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Hind Al Soulia - Riyadh - MOSCOW — The Russian Ministry of Health recently registered COVID Globulin — the world's first medication based on a coronavirus-specific immunoglobulin.
It was developed on the basis of blood plasma of cured Moscovites, which was transferred for this purpose by the city in the amount of 2.5 tons.
This solution by Rostec's Nacimbio was tested and proved its safety, absence of side effects, and the ability to neutralize the novel coronavirus.
The drug is intended for treating medium or strong cases upon completion of Stage 2 and Stage 3 of the clinical trials to be conducted in hospitals, including those of Moscow.
"We are glad to present the world's first ever registered medication based on a COVID-specific immunoglobulin. I need to point out that this medication is specifically intended for COVID treatment rather than prevention.
“This new solution will greatly expand the doctors' toolkit to treat COVID-19. In fact, Russia is among the first countries to apply both types of anti-coronavirus immunization – passive (immunoglobulin) and active (vaccine)," said Sergey Chemezov, Rostec CEO.
COVID Globulin is a medication based on blood plasma of people already cured from coronavirus and thus containing specific antibodies.
Administration of COVID Globulin helps the organism to fight the disease and train the immune system to synthesize antibodies independently.
“We continue to make a portfolio of domestic medication for the prevention and treatment of COVID-19.
“Following the world's first Sputnik V vaccine, a number of antiviral agents, medication based on monoclonal antibodies that stop the cytokine storm, we were the first to register an immunoglobulin-based medication that will help critically ill patients in a hospital.
“The new medication will become an additional tool to protect the health of our citizens during the coronavirus pandemic, ” said Mikhail Murashko, minister of health of the Russian Federation.
The medication was registered upon submission of successful results of the pre-clinical trials and Stage 1 of clinical trials, which demonstrated its safety, absence of side effects, and the ability to neutralize the new coronavirus.
The Registration Certificate approves the use of COVID Globulin for patients aged from 18 to 60.
The drug development has been proactively supported by the Health Department of the Moscow government. The Moscow officials have managed to involve a lot of experts and hospital doctors into the testing of blood plasma that was donated by cured patients as a feedstock to produce the specific immunoglobulin.
For this purpose, the Moscow Health Department transferred to Rostec (Nacimbio) 2.5 tons of donor plasma and now provides venues to conduct Stage 2 and Stage 3 of the clinical trials.
"To develop this unique drug, we transferred to Rostec 2.5 tons of blood plasma donated by COVID-convalescent donors. Thanks to Moscow clinical doctors, we have gained a vast stock of knowledge on the plasma characteristics and potentials and managed to apply them for the coronavirus treatment.
“This is a reason why the 2d and 3d stages of the COVID Globulin trials will be conducted in Moscow hospitals. They will start in early April, this year.
“Thus, the capital of Russia will be the first to use the world's first ever immunoglobulin targeted for the novel coronavirus disease," said Anastasiya Rakova, Moscow Vice Mayor for Social Development.
Stages 2 and 3 of the clinical trials will take about six months. Currently, COVID Globulin is intended for use only in Moscow hospitals participating in the trials — for medium or strong cases.
Nacimbio's total investments into the initiative will amount up to 400 million rubles. Most funds will be used to purchase feedstock, fund the clinical trials, and buy related equipment and consumables.
In addition to Moscow healthcare institutions that have gained Russia's largest stock of anti-COVID plasma, such plasma will be supplied by the Moscow regional, Orenburg, Bashkiria, Sverdlovsk, and other blood donor centers.
In the current year, we plan to process at least 15 tons of plasma — which will be sufficient to help 10,000 or even 15,000 patients.
Antibody-based drug therapy is widely used throughout the world and has numerously proven its efficacy in treating various infectious diseases, such as hepatitis B, tick-borne encephalitis, tetanus, etc. — SG
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