There have been hundreds of thousands of deaths from COVID-19 around the world in the millions of cases that have been proven so far. The world has been desperate for COVID-19 drugs that work. Because of the pandemic, people all over the world are working hard to find new uses for drugs that have already been approved for other uses. There are now vaccines available, but getting everyone in the world vaccinated will take a global effort. Even with vaccines, it looks like we will have to get them every year in the future. Could an easy-to-make small polymeric chemical from the 1970s and 1980s help us find a new way to get through the COVID-19 pandemic?
The drug industry has responded very strongly to our calls for "repurposing," which means looking into using approved drugs to treat new diseases. Clinical trial activity has gone through the roof, and the business is almost running out of resources because they have all been put to use. As expected, clinical studies are being done on a number of antiviral drugs that have already been used to treat SARS, MERS, HIV/AIDS, and malaria. Because COVID-19 is putting so much stress on health systems around the world, WHO has set up the "Solidarity" international clinical study to help find a good way to treat it. Some of the most important drugs to come out of this process are the antiviral remdesivir, the malaria drugs hydroxychloroquine and chloroquine, the HIV drug combination Kaletra, and many others, such as interferon beta-1a. But the results have been nothing but depressing. Both business and medical professionals alike have been left scratching their heads.
Enter azoximer bromide (AZB; Polyoxidonium®), an adjuvant for use with hemagglutinin glycoprotein-based influenza vaccine (Grippol®). Before Perestroika the State Scientific Center of the Institute of Immunology of the Ministry of Health of the Russian Federation (now the FSBI State Scientific Center "Institute of immunology" FMBA of Russia) was focused on identifying adjuvants for flu vaccines, enhancing the potentiation of immune responses to infection. As the Iron Curtain fell the Russian team commercialised their findings in the form of azoximer bromide (AZB; Polyoxidonium®) [1]. As of now, different kinds of the adjuvant-glycoprotein mix have been used a lot in Russia and other CIS countries since the early 2000s. The adjuvant azoximer bromide is thought to have been used in more than 400 million doses of vaccine. Azoximer bromide was known from the start to be an immunity modulator drug, but it is not well known or used in the West. Since this is the case, a lot of research (mostly in Russian) has shown that it can make a host more resistant to both local and general infections. It is often used to treat viral illnesses.
Doctors in what used to be known as the "Eastern Block" (Russia, Slovakia, Georgia, Belarus, Ukraine, Kazakhstan, and Uzbekistan) turned to Polyoxidonium® as the pandemic hit. They used it to supplement the standard of care for hospitalised patients and for themselves as a preventative measure so they could "keep the lights on" even though clinical teams on the front lines were getting sick. At this point, Petrovax, the company that makes Polyoxidonium®, conducted a clinical study with azoximer bromide to see if it could help fight COVID-19. The findings of the first of those studies has been reported in the journal ‘Drugs in Context’. The trial tested Polyoxidonium®, Petrovax’s injectable formulation of the immunomodulator azoximer bromide (AZB) in 32 hospitalised COVID-19 patients. The open-labelled trial assessed the efficacy and safety of inhaled Polyoxidonium® as a therapy for patients hospitalised with COVID-19 identified as being severe on entry. In addition to standard of care treatment, patients received 12 mg of intravenous AZB once daily for 3 days, followed by AZB 12 mg intramuscularly every other day for 13 days until discharge. The primary outcome was change in clinical condition using the Ordinal Scale for Clinical Improvement (OSCI), specified as the primary endpoint in the WHO Master Protocol. Azoximer bromide was well tolerated and all patients were alive and discharged with normal oxygen saturations with no secondary infections or delayed mortality reported.
Positive top line results include reductions in mean OSCI and National Early Warning Score values following treatment with azoximer bromide. A decrease in OS score was marked in patients identified as severe on recruitment [2]. Clearly, further appropriately controlled studies are necessary to determine whether these observations reflect a clear clinical benefit. It is expected that data from a larger international, multi-centre, randomised placebo-controlled study with azoximer bromide in 400 hospitalised patients that is currently being analysed will confirm whether a simple polymeric small molecule developed during the 1970s and ‘80s pave a novel path out of the COVID-19 pandemic [3].
References
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