The Ministry of Health of the Russian Federation has approved a Phase III international, multicenter, placebo-controlled clinical trial of the Russian branded medicine Polyoxidonium (azoximer bromide) to treat COVID-191.
On the back of the global COVID-19 pandemic, Petrovax is implementing a large-scale study program on Polyoxidonium to treat this condition. The company has launched an international, multicenter, adaptive, randomized, double-blind, placebo-controlled, comparator clinical study of efficacy and safety of Polyoxidonium® 6 mg, powder for solution for injection, for the treatment of hospitalized COVID-19 patients in Russia.
Concurrently, a clinical trial application for Polyoxidonium in COVID-19 patients is being reviewed by the French Ministry of Health. The filing in Slovakia is under preparation. Petrovax is also negotiating with regulators potential studies in other countries.
The multicenter Polyoxidonium study is conducted in accordance with the WHO Protocol2. In Russia, the study will embrace clinical sites in Moscow, Nizhny Novgorod, Orenburg, and Yaroslavl. It will assess the medicinal product’s efficacy and safety in adult COVID-19 patients (males and females) 18-85 years of age. At Stage 1 of the study, 100 patients will be enrolled. A total of 454 patients is expected to be included in Stages 1 and 2 of the study. Preliminary clinical results are expected in June.
The results from Polyoxidonium use studies in patients with infectious diseases suggest that the product may potentially be efficacious for the treatment of SARS-CoV-2-infected patients. There is the first successful experience of Polyoxidonium administration in COVID-19 patients in Slovakia. Based on that experience, the product has been entered into the national clinical guidelines for the treatment of COVID-19 patients3. We are proud that our study is the first and so far the only international, double-blind, placebo-controlled, clinical trial of a Russian branded medicinal product to treat the novel coronavirus infection.”
Apart from the international, multicenter clinical trial, Polyoxidonium is currently being used in routine clinical practice in COVID-19 patients in Russia, the CIS, and Slovakia, including within the framework of an observational study.
The company has also been donating Polyoxidonium as a preventive agent for the staff of some clinical sites.
Polyoxidonium® (active pharmaceutical ingredient: azoximer bromide) is a Russian branded medicinal product that has been widely used for 20+ years in clinical practice in Russia as well as exported to other countries. Presently, the product is authorized and is being used in 10 countries.
Polyoxidonium® is used both in adults and children older than 6 months of age for the treatment and prevention of inflammatory infections of viral, bacterial, and fungal origin at the stage of exacerbation and remission. The product’s mode of actions targets the immune system. Polyoxidonium® boosts the body resistance against local and generalized viral infections.
The product’s efficacy and safety have been confirmed in numerous clinical trials in a variety of therapeutic areas4. The company continues extending the product’s evidence base:
• Scientific papers on Polyoxidonium mode of action in vitro have appeared in international publications5,6
• The product has undergone double-blind, placebo-controlled clinical trials for influenza and ARVI7
• In 2019, a meta-analysis of clinical trials on Polyoxidonium® efficacy for the treatment of inflammatory respiratory infections in children and adolescents was published8
• In 2017, Petrovax received a report on a successful post-authorization safety study (PASS) of Polyoxidonium® in the EU (Slovakia)9,10
• The product has been authorized in Europe (Slovakia) and complies with all applicable EU regulations.
A total of 350+ scientific papers were published on Polyoxidonium, including those based on independent studies. The links to the scientific papers are provided below:
Polyoxidonium® is manufactured full-cycle, including API synthesis, in accordance with GMP standards at Petrovax’s state-of-the-art facility in Moscow region.