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Therapy with neutralizing monoclonal antibodies (mAbs) is particularly relevant during COVID-19 outbreaks in patients at high risk of severe disease, including kidney transplant recipients (KTRs). Objective(s): to evaluate the efficacy and safety of neutralizing mAbs in KTRs with mild to moderate COVID-19. Materials and methods. The retrospective study included 99 KTRs who received inpatient treatment for COVID-19 between September 1 and December 31, 2021. Patients were 52.0 +/- 11.5 years old (M, 47.5%). Bamlanivimab/etesevimab combination drug at a dose of 700/1400 mg was used as mAbs. To evaluate the efficacy of mAbs therapy, two groups of patients were identified. Group 1 consisted of 33 KTRs who received mAbs as one of the therapy components, while group 2 consisted of 66 patients who received no mAbs. Discharge from the hospital or death was considered as the endpoint of follow-up. Results. In group 1, after the use of mAb, progression of pulmonary process was observed less frequently than in the control group with CT1-2 transformation to CT3-4 (9.1% vs. 30.3%, respectively, p < 0.01). Group 1 KTRs differed significantly from group 2 - lower need for ICU and ventilator care (6.1% vs. 27.3% and 3% vs. 19.8%, respectively). The groups were comparable by sex, age, body mass index, Charlson Comorbidity Index (CCI) and time after kidney transplant (KTx) at the onset of the disease and by aseline blood biochemistry parameter values at the time of hospitalization. Only C-reactive protein (CRP) and fibrinogen values were higher in the non-mAbs patients who were hospitalized later in the course of the disease (7.7 +/- 3.2 days versus 4.6 +/- 1.6 days in group 1, p < 0.001). The frequency of prescription of other therapies did not differ between the compared groups. Use of mAbs significantly reduced mortality from 19.7% in KTRs in group 2 to 3% in group 1 without adverse effect on graft function. Conclusion. The use of mAbs therapy in the early stages of COVID-19 in KTRs is safe, it prevents severe COVID-19, and reduces the incidence of adverse outcomes.Copyright © 2023 Russian Transplant Society. All rights reserved.
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Therapy with neutralizing monoclonal antibodies (mAbs) is particularly relevant during COVID-19 outbreaks in patients at high risk of severe disease, including kidney transplant recipients (KTRs). Objective: to evaluate the efficacy and safety of neutralizing mAbs in KTRs with mild to moderate COVID-19. Materials and methods. The retrospective study included 99 KTRs who received inpatient treatment for COVID-19 between September 1 and December 31, 2021. Patients were 52.0 +/- 11.5 years old (M, 47.5%). Bamlanivimab/etesevimab combination drug at a dose of 700/1400 mg was used as mAbs. To evaluate the efficacy of mAbs therapy, two groups of patients were identified. Group 1 consisted of 33 KTRs who received mAbs as one of the therapy components, while group 2 consisted of 66 patients who received no mAbs. Discharge from the hospital or death was considered as the endpoint of follow-up. Results. In group 1, after the use of mAb, progression of pulmonary process was observed less frequently than in the control group with CT1-2 transformation to CT3-4 (9.1% vs. 30.3%, respectively, p < 0.01). Group 1 KTRs differed significantly from group 2 - lower need for ICU and ventilator care (6.1% vs. 27.3% and 3% vs. 19.8%, respectively). The groups were comparable by sex, age, body mass index, Charlson Comorbidity Index (CCI) and time after kidney transplant (KTx) at the onset of the disease and by.aseline blood biochemistry parameter values at the time of hospitalization. Only C-reactive protein (CRP) and fibrinogen values were higher in the non-mAbs patients who were hospitalized later in the course of the disease (7.7 +/- 3.2 days versus 4.6 +/- 1.6 days in group 1, p < 0.001). The frequency of prescription of other therapies did not differ between the compared groups. Use of mAbs significantly reduced mortality from 19.7% in KTRs in group 2 to 3% in group 1 without adverse effect on graft function. Conclusion. The use of mAbs therapy in the early stages of COVID-19 in KTRs is safe, it prevents severe COVID-19, and reduces the incidence of adverse outcomes.
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Objective. Evaluation of clinical observation, the course, the risk factors, and treatment options for SARS-CoV-2 infection in hemodialysis patients with end-stage chronic kidney disease. Material and methods. The retrospective, single-center, uncontrolled study involved 231 patients (132 M/99 W) aged 61.7+/-14.7 years with COVID-19 diagnosed. The SPSS software package was used for statistical analysis. Results. 72 (31.2%) of patients died, 68 (94.4%) of them had ARDS as the main cause of death. Comparative analysis in groups with favorable and unfavorable outcomes of the disease showed that age (68.1+/- 13.2 years vs 58.7+/-14.5 years, p<0.0001) and the comorbidity index (8.8+/-2.2 vs 6.2+/-2.6, p<0.0001) were significantly higher in those who have died compared to survivors. According to CT data, they were more likely to have 3rd or 4th-degree lung damage (72.2 vs 36.5%, p<0.0001), and the minimum oxygen saturation index: 67.6+/-12.8 and 87.8+/-10.9%, respectively (p<0.0001). Somorbidity index and the need for invasive ventilation were independent predictors of the fatal outcome of COVID-19. Early administration of monoclonal antibodies to IL-6 (in the first 3 days after hospitalization) in patients with a low prevalence of the pulmonary process (CT stage 1-2) was associated with a significantly lower frequency of fatal outcome. Conclusions. SARS-CoV-2 infection in HD patients is characterized by a high rate of mortality. Predictors of severe disease in this population are comorbidity index and the need for invasive ventilation.Copyright © Infectious Diseases: News, Opinions, Training.
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Patients with end-stage chronic kidney disease treated with hemodialysis are at risk of infection and severe course of the new coronavirus infection. This opinion was based on the data obtained as a result of PCR testing during the active phase of the disease with detailed clinical symptoms. However, this diagnostic method does not allow one to fully assess the prevalence of infection in the population. The aim - studying of the frequency of SARS-CoV-2 infection in patients receiving hemodialysis treatment and the spectrum of antiviral antibodies, depending on the nature of the course of COVID-19. Material and methods. 100 patients with chronic kidney disease (stage 5D) treated at the outpatient Dialysis Center (MCVTP) were included in the study by a simple random sample. The assessment of SARS-CoV-2 infection was carried out by analyzing the material of smears obtained from the naso-oropharynx by PCR and blood serum samples by ELISA. The study excluded 14 patients with dubious results for the determination of serological markers SARS-CoV-2 and 1 patient with active infection, who was isolated from the RNA of the virus. Results. IgM and IgG antibodies were detected in 49 (57.6%) of the 85 examined patients. 24 of them (group 1) were diagnosed with COVID-19 infection with typical clinical symptoms 3-9 months ago, and 25 (group 2) had no clinical manifestations of the acute respiratory infection at the appropriate time suggesting an asymptomatic course of the disease. IgM class antibodies were detected with equal frequency in group 1 and in group 2 (33.3 vs 24.0%, respectively, p<0.6). IgG antibodies exclusively to the nucleocapsid N-protein (IgGn) were detected only in the latent form of the disease (32%), while antibodies against the S-protein (spike protein) of the virus (IgGs and IgGn+s) were detected more often in the manifest form compared to the asymptomatic one (100 vs 60%, respectively, p<0.05). Conclusion. In a random cohort of patient receiving hemodialysis treatment, more than half were asymptomatic.Despite a wide range of prevention measures, SARS-CoV-2 infection among patients treated with hemodialysis is more than 2 times higher than in the general population.Copyright © 2021 Geotar Media Publishing Group. All rights reserved.
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Patients with end-stage kidney disease undergoing hemodialysis have one of the highest COVID-19 mortality rates. The use of innovative methods capable of optimizing their treatment outcomes is important for clinical practice. Aims - to investigate the efficacy and safety of neutralizing monoclonal antibodies in COVID-19 patients treated with hemodialysis. Material and methods. We conducted a retrospective controlled single-center study with 102 COVID-19 patients on maintenance hemodialysis involved (M: 67;65.7%;W: 35;34.3%), aged 57.2+/-15.3 years. PCR-detected SARS-CoV-2 infection was diagnosed in all patients. Neutralizing monoclonal antibodies were administered to 69 patients, who formed the study group (group 1). The control group included 33 patients (group 2). The combination of bamlanevimab and etesevimab was the most frequent therapy used (in 59 patients). Results. In the course of the disease, group 1 patients, compared to those of group 2, had statistically significantly higher blood oxygen saturation values (94.2+/-5.7 vs 89.8+/-10.7);they required less frequent oxygen support (29.0 vs 54.5%) and ICU treatment (18.8 vs 48.5%), respectively. Fatal outcomes occurred in 4 (5.8%) of 69 patients who received neutralizing antibodies and in 6 (18.2%) of 33 patients who did not receive the therapy, p<0.05. Except for one patient, all other patients in both groups developed an unfavorable outcome due to progressive lung damage. However, only 4 of 6 (2/3) patients with progressive lung damage died in group 1, whereas the similar course of the disease proved fatal in all cases in group 2. Conclusion. The use of neutralizing monoclonal antibodies in hemodialysis patients is safe and effective when the drugs are administered early, the pulmonary process progression is insignificant and dominant SARSCoV-2 variants are sensitive to them.Copyright © 2022 Tomsk Polytechnic University, Publishing House. All rights reserved.
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Patients with end-stage kidney disease undergoing hemodialysis have one of the highest COVID-19 mortality rates. The use of innovative methods capable of optimizing their treatment outcomes is important for clinical practice. Aims – to investigate the efficacy and safety of neutralizing monoclonal antibodies in COVID-19 patients treated with hemodialysis. Material and methods. We conducted a retrospective controlled single-center study with 102 COVID-19 patients on maintenance hemodialysis involved (M: 67;65.7%;W: 35;34.3%), aged 57.2±15.3 years. PCR-detected SARS-CoV-2 infection was diagnosed in all patients. Neutralizing monoclonal antibodies were administered to 69 patients, who formed the study group (group 1). The control group included 33 patients (group 2). The combination of bamlanevimab and etesevimab was the most frequent therapy used (in 59 patients). Results. In the course of the disease, group 1 patients, compared to those of group 2, had statistically significantly higher blood oxygen saturation values (94.2±5.7 vs 89.8±10.7);they required less frequent oxygen support (29.0 vs 54.5%) and ICU treatment (18.8 vs 48.5%), respectively. Fatal outcomes occurred in 4 (5.8%) of 69 patients who received neutralizing antibodies and in 6 (18.2%) of 33 patients who did not receive the therapy, p<0.05. Except for one patient, all other patients in both groups developed an unfavorable outcome due to progressive lung damage. However, only 4 of 6 (2/3) patients with progressive lung damage died in group 1, whereas the similar course of the disease proved fatal in all cases in group 2. Conclusion. The use of neutralizing monoclonal antibodies in hemodialysis patients is safe and effective when the drugs are administered early, the pulmonary process progression is insignificant and dominant SARSCoV-2 variants are sensitive to them. © 2022 Tomsk Polytechnic University, Publishing House. All rights reserved.
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BACKGROUND: Present concepts of the novel coronavirus infection prognosis in haemodialysis (HD) patients are rather controversial. There is little information on therapy efficiency and safety in such patients. We studied COVID-19 course specifics, prognostic factors associated with fatal outcomes, therapy efficiency and its transformation at different stages of the pandemic first year. MATERIALS AND METHODS: Single-centre retrospective uncontrolled study included 653 COVID-19 HD-patients treated at Moscow City Nephrology Centre from April 1 to December 31, 2020. RESULTS: This period mortality rate was 21.0%. Independent predictors of COVID-19 unfavourable outcome in HD patients were pulmonary lesion extension (CT grades 34), high comorbidity index, and mechanical ventilation. Approaches to COVID-19 treatment modified significantly at different periods. Immunomodulatory drugs (monoclonal antibodies to IL-6, corticosteroids) were used largely at later stages. With tocilizumab administration, mortality was 15.1%, tocilizumab together with dexamethasone 13.3%; without them 37.8% (Ñ0,001). Tocilizumab administration in the first 3 days after hospitalization of patients with CT grades 12 was associated with more favourable outcomes: 1 out of 29 died vs 6 out of 20 (tocilizumab administered at later periods); p0.04. There was no significant difference in death frequency in patients with CT grades 34 depending on tocilizumab administration time. CONCLUSION: COVID-19 in HD patients can manifest in a severe course with unfavourable outcome. It is urgent to identify reliable disease outcome predictors and develop efficient treatment in this population.
Asunto(s)
COVID-19 , Pandemias , Humanos , COVID-19/epidemiología , COVID-19/terapia , Estudios Retrospectivos , Interleucina-6 , Resultado del Tratamiento , Diálisis Renal , Anticuerpos Monoclonales , DexametasonaRESUMEN
In the context of the COVID-19 pandemic, patients with end-stage CKD receiving hemodialysis replacement therapy (HD) were at risk of SARS-CoV-2 infection due to the specifics of treatment and the immunodeficiency state caused by uremia. The aim of the study was to analyze the characteristics of the course, prognostically unfavorable factors, and outcome of COVID-19 in HD patients of the second wave of the pandemic. Materials and methods: a retrospective study was carried out on the material of observations of 325 HD patients infected with SARS-CoV-2 in the period from 09/01/2020 to 12/31/2020. The patients' age was 60.1±14.0 years. The duration of HD treatment was 30.0 (9.5;66.0) months. The endpoint was taken as the discharge from the hospital or death. Results: in 264 out of 325 (81.2%) patients, the diagnosis of COVID-19 was confirmed by the identification of SARS-CoV-2 RNA. CT scan of the chest showed signs of viral pneumonia in all patients. Mortality was 15.1% (49 out of 325 pts). In 79.7% of patients, the cause of death was ARDS. Comparative analysis showed that patients with a fatal outcome (group 2) were older (69.2±10.6 years) than patients with a successful course (group 1) of the disease (58.5±13.9 years), and differed in higher comorbidity index (7.8±1.9 versus 5.9±2.2, respectively). SpO2 in groups 2 and 1 was 65.2±10.1% and 92.1±6.4%, respectively (p<0.001). In the deceased patients, anemia, leukocytosis, thrombocytopenia, and hypoalbuminemia were significantly more pronounced, as well as indicators of GGT, alkaline phosphatase, ferritin, CRP, LDH, and D-dimer. In the fatal group, the proportion of patients with a procalcitonin level of more than 2 ng/ml was also higher. In multivariate analysis, only high comorbidity index and the need for mechanical ventilation were the independent predictors of the unfavorable outcome. In the group of patients with the favorable outcome, the combined therapy with immunobiological drugs and dexamethasone were used significantly more often than in the deceased group, while the frequency of their “isolated” use in the compared groups was comparable. Conclusions: COVID-19 in HD patients is characterized by severe course and high mortality. Independent predictors of an unfavorable outcome of the disease were a high comorbidity index and the need for invasive lung ventilation. Early use of immunobiological drugs and dexamethasone in combination with anticoagulants increases the effectiveness of treatment of severe forms of SARS-CoV-2 infection in HD patients. © 2021 JSC Vidal Rus. All rights reserved.
RESUMEN
Patients with end-stage chronic kidney disease treated with hemodialysis are at risk of infection and severe course of the new coronavirus infection. This opinion was based on the data obtained as a result of PCR testing during the active phase of the disease with detailed clinical symptoms. However, this diagnostic method does not allow one to fully assess the prevalence of infection in the population. The aim – studying of the frequency of SARS-CoV-2 infection in patients receiving hemodialysis treatment and the spectrum of antiviral antibodies, depending on the nature of the course of COVID-19. Material and methods. 100 patients with chronic kidney disease (stage 5D) treated at the outpatient Dialysis Center (MCVTP) were included in the study by a simple random sample. The assessment of SARS-CoV-2 infection was carried out by analyzing the material of smears obtained from the naso-oropharynx by PCR and blood serum samples by ELISA. The study excluded 14 patients with dubious results for the determination of serological markers SARS-CoV-2 and 1 patient with active infection, who was isolated from the RNA of the virus. Results. IgM and IgG antibodies were detected in 49 (57.6%) of the 85 examined patients. 24 of them (group 1) were diagnosed with COVID-19 infection with typical clinical symptoms 3–9 months ago, and 25 (group 2) had no clinical manifestations of the acute respiratory infection at the appropriate time suggesting an asymptomatic course of the disease. IgM class antibodies were detected with equal frequency in group 1 and in group 2 (33.3 vs 24.0%, respectively, p<0.6). IgG antibodies exclusively to the nucleocapsid N-protein (IgGn) were detected only in the latent form of the disease (32%), while antibodies against the S-protein (spike protein) of the virus (IgGs and IgGn+s) were detected more often in the manifest form compared to the asymptomatic one (100 vs 60%, respectively, p<0.05). Conclusion. In a random cohort of patient receiving hemodialysis treatment, more than half were asymptomatic.Despite a wide range of prevention measures, SARS-CoV-2 infection among patients treated with hemodialysis is more than 2 times higher than in the general population. © 2021 Geotar Media Publishing Group. All rights reserved.
RESUMEN
Objective. Evaluation of clinical observation, the course, the risk factors, and treatment options for SARS-CoV-2 infection in hemodialysis patients with end-stage chronic kidney disease. Material and methods. The retrospective, single-center, uncontrolled study involved 231 patients (132 M/99 W) aged 61.7±14.7 years with COVID-19 diagnosed. The SPSS software package was used for statistical analysis. Results. 72 (31.2%) of patients died, 68 (94.4%) of them had ARDS as the main cause of death. Comparative analysis in groups with favorable and unfavorable outcomes of the disease showed that age (68.1± 13.2 years vs 58.7±14.5 years, p<0.0001) and the comorbidity index (8.8±2.2 vs 6.2±2.6, p<0.0001) were significantly higher in those who have died compared to survivors. According to CT data, they were more likely to have 3rd or 4th-degree lung damage (72.2 vs 36.5%, p<0.0001), and the minimum oxygen saturation index: 67.6±12.8 and 87.8±10.9%, respectively (p<0.0001). Сomorbidity index and the need for invasive ventilation were independent predictors of the fatal outcome of COVID-19. Early administration of monoclonal antibodies to IL-6 (in the first 3 days after hospitalization) in patients with a low prevalence of the pulmonary process (CT stage 1-2) was associated with a significantly lower frequency of fatal outcome. Conclusions. SARS-CoV-2 infection in HD patients is characterized by a high rate of mortality. Predictors of severe disease in this population are comorbidity index and the need for invasive ventilation. © Infectious Diseases: News, Opinions, Training.