RESUMO
AIM: To evaluate the efficacy and safety of riamilovir in the treatment of COVID-19 in adults. MATERIALS AND METHODS: The study included 180 patients with a laboratory-confirmed diagnosis of COVID-19 which fully meet the criteria for inclusion, non-inclusion and exclusion, signed a voluntary informed consent to participate in a clinical trial. RESULTS: The efficacy, good tolerability and safety of the drug riamilovir in the treatment of COVID-19 have been established. CONCLUSION: As a result of a multicenter randomized double-blind clinical trial, the effectiveness of the drug riamilovir for therapeutic use in patients with COVID-19 according to the 1250 mg/day scheme (250 mg capsules 5 times per day) for 10 days was established. The drug riamilovir in a daily dose of 1250 mg for 10 days does not differ in safety from placebo.
Assuntos
Tratamento Farmacológico da COVID-19 , Humanos , Método Duplo-Cego , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Resultado do Tratamento , Antivirais/administração & dosagem , Antivirais/efeitos adversos , Antivirais/uso terapêutico , COVID-19 , SARS-CoV-2RESUMO
AIM: Evaluation of the efficacy and safety of riamilovir as a drug for the prevention of coronavirus infection (COVID-19) in adults who have constant contact with COVID-19 patients as a result of living together. MATERIALS AND METHODS: The study included 750 adult participants living with patients with confirmed polymerase chain reaction method COVID-19, who had a negative polymerase chain reaction result for the SARS-CoV-2 virus at the initial level, met the criteria for inclusion, non-inclusion and exclusion, and signed a voluntary informed consent to participate in a clinical trial. RESULTS: The efficacy, good tolerability and safety of the drug riamilovir for the prevention of COVID-19 infection among people who have come into contact with COVID-19 patients in a family focus of infection have been established. CONCLUSION: As a result of a multicenter randomized double-blind clinical trial, the effectiveness of the drug riamilovir for the prevention of COVID-19 infection was established. It was shown that the relative risk of disease in the group taking riamilovir for prophylaxis was 88.96% lower than in the control group. Based on the results of a clinical trial, in October 2023 Ministry of Health of the Russian Federation approved the inclusion of a new indication (prophylaxis of COVID-19 infection) in the instructions for the medical use of the drug riamilovir (trade name - Triazavirin®).
Assuntos
Tratamento Farmacológico da COVID-19 , COVID-19 , Humanos , Método Duplo-Cego , Masculino , Feminino , Adulto , COVID-19/prevenção & controle , COVID-19/epidemiologia , Pessoa de Meia-Idade , Antivirais/administração & dosagem , Antivirais/uso terapêutico , SARS-CoV-2 , Resultado do Tratamento , Federação RussaRESUMO
AIM: Confirmation of the efficacy and safety of the drug riamilovir (Triazavirin®), 100 mg capsules, in children aged 12-17 years with the diagnosis of acute viral respiratory infection (ARVI). MATERIALS AND METHODS: The multicenter study included 269 patients diagnosed with acute viral respiratory infection (ICD-10 code: J00, J02, J02.9, J04, J04.0, J04.1, J04.2, J06, J06.0, J06.9) in the presence of clinical manifestations and confirmation of the etiology of the disease by laboratory tests (PCR method). Patients were included in the study after one of the patient's parents/adoptive parents and the patient signed an informed consent to participate in the study. The interval between the appearance of the first symptoms of the disease and the inclusion of the patient in the study did not exceed 36 hours. RESULTS: As a result of a clinical study, the efficacy and safety of treatment with riamilovir (Triazavirin®) in sick children aged 12-17 years with a diagnosis of ARVI was shown. A decrease in the duration of the disease was shown when using the drug riamilovir (Triazavirin®) compared with the control group. No serious adverse events were detected during the study. CONCLUSION: As a result of the conducted clinical study, the high efficacy, safety and good tolerability of the drug riamilovir in the treatment of children aged 12-17 years with a diagnosis of ARVI was established. It is recommended to use the drug riamilovir in clinical practice as an etiotropic therapy in children aged 12-17 years with a diagnosis of ARVI due to its high efficacy and safety.
Assuntos
Influenza Humana , Infecções Respiratórias , Viroses , Humanos , Criança , Influenza Humana/tratamento farmacológico , Antivirais/efeitos adversos , Viroses/tratamento farmacológico , Infecções Respiratórias/tratamento farmacológicoRESUMO
AIM: In this study we evaluated the effects of Riamilovir on SARS-CoV-2 viral shedding and on admission duration in patients with moderate COVID-19. MATERIALS AND METHODS: We have used data from 69 health records of patients with moderate severe PCR confirmed SARS-CoV-2 infection. Control group included 34 patients treated with off-label riamilovir 1250 mg per day for 5 days (250 mg 5 times a day), comparison groups 35 patients, who received ribavirin and umifenovir 800 mg a day for 5 days. The antiviral therapy was administered within 72 hours from the onset of the disease. The primary endpoints were elimination of virus in oropharyngeal and nasopharyngeal swabs on 7 day of admission and discharge from the hospital by 14 day. RESULTS: Patients assigned to riamilovir had significantly shorter time to clinical improvement as well as increased PCR negative rate by day 7. CONCLUSION: Yearly administration of riamilovir as opposed to the umifenovir and ribavirin in therapy of moderate SARS-CoV-2 infection was associated with significant shorter time to clinical improvement by 14 day of hospitalization. PCR negative rate by 7 days of hospitalization is significantly more likely in riamilovir group.
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AIM: The assessment of the effectiveness, safety and tolerance of the drug Riamilovir for emergency drug prevention in the foci of a new coronavirus infection (COVID-19). MATERIALS AND METHODS: The trial included 113 persons aged 18 years and older who had level 1 contacts with patients with a new coronavirus infection (COVID-19), who had not previously been ill, with negative PCR results for COVID-19. RESULTS: The high effectiveness, safety and good tolerance of the preventive use of the drug Riamilovir for the period of 20 days of taking a prophylactic dose of 1 capsule (250 mg) per day in the foci of COVID-19 has been established. CONCLUSION: The effectiveness and safety of the preventive use of the drug Riamilovir allow to recommend it for emergency drug prophylaxis in contact persons in the foci of a new coronavirus infection (COVID-19).
RESUMO
AIM: Evaluation of efficacy, safety, tolerability, and determination of the optimal dose of riamilovir in patients diagnosed with acute respiratory viral infection (ARVI). MATERIALS AND METHODS: The study included 270 patients with uncomplicated ARVI of mild and moderate severity (with a laboratory-confirmed PCR method for the presence of ARVI antigens, absence of influenza virus antigens). Patients were included in the study after signing an informed consent. Patients were randomized into 3 groups in a 1:1:1 ratio of 90 patients in each group. Completed the study in accordance with the Protocol: 267 patients. The study involved patients diagnosed with ARVI. RESULTS: Confirmed the efficacy, safety and tolerability of the drug riamilovir. Adverse drug reactions associated, in the opinion of the doctor, with taking the drug and resulting in discontinuation of the drug, were not noted in this study. CONCLUSION: As a result of clinical study, the effectiveness of both ARVI treatment regimens with drug riamilovir has been shown. There were no differences in the effectiveness and safety of the proposed treatment regimens. Practical use of both treatment regimens is recommended. However, according to the authors, taking the drug 3 times a day is much more convenient for patients, improves the quality of life and adherence to therapy.
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Infecções Respiratórias , Viroses , Antivirais/efeitos adversos , Humanos , Reação em Cadeia da Polimerase , Qualidade de Vida , Infecções Respiratórias/tratamento farmacológico , Viroses/tratamento farmacológicoRESUMO
Prophylactic efficacy of Triazavirin against experimental Forest-Spring encephalitis was studied on albino mice. vs. the active drug Ribavirin. A significant increase of the animal lifespan in the test groups (from 4 to 5 days) and a statistically (p < or = 0.05) valid decrease of the virus accumulation level in the target organ (the brain) were observed.
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Azóis/farmacologia , Encefalite Transmitida por Carrapatos/prevenção & controle , Triazinas/farmacologia , Animais , Encéfalo/metabolismo , Encéfalo/patologia , Encéfalo/virologia , Linhagem Celular , Modelos Animais de Doenças , Encefalite Transmitida por Carrapatos/metabolismo , Encefalite Transmitida por Carrapatos/patologia , Camundongos , Suínos , TriazóisRESUMO
The comparative study of the therapeutic efficacy of Triazavirin against experimental Forest-Spring encephalitis on albino mice vs. the active drug Ribavirin® showed that in high doses (200-400 mg/kg) Triazavirin moderately protected the infected animals. A significant increase of the animal lifespan in the test groups (from 4.1 to 4.8 days) and a statistically (p ≤ 0.05) valid decrease of the virus accumulation in the target organ (the brain) were observed.