ABSTRACT
Remdesivir (GS-5734) is a new direct-acting antiviral drug in the nucleotide analogue class with antiviral activity against SARS-CoV-2 and the ability to inhibit RNA-dependent RNA polymerase. Preliminary results from phase III randomized clinical trials of remdesivir are inconsistent. Understanding the fact of the limited world experience with the use of remdesivir in COVID-19 required further study of its efficacy and safety in real clinical practice. The aim of the study is to evaluate the efficacy and safety of remdesivir in the treatment of patients with COVID-19. Material and methods. The study included 1422 patients with a novel coronavirus infection (COVID-19) who received remdesivir as part of complex therapy in a hospital setting at medical organizations of the Moscow public health system. Additionally, standard therapy was carried out, regulated by the Interim Guidelines "Prevention, Diagnosis and Treatment of Novel Coronavirus Infection (COVID-19)" of the Ministry of Healthcare of the Russian Federation, the current version. The efficacy of the drug was assessed based on primary and secondary efficacy points. Primary variable: 1) cumulative incidence of clinical outcomes in patients with COVID-19 treated with remdesivir as part of complex therapy;2) median time to clinical improvement according to the World Health Organization ordinal categorical scale (under clinical improvement, the patient is assumed to move >2 categories towards improvement in clinical condition). Secondary variables: 1) median time to achieve <2 NEWS scores lasting at least 24 hours or hospital discharge;2) mortality from all causes;3) duration of fever (>38 degreeC), days;4) duration of hospitalization, days;5) time to achieve elimination of the pathogen from the upper respiratory tract (no SARS-CoV-2 RNA), days. The safety of remdesivir was assessed based on the registration of adverse events using the method of spontaneous reports. Results. The analysis of clinical outcomes of treatment showed that 1195 (84.1%) patients recovered, death from all causes occurred in 227 (15.9%) patients. The median improvement in clinical status on the World Health Organization ordinal categorical scale was 6 days. The median time to reach a NEWS score of <2, lasting at least 24 hours, or hospital discharge was 4 days. The median duration of fever was 3 days from the start of remdesivir administration. The median length of hospital stays for patients included in the Register was 9 days. Adverse reactions associated with the use of remdesivir were recorded in 11 (0.7%) patients. Serious adverse reactions were not registered. During hospitalization, all adverse reactions were resolved. Conclusion. A retrospective analysis of data from the Registry of 1422 patients with COVID-19 who received remdesivir as part of complex therapy in medical organizations of the state healthcare system of Moscow in routine clinical practice showed clinical efficacy and a favorable safety profile of remdesivir (Remdeform, lyophilizate for solution for intravenous administration 100 mg, manufactured by JSC Pharmasyntez, Russia). The data obtained are consistent with previous randomized clinical trials of remdesivir and allow us to recommend its further use in patients with COVID-19 as part of complex therapy.Copyright © The Author(s), 2022.
ABSTRACT
Objective. assessment of the evolution of the microbiological landscape of the hospital for the period of operation in 2020 into a pandemic of a new coronavirus infection in various departments, including intensive care units;change depending on the results of antibacterial therapy regimens. Materials and methods. In a retrospective study, conducted from June to December 2020, in a multidisciplinary hospital working with COVID-19 infection, the resistance of isolated strains of microorganisms was analyzed in patients of different age groups. Resistance was assessed with test points in June and November 2020;depending on this, proposals were made to correct the internal (local) protocols of antimicrobial therapy. Results. The need for frequent and regular microbiological monitoring was confirmed. Further, we understood that the territories of the main and temporary hospital of the City Clinical Hospital No. 40 are heterogeneous and there are obvious differences both in structure and in the level of sensitivity. "In practice, these are two different hospitals". Within the territories, the branches also differ from each other. When analyzing resistance in ICUs, it was revealed that within each hospital in each department, albeit similar in structure and profile of patients, there is a different level of resistance of strains. Conclusions. The structure of sensitivity generally corresponds to the world data, but for some pathogens it differs significantly. Microbiological monitoring should be carried out not only inside the hospital, but also inside the department. The increase in consumption of carbapenems and protected cephalosporins requires a reassessment of the practice of using AMP in any covid hospital, due to the impact on the epidemic situation both in the ICUs and in the hospital.Copyright © 2021, Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy. All rights reserved.
ABSTRACT
Remdesivir (GS-5734) is a new direct-acting antiviral drug in the nucleotide analogue class with antiviral activity against SARS-CoV-2 and the ability to inhibit RNA-dependent RNA polymerase. Preliminary results from phase III randomized clinical trials of remdesivir are inconsistent. Understanding the fact of the limited world experience with the use of remdesivir in COVID-19 required further study of its efficacy and safety in real clinical practice. The aim of the study is to evaluate the efficacy and safety of remdesivir in the treatment of patients with COVID-19. Material and methods. The study included 1422 patients with a novel coronavirus infection (COVID-19) who received remdesivir as part of complex therapy in a hospital setting at medical organizations of the Moscow public health system. Additionally, standard therapy was carried out, regulated by the Interim Guidelines “Prevention, Diagnosis and Treatment of Novel Coronavirus Infection (COVID-19)” of the Ministry of Healthcare of the Russian Federation, the current version. The efficacy of the drug was assessed based on primary and secondary efficacy points. Primary variable: 1) cumulative incidence of clinical outcomes in patients with COVID-19 treated with remdesivir as part of complex therapy;2) median time to clinical improvement according to the World Health Organization ordinal categorical scale (under clinical improvement, the patient is assumed to move >2 categories towards improvement in clinical condition). Secondary variables: 1) median time to achieve <2 NEWS scores lasting at least 24 hours or hospital discharge;2) mortality from all causes;3) duration of fever (>38 °C), days;4) duration of hospitalization, days;5) time to achieve elimination of the pathogen from the upper respiratory tract (no SARS-CoV-2 RNA), days. The safety of remdesivir was assessed based on the registration of adverse events using the method of spontaneous reports. Results. The analysis of clinical outcomes of treatment showed that 1195 (84.1%) patients recovered, death from all causes occurred in 227 (15.9%) patients. The median improvement in clinical status on the World Health Organization ordinal categorical scale was 6 days. The median time to reach a NEWS score of <2, lasting at least 24 hours, or hospital discharge was 4 days. The median duration of fever was 3 days from the start of remdesivir administration. The median length of hospital stays for patients included in the Register was 9 days. Adverse reactions associated with the use of remdesivir were recorded in 11 (0.7%) patients. Serious adverse reactions were not registered. During hospitalization, all adverse reactions were resolved. Conclusion. A retrospective analysis of data from the Registry of 1422 patients with COVID-19 who received remdesivir as part of complex therapy in medical organizations of the state healthcare system of Moscow in routine clinical practice showed clinical efficacy and a favorable safety profile of remdesivir (Remdeform®, lyophilizate for solution for intravenous administration 100 mg, manufactured by JSC Pharmasyntez, Russia). The data obtained are consistent with previous randomized clinical trials of remdesivir and allow us to recommend its further use in patients with COVID-19 as part of complex therapy. © The Author(s), 2022.
ABSTRACT
Objective. assessment of the evolution of the microbiological landscape of the hospital for the period of operation in 2020 into a pandemic of a new coronavirus infection in various departments, including intensive care units;change depending on the results of antibacterial therapy regimens. Materials and methods. In a retrospective study, conducted from June to December 2020, in a multidisciplinary hospital working with COVID-19 infection, the resistance of isolated strains of microorganisms was analyzed in patients of different age groups. Resistance was assessed with test points in June and November 2020;depending on this, proposals were made to correct the internal (local) protocols of antimicrobial therapy. Results. The need for frequent and regular microbiological monitoring was confirmed. Further, we understood that the territories of the main and temporary hospital of the City Clinical Hospital No. 40 are heterogeneous and there are obvious differences both in structure and in the level of sensitivity. “In practice, these are two different hospitals”. Within the territories, the branches also differ from each other. When analyzing resistance in ICUs, it was revealed that within each hospital in each department, albeit similar in structure and profile of patients, there is a different level of resistance of strains. Conclusions. The structure of sensitivity generally corresponds to the world data, but for some pathogens it differs significantly. Microbiological monitoring should be carried out not only inside the hospital, but also inside the department. The increase in consumption of carbapenems and protected cephalosporins requires a reassessment of the practice of using AMP in any covid hospital, due to the impact on the epidemic situation both in the ICUs and in the hospital. © 2021, Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy. All rights reserved.