The efficacy of medicinal products based on plasma immunoglobulins and monoclonal antibodies for the treatment and prevention of COVID-19

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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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

Балыкова

Radaeva

Zaslavskaya

et al. 2023

Farm. farmakol. (Pâtigorsk)

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Analysis of cytokine response characteristics and immunopathogenetic effects of double-stranded sodium salt RNA-based drug for postexposure prophylaxis against novel coronavirus infection: double-blind, placebo-controlled trial

Radaeva,

Balykova,

Zaslavskaya

et al. 2023

Farm. farmakol. (Pâtigorsk)

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The aim of the work was to study сytokine response characteristics in the group of persons contacted by a novel coronavirus infection depending on the development of the disease over the next 14 days. Herewith, for the immunocorrection with a preparation based on RNA double-stranded sodium salt (RADAMIN®VIRO) causing a secondary reduction in the risk of COVID-19 in the analyzed group, potential targets had been selected.Materials and methods. A double-blind, placebo-controlled study of the drug based on RNA double-stranded sodium salt therapeutic effects was conducted in a group of patients who had been in contact with the persons having a confirmed diagnosis of COVID-19. The method of enzyme immunoassay in dynamics was used to determine the content of interferons alpha and beta (IFNα and IFNβ, respectively), interleukin-1β and -10 (IL1β and IL-10, respectively) in the blood serum and saliva in the contact persons, with a retrospective assessment of changes depending on the administration of the drug or placebo, as well as the development of COVID-19.Results. In the course of the presented study, it was demonstrated that the established content of IFNα (less than 28 pg/ml) and IFNβ (less than 12 pg/ml) in saliva on the 1st–2nd contact days is a predictor of an increased risk of developing COVID-19. Herewith, the increase degree in these immunoregulatory peptides in the interval of 2–3 contact days is important: IFNα and IFNβ allows leveling the negative prognosis in patients by 250% or more. The lowest rates (p <0.001) of INFα on the 1st–2nd contact days, as well as an increase of less than 21% by the 3rd day, were observed in persons with a waist circumference of more than 80/94 cm (women/men). The incidence in this group was higher and amounted to 85% (16 out of 20 people). The predictor role of IL-1β and IL-10 in the blood and saliva in relation to the start of the infectious process was not revealed. The administration of drug based on RNA double-stranded sodium salt to the contact patients made it possible to correct the interferon response in the form of an increase in the content of IFNα and IFNβ, as well as to reduce the incidence in comparison with the placebo group.Conclusion. Differences in the interferon regulation upon contact with SARS-CoV-2 in the form of lower INF α and β levels, as well as a slightly pronounced growth dynamics in the interval of the first 3 days, influenced the increased risk of developing COVID-19. RADAMIN®VIRO can be recommended as a means of post-exposure prophylaxis of COVID-19 for both medical institutions and for caregivers and / or contacts with COVID-19 patients.

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Issues of Physicochemical Quality Assessment of Immunobiological Medicinal Products in the Context of Formation of a Regulatory System in the Eurasian Economic Union

Ustinnikova,

Shcherbachenko,

Kolesnikova

et al. 2024

BIOMEDICINE

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In this study, we consider problematic issues associated with harmonization of pharmacopoeial approaches to the assessment of the main physicochemical indicators of immunobiological medicinal products in the context of formation of a regulatory system of the Euro-Asian Economic Union (EAEU) with the purpose of ensuring the independence of the pharmaceutical market of the Russian Federation. Among the selected quality indicators of human immunoglobulin preparations, which are used in national and international pharmacopoeial standards, were selected the following: “Protein”, “Electrophoretic homogeneity”, and “Molecular parameters”. “Thiomersal”, “Phenol”, and “Aluminum” were selected to assess the quality of vaccines and anatoxins. The harmonization of the above methodological approaches to the assessment of a particular indicator is hampered by the historically evolved differences in the requirements and recommendations of the State Pharmacopoeia of the Russian Federation and the European Pharmacopoeia, recognized as the basis for the development of harmonized requirements of the EAEU pharmacopoeia. These differences relate to methodologies, standards for a particular indicator, and approaches to their metrological support (use of appropriate reference materials). In the course of the study, a comparative analysis of these differences was carried out. The tendency of most manufacturers to switch to the use of high-tech laboratory equipment based on high-performance liquid and/or gas chromatography and atomic absorption spectrometry is noted. Information on the development of these methods and the availability of appropriate reference materials is provided. The conducted comparative analysis indicates the relevance of the development and certification of pharmacopoeial reference materials for harmonized methods of determination of protein, electrophoretic homogeneity, and molecular parameters. Approaches to extending the application range of available pharmacopoeial reference materials are shown, taking into account the potential of improved methods of quality control of vaccines and anatoxins by quantitative content of preservatives and adjuvants. The Russian laboratory pharmaceutical practice is focused on the specifics of immunobiological preparations and the use of pharmacopoeial reference materials that enable intra- and inter-laboratory quality testing.

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The efficacy of medicinal products based on plasma immunoglobulins and monoclonal antibodies for the treatment and prevention of COVID-19

Cited by 3 publications

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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

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

Analysis of cytokine response characteristics and immunopathogenetic effects of double-stranded sodium salt RNA-based drug for postexposure prophylaxis against novel coronavirus infection: double-blind, placebo-controlled trial

Issues of Physicochemical Quality Assessment of Immunobiological Medicinal Products in the Context of Formation of a Regulatory System in the Eurasian Economic Union

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