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1.
Pharmacy & Pharmacology-Farmatsiya I Farmakologiya ; 11(1):72-88, 2023.
Article in English | Web of Science | ID: covidwho-20232876

ABSTRACT

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 (RADAM IN (R) 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 RADAM IN (R) 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 drug 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 [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 drug 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 drug 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.

2.
Infectious Diseases: News, Opinions, Training ; 10(3):106-117, 2021.
Article in Russian | EMBASE | ID: covidwho-2325705

ABSTRACT

The purpose of this review is to analyze the data of scientific articles on medicines indicated as etiotropic and approved for outpatient use within the framework of temporary methodological recommendations for the prevention, diagnosis and treatment of a new coronavirus infection in the Russian Federation. Material and methods. A systematic search of literature was carried out on the databases MEDLINE, PubMed, Cochrane Library, GHL, OpenGrey, ICTRP and ClinicalTrials.gov until April 2021. 37 779 articles were indexed in the ScienceDirect database (keywords: SARS-CoV-2), of which (pre-press) - 2023 (2), 2022 (69), published in 2021 (19 642 articles), in 2020 (12,966 articles). The search was carried out using the following keywords: Favipiravir - 1622 publications, Umifenovir - 387 publications, which indicates a high interest in the problem of new coronavirus infection in general and its drug (etiotropic) therapy, in particular. Results. The conducted analysis demonstrates that drugs based on favipiravir have a larger number of studies proving its effectiveness in different clinical groups of patients with COVID-19, while it is important to note the breadth of the geography of published works, which allows us to speak about the reproducibility of the results. Drugs from this group have a direct antiviral effect with the studied target of action (i.e., most likely, the principle of etiotropic therapy is implemented). Conclusion. The search for new drugs, as well as the expansion of information about the mechanisms of action of previously known molecules, is the basis for the development of COVID-19 therapy regimens with maximum efficiency and safety.Copyright © 2021 Sovero Press Publishing House. All rights reserved.

3.
Farmatsiya i Farmakologiya ; 10(6):573-588, 2022.
Article in English | EMBASE | ID: covidwho-2251079

ABSTRACT

Currently, there are data that that make it possible to speak about a high clinical efficacy of the use of succinic salt of tyrosylD-alanyl-glycyl-phenylalanyl-leucyl-arginine (hexapeptide succinate) for the COVID-19 treatment. This article is devoted to the results of clinical trials of the original Russian drug based on it. The aim of the study was to evaluate a clinical efficacy, safety and tolerability of intramuscular and inhalation use of hexapeptide succinate in complex therapy in comparison with standard therapy in patients with moderate COVID-19. Materials and methods. The research was conducted from February 28, 2022 to November 22, 2022 based on 10 research centers in the Russian Federation. The study included hospitalized patients (n=312) over 18 years of age with moderate COVID-19 who had undergone a screening procedure and were randomized into 3 groups: group 1 received standard therapy in accordance with the Interim Guidelines in force at the time of the study, within 10 days;group 2 received hexapeptide succinate (Ambervin Pulmo) intramuscularly at the dose of 1 mg once a day for 10 days;group 3 received hexapeptide succinate (Ambervin Pulmo) 10 mg once a day by inhalation for 10 days. Results. According to the results of the study, therapy with the drug hexapeptide succinate, both intramuscular and inhaled, provided an acceleration of recovery up to the complete absence of the disease signs in more than 80% of hospitalized COVID-19 patients. By the end of the therapy course with the drug, more than 60% of patients had met the criteria for discharge from hospital and could continue the treatment on an outpatient basis. About 70% of patients in the inhalation group and 80% in the intramuscular hexapeptide succinate injection group had concomitant diseases (hypertension - 28%, obesity - 14%), which indicates the effectiveness of this drug use in comorbid patients. The use of the drug contributed to the restoration of damaged lung tissues, normalization of oxygenation, the disappearance of shortness of breath and a decrease in the duration of the disease symptoms compared with standard therapy. As a result of a comparative analysis of adverse events in terms of their presence, severity, causal relationship with the therapy and outcome, there were no statistically significant differences between the treatment groups. Conclusion. Thus, the results of the clinical study of the succinate hexapeptide efficacy and safety showed the feasibility of using the drug in pathogenetic therapy COVID-19 regimens.Copyright © 2022 Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute. All rights reserved.

4.
Pharmacy & Pharmacology-Farmatsiya I Farmakologiya ; 10(5):432-445, 2022.
Article in English | Web of Science | ID: covidwho-2237446

ABSTRACT

Since the beginning of the pandemic, repeated attempts have been made to develop etiotropic therapy for a novel coronavirus infection. Hydroxychloroquine, lopinavir/ritonavir, etc. derivatives were used as antiviral agents, however, they demonstrated a low efficiency and an insufficient safety. In this connection, other groups of drugs with a more effective and safe pharmacological profile are currently being actively used. The aim of the study was to analyze the literature references on the efficacy and safety of antiviral drugs for the COVID-19 treatment.Materials and methods. When searching for the materials for the review article writing, such databases as PubMed, Google Scholar, e-Library were used. The search was carried out on publications for the period from January 2020 to September 2022. The key queries were: COVID-19, etiotropic therapy;immunological drugs;antiviral drugs;interferons.Results. Currently, there are various degrees of effective etiotropic drugs for the treatment of COVID-19 patients. The review has considered a few groups of drugs that are of interest from the point of view of etiotropic therapy: immunological drugs (anticovid plasma, the drugs based on antiviral antibodies, the drugs of recombinant interferons-alpha 2 and-beta 1, as well as interferon inducers, i.e., the drugs based on double-stranded RNA sodium salt, and others);drugs that block the penetration of the virus into the cell (umifenovir);the drugs that disrupt the process of the viral replication (favipiravir, remdesivir, molnupiravir, nirmatrelvir/ritonavir).Conclusion. Synthetic antivirals, in particular favipiravir, molnupiravir, remdesivir, and nirmatrelvir/ritonavir, have the largest evidence base for their efficacy and safety. The search for new effective and safe etiotropic drugs for the treatment of COVID-19, as well as the collection and analysis of post-registration data on the drugs already used in clinical practice, continues.

5.
Farmatsiya i Farmakologiya ; 10(5):432-445, 2022.
Article in English | EMBASE | ID: covidwho-2217824

ABSTRACT

Since the beginning of the pandemic, repeated attempts have been made to develop etiotropic therapy for a novel coronavirus infection. Hydroxychloroquine, lopinavir/ritonavir, etc. derivatives were used as antiviral agents, however, they demonstrated a low efficiency and an insufficient safety. In this connection, other groups of drugs with a more effective and safe pharmacological profile are currently being actively used. The aim of the study was to analyze the literature references on the efficacy and safety of antiviral drugs for the COVID-19 treatment. Materials and methods. When searching for the materials for the review article writing, such databases as PubMed, Google Scholar, e-Library were used. The search was carried out on publications for the period from January 2020 to September 2022. The key queries were: COVID-19, etiotropic therapy;immunological drugs;antiviral drugs;interferons. Results. Currently, there are various degrees of effective etiotropic drugs for the treatment of COVID-19 patients. The review has considered a few groups of drugs that are of interest from the point of view of etiotropic therapy: immunological drugs (anticovid plasma, the drugs based on antiviral antibodies, the drugs of recombinant interferons-alpha2 and -beta1, as well as interferon inducers, i.e., the drugs based on double-stranded RNA sodium salt, and others);drugs that block the penetration of the virus into the cell (umifenovir);the drugs that disrupt the process of the viral replication (favipiravir, remdesivir, molnupiravir, nirmatrelvir/ritonavir). Conclusion. Synthetic antivirals, in particular favipiravir, molnupiravir, remdesivir, and nirmatrelvir/ritonavir, have the largest evidence base for their efficacy and safety. The search for new effective and safe etiotropic drugs for the treatment of COVID-19, as well as the collection and analysis of post-registration data on the drugs already used in clinical practice, continues. Copyright © 2022 Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute. All rights reserved.

6.
Farmatsiya i Farmakologiya ; 10(2):217-228, 2022.
Article in English | Scopus | ID: covidwho-1912455

ABSTRACT

The article presents modern scientific data on long-term clinical and pathogenetic effects of the antiviral drug Areplivir (Favipiravir) in patients with metabolic syndrome in the post-COVID period. The aim of the article is to study long-term cytokine-mediated (IL-6/sIL6r and LIF/sLIFr) pathogenetic effects of the favipiravir (Areplivir®) based drug on the incidence of complications in patients with metabolic syndrome in the post-COVID period. Material and methods. With the approval of the local ethics committee at the N.P. Ogarevs Mordovia State University (Protocol No. 5 dated May 17, 2020) “An open prospective comparative study of the Areplivir® (Favipiravir) drug effectiveness in reducing the risk of complications in the post-COVID period in patients with metabolic syndrome” in the Republic of Mordovia was carried out. The study included 190 metabolic syndrome patients who received the outpatient treatment for COVID-19 at Saransk polyclinics from February 2021 to March 2021. The case of COVID-19 was diagnosed in accordance with the current Temporary Guidelines for the prevention, diagnosis and treatment of the new coronavirus infection. Results. The analysis of the metabolic syndrome patients' follow-up within 1 year after undergoing COVID-19, revealed significant differences in the incidence of complications depending on the intake of the favipiravir based drug. The patients who were administrated with favipiravir at the early stage of infection, were characterized by lower serum levels of four members of the interleukin 6 family - IL-6 (IL-6, sIL6r and LIF, sLIFr) 10, 30 and 180 days after a clinical and laboratory recovery (p<0.001). The average statistical changes in the IL-6/sIL6r system of the group administrated with favipiravir, were 90%, and they were higher than in the group not administrated with antiviral drugs. In the group of the patients administrated with favipiravir, there was a significant (p<0.001) positive dynamic of the sLIFr indicator, while in the comparison group, there was an increase in this indicator. A protective effect of the early favipiravir use was characterized by a decrease in the frequency of cardiovascular complications, a 2.66-fold decrease in the risk of a stroke and the ACS in the post-COVID period. Conclusion. The areplivir therapy in the acute period of coronavirus infection made it possible to timely reduce the viral load. It helps to correct the pro-inflammatory vector of the immune response at the post-COVID stage and, accordingly, reduces the risk of progression of atherosclerosis, transient cerebrovascular accidents with a cognitive decline, an endothelial dysfunction, and can be considered a secondary prevention of life-threatening cardiovascular complications. © 2022 Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute. All rights reserved.

7.
Bull Exp Biol Med ; 173(1): 46-50, 2022 May.
Article in English | MEDLINE | ID: covidwho-1872572

ABSTRACT

Morphological and functional characteristics of erythrocytes, hemoglobin, and erythropoietin level in the venous blood were evaluated by laser interference microscopy, Raman spectroscopy with a short-focus extreme aperture lens monochromator, and by ELISA, respectively, in 30 patients with verified moderate COVID-19 at the time of hospitalization and 30 healthy volunteers. The patients whose course of COVID-19 has worsened to critical by day 5 had already had lower (p<0.001) indicators at the time of hospitalization such as the area and thickness of erythrocytes, the hemoglobin distribution and packing density, hemoglobin conformation index (I1355/I1550)/(I1375/I1580) reflecting its oxygen affinity, and blood erythropoietin content. Our findings suggest that these characteristics of erythrocytes, hemoglobin, and erythropoietin can serve as potential predictors of COVID-19 aggravation in hospitalized patients.


Subject(s)
COVID-19 , Erythropoietin , Erythrocytes/chemistry , Hemoglobins/chemistry , Humans
8.
Pharmacy & Pharmacology-Farmatsiya I Farmakologiya ; 9(6):454-464, 2021.
Article in English | Web of Science | ID: covidwho-1579555

ABSTRACT

In many ways, arterial hypertension and obesity determine the likelihood of a severe course and lethal outcomes in COVID-19. This fact justifies the expediency of an early use of drugs with a direct antiviral action, the analysis of their efficacy not only in the acute, but also in the postcovid period. The aim of the research was to analyze the outpatient cards and case histories of the COVID-19 patients to study the effect of the early (up to the 5th day after the onset of the first symptoms of the disease) use of the drug based on favipiravir, on the frequency of patients' hospitalizations with arterial hypertension and obesity, as well as to determine the cytokine status characteristics of this patient category in the postcovid period. Materials and methods. "An open prospective comparative study of the "Areplivie" (favipiravir) efficacy in the debut of COVID-19 in comorbid patients" was carried out in the Republic of Mordovia (the analysis of the hospitalizations frequency and blood levels of M-CSF, EPO in 218 patients, in terms of the use of the antiviral preparation). Results. According to the results of the analysis, it was found out that, despite the presence of comorbid conditions that increase the risk of developing a severe course of COVID-19, i.e. obesity and essential arterial hypertension, in the group of patients taking favipiravir, the need for hospitalization was twice as low (p < 0.05), in relation to the comparison group. The analysis of the cytokine status revealed that in the postcovid period, in the group that took the drug based on favipiravir at the outpatient stage, the average level of M-CSF was significantly lower (p> 0.05), and EPO was higher (p> 0.05) than in the patients from the group "without antiviral drugs at the outpatient stage". Indirectly, according to the previously obtained data, that acts as a potential marker for reducing the risk of long-term cardiovascular complications of COVID-19. Conclusion. This study showed that an early prescription of favipiravir contributes to a decrease in the rate of COVID-19 patients' hospitalization even against the background of concomitant hypertension and obesity, due to a decrease in the likelihood of moderate and severe courses of the disease, and also leads to an earlier objective and subjective recovery. The results demonstrated a high potential benefit of an early favipiravir use in the novel coronavirus infection and in the prevention of postcovid complications.

9.
Infectious Diseases: News, Opinions, Training ; 10(3):106-117, 2021.
Article in Russian | Scopus | ID: covidwho-1498410

ABSTRACT

The purpose of this review is to analyze the data of scientific articles on medicines indicated as etiotropic and approved for outpatient use within the framework of temporary methodological recommendations for the prevention, diagnosis and treatment of a new coronavirus infection in the Russian Federation. Material and methods. A systematic search of literature was carried out on the databases MEDLINE, PubMed, Cochrane Library, GHL, OpenGrey, ICTRP and ClinicalTrials.gov until April 2021. 37 779 articles were indexed in the ScienceDirect database (keywords: SARS-CoV-2), of which (pre-press) – 2023 (2), 2022 (69), published in 2021 (19 642 articles), in 2020 (12,966 articles). The search was carried out using the following keywords: Favipiravir – 1622 publications, Umifenovir – 387 publications, which indicates a high interest in the problem of new coronavirus infection in general and its drug (etiotropic) therapy, in particular. Results. The conducted analysis demonstrates that drugs based on favipiravir have a larger number of studies proving its effectiveness in different clinical groups of patients with COVID-19, while it is important to note the breadth of the geography of published works, which allows us to speak about the reproducibility of the results. Drugs from this group have a direct antiviral effect with the studied target of action (i.e., most likely, the principle of etiotropic therapy is implemented). Conclusion. The search for new drugs, as well as the expansion of information about the mechanisms of action of previously known molecules, is the basis for the development of COVID-19 therapy regimens with maximum efficiency and safety. © 2021 Sovero Press Publishing House. All rights reserved.

10.
Bulletin of Russian State Medical University ; - (3):23-28, 2021.
Article in English | Web of Science | ID: covidwho-1326111

ABSTRACT

Pathogenetic progression mechanisms in the SARS-CoV-2-essential hypertension (EAH) system are more complex than interaction at the level of angiotensin-converting enzyme 2 (ACE2). The study was aimed to assess the dynamic changes of the IL1 members (IL1 beta, IL1 alpha, IL1ra, IL18, IL18BP, IL37) blood levels in patients with EAH 10, 30, and 180 days after having COVID-19 in order to define cytokine-mediated mechanisms of EAH progression during the period following infection. The study involved four groups of patients: with a history of EAH and COVID-19 (pneumonia/no pneumonia), with a history of COVID-19 (pneumonia/no pneumonia) and no EAH. Cytokine levels were determined by enzyme immunoassay. The study results demonstrate the prolonged proinflammatory immune response during the period following infection in patients with EAH (retaining higher levels of IL1 beta, IL1 alpha, and IL18 on days 10, 30, and 180 after recovery (rho < 0.001) compared to levels measured prior to SARS-CoV-2 infection). In the group with no EAH, the balance of assayed cytokines was restored on day 30 of follow-up. The two-fold increase of blood IL18 levels in patients, having a history of EAH and COVID-19 and showing no increase in the IL18BP levels after 30 days of follow up compared to the values measured prior to infection, is associated with cardiovascular complications occurring during the first six months of follow-up. This makes it possible to hypothesize the importance of these immunoregulatory peptides for the pathogenesis of complications and enhances the relevance of further scientific research.

11.
Rossiiskii immunologicheskii zhurnal ; 23(4):429-436, 2020.
Article in Russian | Russian Science Citation Index | ID: covidwho-1094898

ABSTRACT

Understanding changes in the cytokine-mediated mechanisms in immunopathogenesis of essential hypertension (EH) after COVID-19 poses a pressing scientific issue. SARS-CoV-2 exerts direct effects on macrophages with high probability altering regulatory M-CSF-VEGF-A-IL-34 axis, thereby accounting for change in cytokine-mediated patterns of hypertension progression. Immunopathogenesis of complications after SARS-CoV-2 infection and a role of M-CSF in EH pathogenesis justify study objective - to compare the serum M-CSF and VEGF-A, IL-34 levels in stage II EH patients prior to COVID-19 and one month after recovery to assess modality of altered M-CSF-mediated mechanisms behind hypertension progression. Four groups of patients were stratified depending on EH and clinical characteristics of COVID-19 (without/with pneumonia). Blood sampling was performed one month after COVID-19. The serum M-CSF and VEGF-A, IL-34 level was measured by using enzyme-linked immunosorbent assay. The data were statistically processed by using Stat Soft Statistica 13.5. Comparative analysis of serum M-CSF level in patients with stage II EH prior and after COVID-19 revealed that regardless of clinical course (with/without pneumonia) they were featured with higher levels of M-CSF one month after recovery (p < 0.001) vs baseline level. The serum VEGF-A level in patients with stage II EH did not change in papallel with increased M-CSF (458 pg/ml or more) one month after SARS CoV 2 infection. However, M-CSF stimulated rise in serum VEGF-A level and accounted for formation of marked coronary collateral network prior to infection. A relationship between the increased serum M-CSF level (higher than 392 pg/ml) and elevated percentage of COVID-19 with pneumonia in patients with stage II EH prior to the infection might be related to the hypothesis about “a role of dysregulated activation of mononuclear phagocytes in development of lung tissue damage”. The data presented prove scientific and clinical value of assessing a role for M-CSF with respect to altered cytokine-mediated patterns of EH progression after COVID-19 recovery. Понимание изменения цитокин-опосредованных звеньев иммунопатогенеза ЭАГ после перенесенного COVID-19 является актуальным научным вопросом. SARS-CoV-2 обладает прямыми эффектами действия на макрофаги, что с высокой вероятностью вносит изменения в регуляторную систему M-CSF-VEGF-A-IL-34 у данной категории больных, а значит, определяет изменение цитокин-опосредованных схем прогрессирования гипертензии. Современное состояние исследования в области иммунопатогенеза осложнений SARS-CoV-2 инфицирования и собственные данные о роли M-CSF в патогенезе ЭАГ обосновывают цель исследования - сопоставить уровни M-CSF и VEGF-A, IL-34 в сыворотке крови больных ЭАГ II стадии до и через 1 месяц после перенесенного COVID-19 для оценки характера изменения M-CSF-опосредованных механизмов прогрессирования гипертензии. Для достижения поставленной цели было сформировано 4 группы пациентов в зависимости от наличия ЭАГ и формы COVID-19 (без пневмонии и с пневмонией). Забор крови проводился через 1 месяц после перенесенного COVID-19. Содержание M-CSF и VEGF-A, IL-34 определяли иммуноферментным методом в сыворотке крови. Статистическая обработка полученных данных проводилась с помощью Stat Soft Statistica 13.5. Сравнительный анализ содержания M-CSF в сыворотке крови больных ЭАГ II стадии до и после перенесенного COVID-19 определил, что, вне зависимости от формы заболевания (ОРВИ (без пневмонии) или с пневмонией), регистрируются более высокие уровни M-CSF через 1 месяц после выздоровления (р < 0,001). При этом у больных ЭАГ II стадии через 1 месяц после SARSCoV2 инфицирования отсутствует компенсаторное увеличение VEGF-A в сыворотке крови на фоне значительного роста M-CSF (выше 458 пг/мл), что было зарегистрировано в период до инфекционного заболевания у данной категории пациентов и определяло формирование более выраженной коронарной коллатеральной сети при сравнении лиц с гемодинамически значимым изменением коронарных сосудов. Выявленная в нашем исследовании ассоциация повышенного содержания M-CSF (более 392 пг/мл) в прединфекционном периоде у больных ЭАГ II стадии и увеличением процента развития COVID-19 с пневмоний, возможно, связана с гипотезой о роли дисрегулированной активации компартмента мононуклеарных фагоцитов при развитии поражения ткани легкого. Приведенные результаты доказывают научную и клиническую ценность изучения роли M-CSF в аспекте изменение цитокинопосредованных схем прогрессирования ЭАГ после перенесенного COVID-19.

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