Petrovax expands the number of countries participating in the international clinical trials of Polyoxidonium® according to WHO protocol, after the successful completion of the first phase in Russia.
Petrovax has started recruiting Slovakian patients for participation in an international multicenter placebo-controlled clinical trial of the efficacy and safety of Polyoxidonium®
(INN: Azoximer bromide) for treating COVID-19. The Ministry of Health of Slovak Republic has approved the inclusion of 25 patients in the trials at the medical centers of four cities: Košice, Nitra, Trnava and Banská Bystrica. Russia has currently over 300 hospitalized patients with COVID-19 involved in the study.
According to the protocol, patients are randomly assigned into two groups: one of them includes Polyoxidonium®
in the treatment regimen, the second group receives a placebo instead of the real drug along with the recommended therapy.
According to the Johns Hopkins University (USA), Slovakia has a total of 97 493 recorded cases of COVID-19 on November 20, 2020. Slovakia has already successful used Polyoxidonium for COVID-19 and the medicine has been included in the country's clinical guidelines for treating patients with coronavirus infection. Over six months in 2020, 25 thousand packages of Polyoxidonium has been delivered to Slovakia (in lyophilisate form for hospitals).
“Polyoxidonium® has already received recognition from doctors in Slovakia for treating COVID-19, and we are glad that medical centers in this country are joining our research project. We are also planning to soon start recruiting patients in other countries and expand the number of participants to 454. The WHO protocol of our research allows us to study Polyoxidonium® according to the highest standards of evidence-based medicine”.
Mikhail Tsyferov, President of Petrovax
“We are delighted to become part of the international clinical study of Polyoxidonium®. That drug has reached such a high level by virtue of the professionalism of health workers and researchers from many countries. From now on, Slovakia will cooperate with the other nations participating in the study of the drug’s efficiency and safety. That way we hope to make a meaningful contribution to fighting the pandemic and hasten the victory over COVID-19”.
President of Slovak Society of Infectious Diseases, member of National Committee for Antibiotic treatment and member of National DRG board at Ministry of Health Pavol Jarčuška
In April, Petrovax launched international trials to study the clinical efficacy and safety of Polyoxidonium®
compared to a placebo in hospitalized adults (men and women between 18 to 85 years) diagnosed with COVID-19.
During the first phase in July, an independent review committee confirmed the results that Polyoxidonium has a high safety profile in the treatment of COVID-19 patients. Hundred patients from 18 healthcare facilities in Moscow, Orenburg, Nizhny Novgorod, Yaroslavl, Barnaul, Vladimir, Saint Petersburg, Ryazan and Ivanovo took part in it
. An independent international committee recommended expanding the study group and adding patients with severe course of coronavirus infection. The preliminary results of the second phase to study the effectiveness of the medicine are planned to come out in Q1 2021.
became the first original medication in Russia that was approved by the Ministry of Health of the Russian Federation for the international multicenter placebo-controlled clinical trial in treatment of patients with coronavirus.