Open-label use of an aliphatic polyamine immunomodulator in patients hospitalized with COVID-19

Drugs in Context

article

Sergey V Efimov¹  Natallia V Matsiyeuskaya²  Olga V Boytsova³  Luydmila Yu Akhieva⁴  Elena V Kuntsevich⁵  Anastasia A Troshina⁶  Elena I Kvasova⁷  Anton A Tikhonov⁸  Nadezhda F Khomyakova⁸  Francisco Harrison⁹  Jean-François Rossi^1,10  Timothy C Hardman^1,11 

[1] State-Funded Healthcare Institution ‘Emergency Hospital’ of Ministry of Health of Chuvash Republic;Grodno State Medical University;State-Funded Healthcare Institution ‘Infectious Disease Hospital No. 3’ of Ministry of Health of Krasnodar Krai;State-Funded Institution of Mari El Republic ‘Ioshkar-Ola City Hospital’;State Budgetary Institution of Health of the Samara Region ‘Samara City Hospital No. 6’;Federal State Budgetary Institution ‘National Medical and Surgical Center named after N.I. Pirogov’ of the Ministry of Healthcare of the Russian Federation;State-Funded Healthcare Institution of Voronezh Region ‘Novaya Usman District Hospital’;NPO Petrovax Pharm LLC;IDEA Regulatory;Institut Sainte Catherine, 84918 Avignon, France and Université de Montpellier;Niche Science & Technology Ltd

关键词: azoximer bromide;    clinical improvement;    COVID-19;    exploratory research;    Polyoxidonium®;   

DOI  :  10.7573/dic.2022-1-1

学科分类：社会科学、人文和艺术（综合）

来源: C S F Medical Communications Ltd.

【 摘 要 】

Background: Evidence-based therapies used to treat coronavirus disease (COVID-19) remain limited. Azoximer bromide (AZB; Polyoxidonium®) is an immunomodulating molecule frequently used in the Russian Federation. It offers demonstrable therapeutic benefit in upper respiratory tract infections. This study evaluated the safety and efficacy of AZB when used in combination with standard of care treatment in patients hospitalized with COVID-19. Methods: Hospitalized patients with COVID-19 (n=81; nine sites) received AZB 12 mg intravenously once daily for 3 days then intramuscularly every other day until day 17. The primary endpoint included clinical status at day 15 versus baseline. Historical control data of 100 patients from a randomized, controlled, open-label trial conducted in China were included to serve as a direct control group. Results: Notable clinical improvement, assessed by seven-point ordinal scale (OS) score and National Early Warning Score, was observed. Mean duration of hospitalization was 19.3 days. Indicators of pneumonia and lung function showed gradual recovery to normalization. No patients died but, by day 28, one patient still required respiratory support; this patient died on day 34. A higher proportion of patients receiving AZB required invasive or non-invasive ventilation (OS 5 or 6) at baseline compared with the historical control group. Improvement in mean OS score by day 14/15 was not notable in the control group (OS 3.99–3.87) but was clear in the AZB group (OS 4.36–2.90). Mean duration of hospitalization was similar in the control group (16.0 days); however, day 28 mortality was higher, at 25.0% (n=25). Conclusion: AZB combined with standard of care was safe and well tolerated. An apparent clinical improvement could not be fully evaluated due to the lack of a direct control group; further assessment of AZB for the treatment of COVID-19 in a randomized, placebo-controlled study is warranted.

【 授权许可】

CC BY-NC-ND