Developers: | National Immunobiology Company (Natsimbio) |
Date of the premiere of the system: | 2021/04/01 |
Branches: | Pharmaceuticals, medicine, healthcare |
Main article: Drugs for coronavirus COVID-19
"COVID globulin" is a plasma-based medicine blood for people who have already undergone, coronavirus containing antibodies to it. The introduction of the drug helps the body overcome the disease and "teaches" the human immune system to quickly create antibodies on its own.
2021: Development of KOVID globulin
On April 1, 2021, Rostec announced that the Russian Ministry of Health approved the use of a specific immunoglobulin designed to treat coronavirus infection. The drug "KOVID-globulin" was created on the basis of blood plasma of sick Muscovites - for this, the capital transferred 2.5 tons of biomaterial.
The development of the Natsimbio holding of Rostec State Corporation during the research confirmed the safety, absence of side effects and the ability to neutralize the virus. It is assumed that it will be used to treat medium- and severe forms of the disease after the completion of phases II and III of clinical trials, which will be held, including on the basis of Moscow hospitals.
We present a registered drug of specific anticovid immunoglobulin. I note that it is not intended for prevention, but specifically for the treatment of coronavirus infection. The use of this drug will significantly expand the arsenal of doctors in the fight against COVID-19, "said Rostec Director General Sergei Chemezov. |
We continue to form a portfolio of domestic medicines for the prevention and treatment of COVID-19. Following, with Sputnik V vaccine a number of antivirals, drugs based on monoclonal antibodies that stop the cytokine storm, we have registered an immunoglobulin-based drug that will help severe patients receiving treatment in hospital settings. This drug will become an additional tool for protecting the health of our citizens during the coronavirus pandemic, the Minister said. health care RUSSIAN FEDERATION Mikhail Murashko |
Registration of the drug was obtained based on the results of preclinical and first phase clinical studies, which showed the safety of immunoglobulin, the absence of side effects and its neutralizing effect on the virus. The registration certificate allows the use of COVID globulin in patients aged 18 to 60 years.
The creation of the drug was carried out with the active assistance of the Moscow Department of Health. The metropolitan authorities carried out a lot of work, with the involvement of experts and practitioners to study the use of plasma by coronavirus patients as a raw material for the production of immunoglobulin.
To develop the drug, we handed over to Rostec 2.5 tons of plasma from donors ill with coronavirus. Thanks to the work carried out by Moscow clinicians in this direction, we gained a huge amount of knowledge about the properties and capabilities of plasma and were able to apply this knowledge in the development of a drug for coronavirus. This is why the second and third phase of the KOVID-globulin studies will be held with the participation of patients undergoing treatment in metropolitan hospitals. They will begin in early April 2021. Thus, the capital will be the first to be able to use the registered immunoglobulin drug intended for the treatment of coronavirus infection, "said Anastasia Rakova, deputy mayor of Moscow for social development. |
The second and third phases of clinical research will take about six months. At the beginning of April 2021, KOVID-globulin will be used only as part of research in hospitals in Moscow - for the treatment of patients with moderate to severe forms of the disease.
The total investment of Natsimbio Holding in the project will be up to 400 million rubles. The bulk of the funds will be for the purchase of raw materials, payment for clinical research, the purchase of equipment and consumables.
In addition to Moscow health care institutions, which have formed the largest supply of anticovid plasma in Russia, plasma will also be supplied by the Moscow Regional, Orenburg, Bashkir Republican, Sverdlovsk and other blood transfusion stations. In 2021, it is planned to process at least 15 tons of plasma - this should be enough to help 10-15 thousand patients.
The Moscow government began harvesting plasma from reconvalescent donors in early April 2020.