The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study

Abstract

A clinical need for aetiotropic coronavirus disease (COVID-19) treatments is required. The immune modulator azoximer bromide (AZB; Polyoxidonium®) is indicated in Russia for use against acute viral infections and during remission. In this study, adults hospitalized with COVID-19 ( n =32) received AZB and standard of care in an open-label, multicentre, interventional study. All patients were symptomatic; 22 had severe disease (National Early Warning Score ≥5) and required mechanical ventilation or oxygen saturation (SpO 2 ) and 19 patients had co-morbidities. Patients received AZB 12 mg intravenously once daily for 3 days, then intramuscularly every other day (approximately ten injections) until discharge. The primary endpoint was the patient’s clinical status (7-point Ordinal Scale; OS) on day 15 versus that at baseline. The mean duration of hospitalization was 20 days. All patients were alive and discharged with normal SpO 2 with no secondary infections or delayed mortality reported by the end-of-study visit (on day 28–72). A decrease in the mean OS and National Early Warning Score values was observed following treatment with AZB. A decrease in OS score was marked in patients identified as severe. Both sets of patients achieved similar scores, which can be classified as an improvement by day 9–10; SpO 2 levels trended to normalization over time. By day 11–12, all patients had a normal body temperature. Serum C-reactive protein levels decreased in patients with severe and mild disease. Most patients had signs of pneumonia at baseline ( n =27), with the majority recovering by days 10–12. No major toxicities were observed. AZB was safe and well tolerated when administered in addition to standard of care treatment for COVID-19. Further randomized, placebo-controlled studies are needed to elucidate any potential therapeutic effect in COVID-19.

Azoximer bromide and hydroxyapatite: promising immune adjuvants in cancer

“…AZB (12 mg IV once daily for 3 days then IM every other day until D17) has been prescribed to COVID-19 patients in Slovakia and Russia as part of licensed therapy. Phase II studies involving 84 patients were conducted in Russia and historically compared to the control arm of a randomized study in China with matched bio-clinical characteristics 59 , 60 . This protocol was reviewed and approved by an Independent Ethical Committee (Pharmnadzor, REC number 229; 9 April 2020).…”

Azoximer Bromide: Mystery, Serendipity, and Promise

“…Initially, reports started to emerge on the prophylactic use of AZB in physicians and healthcare teams working directly with patients, and later in observational studies conducted on patients presenting at hospital (49)(50)(51). Although not made as part of formal studies, these observations indicated possible benefits of AZB in COVID-19 that warranted further investigation.…”

“…Although not made as part of formal studies, these observations indicated possible benefits of AZB in COVID-19 that warranted further investigation. An appropriately powered, a well-controlled study was designed and is currently underway (49).…”