The study evaluated the efficacy and safety of Polyoxidonium injections as a therapy in hospitalized patients with COVID-19. As part of the complex therapy, patients received 12 mg of “Polyoxidonium” (lyophilisate for the preparation of a solution for injection and external use) intravenously once a day for three days, and then intramuscularly once every two days (from 4 to 16 days) with a total course of 10 injections …
The primary endpoint according to the WHO master protocol was the change in patient status on day 15: a 7-point ordinal scale for assessing clinical status was used for the assessment. In patients admitted to the hospital in serious condition, an improvement in clinical status was noted during therapy. Polyoxidonium® was well tolerated; all 32 patients included in the interim analysis survived and were discharged with normal blood oxygen saturation levels. At the end of the study (28–72 days), patients had no secondary infections or delayed mortality. During the use of “Polyoxidonium” there was an improvement in the condition of patients, a decrease in symptoms, a gradual withdrawal of patients from oxygen support. These parameters were also assessed according to the National Early Warning Scale (NEWS) (determines in total points the main indicators of the state of the body: pulse, respiration, temperature, blood pressure, etc. and their deviation from the accepted norm). A significant improvement according to the NEWS scale was observed on average as early as on the 9th day of therapy, including in severe patients.
Mikhail Tsyferov, President of Petrovax: “The publication of our research data in the peer-reviewed journal Drugs in Context is an important milestone in the formation of the evidence base for Polyoxidonium®. The immunomodulator has been widely used in Russia and abroad for more than 20 years. We believe that Polyoxidonium® may become a necessary drug for the treatment of COVID-19. At the moment, our team, in cooperation with partners and with the support of regulatory authorities, is fully focused on completing an international Phase III clinical trial that we are conducting in Russia and Slovakia. “
Jean-François Rossi, Professor of Hematology at the University of Montpellier and Principal Investigator: “The study results support our view that azoximer bromide, a well-known drug approved for injectable use for other indications, can be used to restore the body’s immune response and accelerate recovery from COVID-19. This drug, with a good reputation and excellent tolerance, supports the patient by strengthening the body’s defenses. Moreover, the drug does not have a specific direct effect on the virus itself. This could be an added benefit when treating COVID-19 caused by new variants of the SARS-CoV-2 virus that are not affected by antiviral drugs, or when treating SARS-CoV-2 co-infection with other respiratory viruses such as influenza or respiratory syncytial virus that can be encountered in the likely subsequent waves of disease, presumably in the winter of 2021–2022. “
Full publication title: The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19) -19): an open-label, multicenter, interventional clinical study).
Scientific publication is available at the link: