The multicenter clinical trial “Polyoxidonium” is carried out in accordance with the WHO Protocol – the recognized gold standard for clinical trials. This is the only original Russian drug approved by EU regulators, and the first Russian drug that received approval in March 2020 from the Ministry of Health of the Russian Federation for IMCT in the treatment of patients with coronavirus infection.
The results of the study are expected in the summer of 2021. According to the results of the study, the Russian original development can claim a unique status – a drug against COVID-19 with proven efficacy in IMCI.
Currently, there is a successful experience of using “Polyoxidonium” in COVID-19 both in Russia and the EU. The drug is used for the preventive protection of doctors working in the “red zones”, and is also being studied in open observation programs in patients with COVID-19-19. In Slovakia, the drug was included in the clinical guidelines for the treatment of patients with coronavirus infection.
According to a special permit issued by the Ministry of Health of Slovakia in 2021, Petrovax delivered 5 thousand packages of Polyoxidonium tablets to the University Hospital named after L. Pasteur (Slovakia) for the prevention and treatment of coronavirus infection within the framework of state health insurance. According to the document, the therapeutic use of the drug is allowed in medical institutions in Slovakia for the purpose of immunoprophylaxis of coronavirus infection in medical workers and treatment of patients with COVID-19. As part of a social initiative, during 2020, Petrovax handed over more than 20,000 packages of Polyoxidonium to Russian doctors working in the “red zones” to prevent coronavirus infection.
Petrovax President Mikhail Tsyferov: “We have always highly appreciated the potential of our original drugs, therefore, in 2020 we launched a large-scale research program “Polyoxidonium” at COVID-19-19. The start of an international study is a logical continuation of our strategy for the development of a drug at the international level according to the highest standards of evidence. IN study leading experts around the world are involved, we are developing partnerships with dozens of foreign scientific laboratories and institutes. Hope a successful completion IMCT will be a new chapter for us in the history of Polyoxidonia, will help in the fight with crowna viral infection and will open up new prospects for Russian products on the global market. “
More about research
The international multicenter clinical trial of Polyoxidonium (Azoximer bromide) was launched by Petrovax in April 2020. The main objective of the study is to assess the efficacy and safety of the drug in adult patients aged 18 to 85 years, hospitalized with COVID-19.
In July 2020, the first of two stages of the international clinical trial “Polyoxidonium” was completed, which confirmed the high safety profile of the drug in the treatment of patients with COVID-19. Following the first stage, the Independent International Data Monitoring Committee the effectiveness and safety of clinical trials (Data and Safety Monitoring Board), consisting of Russian and European experts, recommended expanding the number of participants and adding patients with severe coronavirus infection to the study group. Slovakia joined the international survey last November.