The Ministry of health has approved a clinical trial phase III of the drug Polyoxidonium (bromide anoxemia) among patients with coronavirus infection. The efficacy and safety of a drug is compared with placebo, reported at the Petrovax.
In connection with the global pandemic coronavirus “of Petrovax” is implementing an ambitious program of research anoxemia bromide at COVID-19. The company launched an international multicenter, double-blind, placebo-controlled, adaptive, randomized, comparative study of the efficacy and safety of the drug in the treatment of hospitalized patients with COVID-19 in Russia.
At the same time the application for conducting clinical studies of the drug in patients with COVID-19 is seen in the Ministry of health in France and is preparing a submission in Slovakia. Also, “Petrovax” in talks with regulators about conducting research in other countries.
In Russia in the clinical trial will involve clinical centers in Moscow, Nizhny Novgorod, Orenburg and Yaroslavl. It will assess the efficacy and safety of the drug in adult patients (men and women) aged 18 to 85 years with COVID-19. In the first phase of the study will be included 100 patients. In General, taking into account the two phases of the study is scheduled to be held involving 454 patients. First results of the study are expected in June.
The results of studies of the drug in patients with infectious diseases show that the drug could potentially be effective for the treatment of patients with the coronavirus SARS-CoV-2. It is the first successful application in Slovakia with coronavirus infection COVID-19, under which the drug is submitted to the clinical guidelines of the country for the treatment of patients with COVID-19.
In addition to MMKI currently Polyoxidonium is applied in daily clinical practice in patients with COVID-19 in Russia, CIS countries and Slovakia, including in the framework of observational studies.