"Indicated for the development of a cytokine storm": the Ministry of Health has registered a new drug for the treatment of complications from COVID-19

The Russian Ministry of Health has registered another drug for the treatment of COVID-19 - Levilimab (the trade name is Ilsira).

As reported on the agency’s website, this is the second drug registered under the accelerated procedure stipulated by the government decree of April 3, 2020 No. 441, which regulates the specifics of the treatment of drugs in the face of the threat of emergencies and emergency response.

"The drug is indicated for patients with a severe course of the disease when the so-called cytokine storm develops," the agency said.

A cytokine storm, or hypercytokinemia, is an excessive inflammatory reaction of the body to the introduction of the virus, which leads to damage to tissues and organs, in particular, lung tissue, to a severe course of infection with a possible fatal outcome.

In particular, it can occur if the patient has elevated levels of interleukin 6 (IL-6), which stimulates the immune response. Levilimab is one of the drugs that inhibit IL-6.

Prevention of the development of a cytokine storm is extremely important in the treatment of COVID-19, the Ministry of Health emphasized.

Levilimab is produced by the Russian biotechnological company Biocad. The general director of the company, Dmitry Morozov, with whom RT spoke in May, then explained that the drug was originally created specifically for the treatment of rheumatoid arthritis.

“But since the world has experience using this type of drug to treat patients with COVID-19, we repositioned it there and started clinical trials,” he told RT.

Morozov emphasized that Levilimab is a completely original development and is intended for subcutaneous administration.

“Fully molecules are made in our company, this is not a copy, not a generic and not an analogue,” he said.

Within the framework of clinical trials, the company's specialists interacted with the Central Clinical Hospital of the Administrative Department of the President of Russia.

“Our colleagues have developed their own regimen for the use of this drug and began to use it based on the clinical picture. As soon as they see that a person has a small shortness of breath or other signs of COVID-19 disease that can develop into aggravating conditions, they began to use it ahead of schedule, ”Morozov said.

It is worth noting that the drug at the stage of clinical trials has already been used in hospitals, since its studies as drugs for rheumatoid arthritis have already proved that it is not dangerous to humans. 

Doctor of Medical Sciences, Professor, Head of the Laboratory for Vaccine Prevention and Immunotherapy of Allergic Diseases, I.I. Mechnikov Research Institute of RAMS Mikhail Kostinov, in a conversation with RT, noted that when a virus enters the body, a reaction called non-specific protection occurs. With it, a large number of pro-inflammatory mediators are released that are aimed at combating the virus, in particular, interleukin 6.

“But among older people, this mechanism is developing so quickly that it is impossible to inhibit it so that antibodies begin to form. Antiviral drugs are not enough, because they kill the virus, but do not help form antibodies. And the immune response should always go in two phases: the first is non-specific, and then specific. And it turns out that there are so many of these mediators that necrosis begins. Then a cytokine storm occurs - a state where immunity devours its own tissues. In such cases, special drugs are introduced that suppress the synthesis of these inflammatory mediators, ”the expert explained.

In May, doctors from the Tver Regional Hospital, who took part in the shooting of Anton Krasovsky's film “Survive After IVL,” also explained that the cytokine storm is a sharp increase in cytokines, molecules that regulate the body’s immune response. This leads to an attack of immunity on the cells of your own body. In this state, many serious patients with a diagnosis of COVID-19 were admitted to the institution.

In such cases, the patient can also help the drug "Actemra" (Tocilizumab) - an agent against vasculitis of large vessels. The mechanisms of action of this substance and Levilimab are identical. The hospital noted that the drug is most effective if you enter it in advance, before the onset of a critical condition.

Since hypercytokinemia is one of the common complications of COVID-19 disease, from the beginning of the pandemic, a number of foreign countries began to use drugs that help with this condition to treat patients with coronavirus. Thus, the National Health Commission of China in March in updated recommendations for the treatment of the disease indicated that tocilizumab can be used in the treatment of severe patients with high levels of IL-6 and extensive lung damage. Beijing has included the drug in clinical trials involving about 200 subjects with COVID-19.

Also in March, the Italian edition of La Republica, citing local doctors, reported that patients with COVID-19 showed positive results with tocilizumab therapy. According to Vincenzo Montezarcio, an infectious disease specialist at a hospital in Naples, the country's medical institutions requested approval of this treatment option COVID-19 by the Italian Medicines Agency (AIFA).