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

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Authors
Sergey V Efimov, Natallia V Matsiyeuskaya, Olga V Boytsova, Lyudmila Yu Akhieva, Elena I Kvasova, Francisco Harrison, Yulia S Karpova, Anton Tikhonov, Nadezhda F Khomyakova, Tim Hardman, Jean-François Rossi

Article Type
Original Research

DOI
10.7573/dic.2020-11-1

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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 respiratory support 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 oxygen saturation (SpO2) 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; SpO2 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.

Keywords: azoximer bromide (Polyoxidonium®), COVID-19, inflammation, interventional study.

Citation: Efimov SV, Matsiyeuskaya NV, Boytsova OV, Akhieva LY, Kvasova EI, Harrison F, Karpova YS, Tikhonov A, Khomyakova NF, Hardman T, Rossi J-F. The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study. Drugs in Context 2021; 10: 2020-11-1. DOI: 10.7573/dic.2020-11-1

Trial registration: The trial is registered on ClinicalTrials.gov (NCT04542226).

Contributions: All authors contributed equally to the preparation of this review. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: Yulia Karpova, Anton Tikhonov and Nadezhda Khomyakova are employees of NPO Petrovax Pharm, Russia. The authors declare that they have no other conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2021/03/dic.2020-11-1-COI.pdf

Acknowledgements: We are grateful to Nikolay S Dodonov, Tatyana A Kireeva, Altana V Mikhakhanova, Ekaterina I Zvorykina, Anna N Kochanova, Liana S Badalyan, Karina I Khambalova and Vasiliy V Gaevskiy for for their excellent technical assistance.

Funding declaration: This work has not received any external funding or has been supported by any external grants.

Copyright: Copyright © 2021 Efimov SV, Matsiyeuskaya NV, Boytsova OV, Akhieva LY, Kvasova EI, Harrison F, Karpova YS, Tikhonov A, Khomyakova NF, Hardman T, Rossi J-F. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2021 Efimov SV, Matsiyeuskaya NV, Boytsova OV, Akhieva LY, Kvasova EI, Harrison F, Karpova YS, Tikhonov A, Khomyakova NF, Hardman T, Rossi J-F. https://doi.org/10.7573/dic.2020-11-1. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/the-effect-of-azoximer-bromide-polyoxidonium-in-patients-hospitalized-with-coronavirus-disease-covid-19-an-open-label-multicentre-interventional-clinical-study

Correspondence: Professor Jean-François Rossi, Institut Sainte Catherine, 84918 Avignon, France. Email: jeanfrancoisrossi@me.com

Provenance: Submitted; externally peer reviewed.

Submitted: 3 November 2020; Accepted: 10 January 2020; Publication date: 25 March 2021.

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