

The medication is being produced by a Perm-based enterprise of the Microgen Research and Production Association, which is a member of Rostec's Nacimbio pharmaceutical holding, using blood plasma from people who recovered from Covid-19 and were vaccinated against the disease. Nacimbio general director Andrei Zagorsky said in the press release that the Covid-Globulin drug uses only blood plasma from people with high Covid-19 antibody levels, while the technologies developed by the holding help guarantee a certain concentration of virus-neutralizing antibodies in every dose of this medication, a concentration which is higher "as compared to that in the starting material."

"The way Covid-Globulin acts is based on the properties of antibodies to neutralize existing coronavirus strains, i.e. strains that are circulating at the moment. Antibodies bind to the protein on the surface of the virus, stopping it from penetrating cells and thus blocking its spread in the body," the press service said.

The press service for the Mayor's Office and the government of Moscow said on November 4 that Moscow hospitals had already begun using this medication. In particular, blood plasma is being collected from donors with Covid-19 antibodies to be used in the production of Covid-Globulin. On November 1, payments to blood plasma donors were doubled to 10,000 rubles.