11 Clinical Sites Have Joined the Study of the Russian Drug against COVID-19

15 May 2020

GMP News

The Ministry of Health of the Russian Federation approved the participation of 11 healthcare centers in the clinical trials of the Russian drug with the INN levilimab. Let us remind that, according to the Interim Guidelines for the Prevention, Diagnosis and Treatment of COVID-19 of the Ministry of Health of Russia, mortality in COVID-19 is associated, inter alia, with an increase in interleukin-6 levels.

According to Nikita Lomakin, Chief Researcher, Central Clinical Hospital of the Presidential Administration of the Russian Federation, a positive and almost unique characteristic of the clinical trial protocol is that the study includes patients with moderate disease with first clinical signs of respiratory failure. “Not only a molecule new to COVID infection, but a fundamentally different approach to managing these patients compared to current recommendations allows not treating but preventing the development of the cytokine storm. Moreover, based on the experience of our center, it seems that the main predictor of its development is not the laboratory data, but the clinical course of the disease. The use of levilimab at the very beginning of clinical manifestations of respiratory failure helps prevent the necessity to transfer patients to the intensive care unit. We managed to discharge 10 out of 36 patients as early as on day 7-8, with 1 patient being transferred to intensive care,” the doctor said.

“Within a single day, on May 7, just a few days after the publication of the forthcoming start of clinical trials of the inhibitor levilimab, seven healthcare institutions expressed their wish to participate in the trials”, said Dmitry Morozov, CEO of the Biotech Company BIOCAD. “Such high specialists’ confidence in the domestic drug is for us, among other things, an indicator that we have chosen the right strategy and our new drug can greatly help people with coronavirus complications in the near future.”

Levilimab is the Russian original IL-6 receptor inhibitor. Previously, the biotech company BIOCAD received approval from the Ministry of Health to conduct a clinical study of levilimab in patients with severe coronavirus infection.

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