ABSTRACT
Clinical parameters characterizing the efficacy and safety of favipiravir were examined in a multicenter, non-interventional (before-and-after study design) trial in 264 patients with mild COVID-19. It is shown that on the background of 14-day therapy with favipiravir body temperature normalized, blood oxygen saturation improved, and the frequency of tachycardia detection reduced by 16% (p < 0.0001). A statistically significant decrease by 91,3% (p 0.0001) in the frequency of SARS-nCoV-2 RNA detection in the nasopharyngeal mucosa discharge was revealed. A decrease in the concentration of ferritin (by 69% compared to initial values), blood glucose (by 21%), creatinine (by 10%), C-reactive protein (by 36%) (p 0.0001), and D-dimer by 61% (p = 0.016) was noted. The results of the SF-36 health survey questionnaire revealed a significant (p 0.05) improvement in the quality of life in terms of physical functioning (by 35%), and role functioning associated with physical and emotional state by 107% and 160%, respectively. Analysis of the COV19-QoL questionnaire revealed a decrease by 24% in negative perception of the disease (p < 0,01). Among the identified adverse events, elevated level of ALT (in 39.47% of patients), hyperuricemia (in 28.95% of patients), and elevated AST (in 23.68% of patients) prevailed. All the adverse events occurred with mild or moderate severity. There were no lethal outcomes in the studied sample of patients. The analysis showed a satisfactory level of the tolerability of the treatment.Copyright © 2023 Izdatel'stvo Meditsina. All rights reserved.
ABSTRACT
Clinical parameters characterizing the efficacy and safety of favipiravir were examined in a multicenter, non-interventional (before-and-after study design) trial in 264 patients with mild COVID-19. It is shown that on the background of 14-day therapy with favipiravir body temperature normalized, blood oxygen saturation improved, and the frequency of tachycardia detection reduced by 16% (p < 0.0001). A statistically significant decrease by 91,3% (p 0.0001) in the frequency of SARS-nCoV-2 RNA detection in the nasopharyngeal mucosa discharge was revealed. A decrease in the concentration of ferritin (by 69% compared to initial values), blood glucose (by 21%), creatinine (by 10%), C-reactive protein (by 36%) (p 0.0001), and D-dimer by 61% (p = 0.016) was noted. The results of the SF-36 health survey questionnaire revealed a significant (p 0.05) improvement in the quality of life in terms of physical functioning (by 35%), and role functioning associated with physical and emotional state by 107% and 160%, respectively. Analysis of the COV19-QoL questionnaire revealed a decrease by 24% in negative perception of the disease (p < 0,01). Among the identified adverse events, elevated level of ALT (in 39.47% of patients), hyperuricemia (in 28.95% of patients), and elevated AST (in 23.68% of patients) prevailed. All the adverse events occurred with mild or moderate severity. There were no lethal outcomes in the studied sample of patients. The analysis showed a satisfactory level of the tolerability of the treatment.Copyright © 2023 Izdatel'stvo Meditsina. All rights reserved.
ABSTRACT
The COVID-19 pandemic resulted in many aftermaths, economic crisis and extra charging of health care. The development of vaccine against SARS-nCoV-2 agent turned out as the priority task of world and Russian medicine and pharmaceutics. The investigation of efficiency and safety of vaccines can be prolonged for many years that can aggravate the observed crisis. Having regard to the global scope and speed of pandemic spreading, the vaccine "Gam-COVID-Vac" was registered with special procedure by the Decree of the Government of the Russian Federation No. 441 of 03.04.2020 for accelerated access to civic turn-over. To monitor safety of vaccine on the basis of international experience, the decision was made to organize the independent Committee of monitoring data concerning efficacy and safety of vaccines applied to prevent COVID-19. The article presents rationale for necessity to create independent committee and to implement such a practice.