新冠病毒暴露后预防:双链钠盐RNA药物疗效和安全性的双盲、安慰剂对照、多中心临床研究结果

L. Balykova, O. Radaeva, K. Zaslavskaya, A. V. Taganov, P. A. Bely, K. Zakharov, V. Popova, T. Chudinovskikh, S. V. Teplykh, I. V. Balaban, R. S. Kozlov, N. V. Kirichenko, E. Simakina, K. N. Koryanova, D. Pushkar
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引用次数: 2

摘要

该研究的目的是评估RNA双链钠盐药物的有效性和安全性,该药物是用于肌肉注射和皮下给药的溶液制备的冻干液,与安慰剂相比,可作为暴露后预防COVID-19的手段。材料和方法。一项双盲、安慰剂对照、多中心、随机III期临床试验旨在评估一种双链钠盐RNA药物(RADAMIN®VIRO)的有效性和安全性。RADAMIN®VIRO是一种冻干液,用于制备肌肉注射和皮下注射溶液,作为COVID-19暴露后预防手段。这项研究于2022年5月31日至2023年1月17日在俄罗斯联邦的10个研究中心进行。该研究纳入了年龄≥18岁的男性和女性,他们与有COVID-19诊断记录且没有COVID-19特征症状的人同居。在随机化阶段,受试者被分为两组:第一组(n=400)接受研究药物RADAMIN®VIRO 5 mg(1瓶),每天一次肌肉注射;组2 (n=400)给予安慰剂1小瓶,每天肌注1次。每名受试者的研究总持续时间不超过30天。到第10-11天,双链钠盐RNA制备组确诊COVID-19且至少有1种COVID-19症状特征的比例为5.76%(23/399),安慰剂组为-11。03%(44/399)。研究药物组与安慰剂组的比例差异为0.0526(5.26%),组间比例差异的95%可信区间(CI)为-95% CI[0.0123;0.0937])。在11天的随访期间,超过94%的单剂量受试者没有感染COVID-19并出现任何症状。对比分析结果显示,研究药物组感染频次较对照组低(近2倍),具有统计学意义,说明双链钠盐RNA制剂作为暴露后预防新冠肺炎的手段具有较高的效率和方便性。因此,无论疫苗接种情况如何,使用研究双链钠盐RNA制剂作为暴露后COVID-19预防手段的有效性和可行性不仅在医疗机构(门诊诊所和医院)中得到了证明,而且在护理人员和/或与COVID-19患者接触的人员中也得到了证明。在出现大规模感染威胁和有适当医务人员的情况下,各组织和企业的情况也是如此。
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Post-exposure prophylaxis of COVID-19: results of double-blind, placebo-controlled, multicenter clinical study evaluation of efficacy and safety of double-stranded sodium salt RNA drug
The aim of the study was to evaluate the efficacy and safety of an RNA double-stranded sodium salt drug, a lyophilisate for a solution preparation for an intramuscular and subcutaneous administration, as a means of post-exposure COVID-19 prophylaxis in comparison with placebo.Material and methods. A double-blind, placebo-controlled, multicenter, randomized phase III clinical trial was conducted to evaluate the efficacy and safety of a double-stranded sodium salt RNA drug (RADAMIN®VIRO), a lyophilisate for preparing a solution for intramuscular and subcutaneous administration as a means of post-exposure prophylaxis of COVID-19. The study was conducted in 10 research centers in the Russian Federation from May 31, 2022 to January 17, 2023. The study included men and women aged ≥18 years who cohabitate with a person with a documented COVID-19 diagnosis and do not have symptoms characteristic of COVID-19. At the randomization stage, the subjects were assigned to one of two groups: group 1 (n=400) received a study drug RADAMIN®VIRO 5 mg (1 vial) intramuscularly once a day; group 2 (n=400) received placebo 1 vial intramuscularly once a day. The total duration of the study for each subject was no more than 30 days.Results. By day 10-11, in the double-stranded sodium salt RNA preparation group, the proportion of the subjects with confirmed COVID-19 and at least 1 symptom characteristic of COVID-19 was 5.76% (23/399), and in the placebo group – 11. 03% (44/399). The difference in proportions between the study drug and placebo groups was 0.0526 (5.26%), the 95% confidence interval (CI) for the difference in proportions between the groups was -95% CI [0.0123;0.0937]). More than 94% of single-dose subjects did not become infected with COVID-19 with any symptoms during the 11 days of the follow-up. As a result of a comparative analysis, it was shown that the infection frequency in the study drug group was statistically significantly (almost twice) less than in the comparison group, which indicates a high efficiency and expediency of using the double-stranded sodium salt RNA preparation as a means of the post-exposure COVID-19 prophylaxis.Conclusion. Thus, regardless of the vaccination availability, the effectiveness and feasibility of using the study double-stranded sodium salt RNA preparation as a means of the post-exposure COVID-19 prophylaxis was demonstrated not only in medical institutions (outpatient clinics and hospitals), but also in caregivers and/or the persons in contact with COVID-19 patients. The situation was the same in the organizations and enterprises in case of evolution of a mass infection threat and the availability of appropriate medical personnels.
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