Efimov Sergey V, Matsiyeuskaya Natallia V, Boytsova Olga V, Akhieva Luydmila Yu, Kuntsevich Elena V, Troshina Anastasia A, Kvasova Elena I, Tikhonov Anton A, Khomyakova Nadezhda F, Harrison Francisco, Rossi Jean-François, Hardman Timothy C
State-Funded Healthcare Institution 'Emergency Hospital' of Ministry of Health of Chuvash Republic, 428017, Chuvash Republic, Cheboksary, Moskovskiy Avenue, 47, Russian Federation.
Grodno State Medical University, 230009, Gorkogo Street, 80, Grodno, Republic of Belarus.
Drugs Context. 2022 Mar 3;11. doi: 10.7573/dic.2022-1-1. eCollection 2022.
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.
Hospitalized patients with COVID-19 (=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 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.
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% (=25).
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.
用于治疗冠状病毒病（COVID-19）的循证疗法仍然有限。阿佐昔莫溴（AZB；聚氧化铵）是俄罗斯联邦常用的一种免疫调节分子。它在上呼吸道感染中具有明显的治疗益处。本研究评估了AZB与标准治疗联合用于COVID-19住院患者时的安全性和疗效。
COVID-19住院患者（=81例；9个地点）接受静脉注射AZB 12 mg，每日1次，共3天，然后每隔一天肌肉注射，直至第17天。主要终点包括第15天（基线）的临床状态。纳入了来自中国一项随机、对照、开放标签试验的100例患者的历史对照数据，作为直接对照组。
通过七点序贯量表（OS）评分和国家早期预警评分评估，观察到显著的临床改善。平均住院时间为19.3天。肺炎和肺功能指标显示逐渐恢复正常。无患者死亡，但到第28天，有1例患者仍需要呼吸支持；该患者于第34天死亡。与历史对照组相比，接受AZB治疗的患者在基线时需要有创或无创通气（OS 5或6）的比例更高。对照组在第14/15天平均OS评分的改善不显著（OS 3.99 - 3.87），但在AZB组中很明显（OS 4.36 - 2.90）。对照组的平均住院时间相似（16.0天）；然而，第28天的死亡率更高，为25.0%（=25例）。
AZB与标准治疗联合使用是安全的，耐受性良好。由于缺乏直接对照组，无法充分评估明显的临床改善；有必要在一项随机、安慰剂对照研究中进一步评估AZB治疗COVID-19的效果。
