ABSTRACT
Post-COVID syndrome develops after COVID-19 (COronaVIrus Disease 2019) and leads to cumulative effects in the form of shortness of breath and impaired lung function. Notably, patients with airway inflammation and COVID-19 were found to have increased concentrations of hyaluronic acid (HA). Since bovhyaluronidase azoximer (Longidase) catalyzes the hydrolysis of HA, this drug has the potential to reduce HA levels and improve lung function in patients with post-COVID syndrome. The aim of the DISSOLVE trial, which was conducted early in the pandemic, was to investigate the efficacy and safety of bovhyaluronidase azoximer in patients with symptoms associated with post-COVID syndrome. Methods. An open, prospective, controlled, comparative, multicenter clinical trial (NCT04645368) included adult patients (n = 160) who had post-COVID syndrome. Patients in the treatment group (n = 81) received bovhyaluronidase azoximer, and individuals in the control group (n = 79) were followed up without intervention. The study included physical examination, evaluation of forced vital capacity (FVC), assessment of dyspnea with the Modified Medical Research Council Dyspnea Scale (mMRC), 6-minute walking test, and pulse oximetry. These indicators were measured on 3 visits, at days 1 (baseline), 75, and 180. In addition, the number of patients who experienced adverse events and serious adverse events were recorded. Results. Baseline patient characteristics in the treatment group and the control group were similar. In the treatment group, there was a statistically significant reduction in residual pulmonary abnormalities after visit 2 (day 75) and visit 3 (day 180). In addition, FVC, pulse oximetry values, and functional exercise tolerance increased statistically significantly at days 75 and 180 compared to baseline. The mMRC scores for dyspnea decreased statistically significantly in the treatment group over 75 days. The safety profile of the drug was reported to be favorable throughout the study. Conclusion. Treatment with bovhyaluronidase azoximer in patients with post-COVID syndrome showed improvement in FVC, pulse oximetry, functional exercise tolerance, and mMRC dyspnea.Copyright © Chuchalin A.G. et al., 2023.
ABSTRACT
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterized by a high level of morbidity and mortality and is associated with significant social and economic damage to the health system and society. COPD and COVID-19 have many potentially negative relationships that can lead to worse outcomes of COVID-19, including impaired lung function, old age and the presence of concomitant diseases Aim. To assess efficacy and safety of the drug Tixagevimab + Cilgavimab for the pre-contact prevention of COVID-19 infection in patients with COPD. MATERIAL AND METHODS: A total of 324 male patients were included in the study, who were treated or monitored at the Regional Clinic Hospital â3 and the Regional Pulmonological Center of Chelyabinsk in April-May 2022. The main endpoints of observation, for 3 and 6 months, to assess the effectiveness were the dynamics of shortness of breath according to The Modified Medical Research Council Dyspnea Scale - mMRC, the The forced expiratory volume in 1 second, the number of exacerbations, emergency calls, hospitalizations, polymerase chain reaction for SARS-CoV-2. Local and general reactions after immunization were evaluated. The drug Evusheld (150 mg Tixsagevimab +150 mg Cilgavimab, AstraZeneca) was used for immunization. RESULTS AND CONCLUSION: The effectiveness of pre-contact prevention of COVID-19 was 88.8%. The administration of the drug does not provoke an exacerbation of the underlying disease. The main clinical and functional indicators have positive dynamics by the 6th month of follow-up. The drug is well tolerated and has no significant both early and late complications.
Subject(s)
COVID-19 , Pulmonary Disease, Chronic Obstructive , Humans , Male , COVID-19/prevention & control , SARS-CoV-2 , Pulmonary Disease, Chronic Obstructive/therapy , Immunization , Antibodies, Monoclonal/therapeutic useABSTRACT
Post-COVID syndrome develops after COVID-19 (COronaVIrus Disease 2019) and leads to cumulative effects in the form of shortness of breath and impaired lung function. Notably, patients with airway inflammation and COVID-19 were found to have increased concentrations of hyaluronic acid (HA). Since bovhyaluronidase azoximer (Longidase®) catalyzes the hydrolysis of HA, this drug has the potential to reduce HA levels and improve lung function in patients with post-COVID syndrome. The aim of the DISSOLVE trial, which was conducted early in the pandemic, was to investigate the efficacy and safety of bovhyaluronidase azoximer in patients with symptoms associated with post-COVID syndrome. Methods. An open, prospective, controlled, comparative, multicenter clinical trial (NCT04645368) included adult patients (n = 160) who had post-COVID syndrome. Patients in the treatment group (n = 81) received bovhyaluronidase azoximer, and individuals in the control group (n = 79) were followed up without intervention. The study included physical examination, evaluation of forced vital capacity (FVC), assessment of dyspnea with the Modified Medical Research Council Dyspnea Scale (mMRC), 6-minute walking test, and pulse oximetry. These indicators were measured on 3 visits, at days 1 (baseline), 75, and 180. In addition, the number of patients who experienced adverse events and serious adverse events were recorded. Results. Baseline patient characteristics in the treatment group and the control group were similar. In the treatment group, there was a statistically significant reduction in residual pulmonary abnormalities after visit 2 (day 75) and visit 3 (day 180). In addition, FVC, pulse oximetry values, and functional exercise tolerance increased statistically significantly at days 75 and 180 compared to baseline. The mMRC scores for dyspnea decreased statistically significantly in the treatment group over 75 days. The safety profile of the drug was reported to be favorable throughout the study. Conclusion. Treatment with bovhyaluronidase azoximer in patients with post-COVID syndrome showed improvement in FVC, pulse oximetry, functional exercise tolerance, and mMRC dyspnea. © Chuchalin A.G. et al., 2023.
ABSTRACT
Aim - to evaluate the efficacy and safety of olokizumab in hospitalized patients with moderate to severe coronavirus disease COVID-19. Material and methods. A multicenter non-interventional retrospective study of olokizumab treatment in hospitalized patients with COVID-19 was conducted. The initial population in this study included 2926 patients with COVID-19. Patients with moderate or severe disease who were taking corticosteroids as part of standard therapy were selected for this analysis. The final population was 1738 patients. A test group (standard therapy: corticosteroids, antiviral, pathogenetic or symptomatic therapy in combination with olokizumab) and a comparison group (standard therapy only) were formed. Each group included 869 patients. The primary end point was all-cause mortality from the start of anti-inflammatory therapy to the end of follow-up. We also analyzed the incidence of transfer and the length of stay of patients in the intensive care unit, the duration of hospitalization, as well as the change in C-reactive protein level. Results and discussion. It was found that olokizumab significantly reduces the all-cause mortality compared with standard therapy: 54 (6.21%) cases compared with 111 (12.77%) in the control arm, p<0.001, odds ratio (OR) 2.21 [1.57;3.1]. The results of factor analysis confirmed that olokizumab increases the odds of recovery, OR 2.41 (95% CI 1.64-3.54, p<0.001). In addition, patients in olokizumab group showed significantly lower plasma CRP levels compared with control group. Already on the 2nd day after the start of therapy the CRP level was almost 2 times lower in the olokizumab group than in the control group (the median was 13 [5.6;28.55] mg/l and 25 [15.3;79.25] mg/L in the olokizumab and comparison groups, respectively). Conclusion. The results of the study confirm the clinical data on the efficacy of olokizumab as therapy for COVID-19 patients.Copyright © 2022 Tomsk Polytechnic University, Publishing House. All rights reserved.
ABSTRACT
Post-COVID syndrome develops after COVID-19 (COronaVIrus Disease 2019) and leads to cumulative effects in the form of shortness of breath and impaired lung function. Notably, patients with airway inflammation and COVID-19 were found to have increased concentrations of hyaluronic acid (HA). Since bovhyaluronidase azoximer (Longidase) catalyzes the hydrolysis of HA, this drug has the potential to reduce HA levels and improve lung function in patients with post-COVID syndrome. The aim of the DISSOLVE trial, which was conducted early in the pandemic, was to investigate the efficacy and safety of bovhyaluronidase azoximer in patients with symptoms associated with post-COVID syndrome. Methods. An open, prospective, controlled, comparative, multicenter clinical trial (NCT04645368) included adult patients (n = 160) who had post-COVID syndrome. Patients in the treatment group (n = 81) received bovhyaluronidase azoximer, and individuals in the control group (n = 79) were followed up without intervention. The study included physical examination, evaluation of forced vital capacity (FVC), assessment of dyspnea with the Modified Medical Research Council Dyspnea Scale (mMRC), 6-minute walking test, and pulse oximetry. These indicators were measured on 3 visits, at days 1 (baseline), 75, and 180. In addition, the number of patients who experienced adverse events and serious adverse events were recorded. Results. Baseline patient characteristics in the treatment group and the control group were similar. In the treatment group, there was a statistically significant reduction in residual pulmonary abnormalities after visit 2 (day 75) and visit 3 (day 180). In addition, FVC, pulse oximetry values, and functional exercise tolerance increased statistically significantly at days 75 and 180 compared to baseline. The mMRC scores for dyspnea decreased statistically significantly in the treatment group over 75 days. The safety profile of the drug was reported to be favorable throughout the study. Conclusion. Treatment with bovhyaluronidase azoximer in patients with post-COVID syndrome showed improvement in FVC, pulse oximetry, functional exercise tolerance, and mMRC dyspnea.Copyright © Chuchalin A.G. et al., 2023.
ABSTRACT
Aim – to evaluate the efficacy and safety of olokizumab in hospitalized patients with moderate to severe coronavirus disease COVID-19. Material and methods. A multicenter non-interventional retrospective study of olokizumab treatment in hospitalized patients with COVID-19 was conducted. The initial population in this study included 2926 patients with COVID-19. Patients with moderate or severe disease who were taking corticosteroids as part of standard therapy were selected for this analysis. The final population was 1738 patients. A test group (standard therapy: corticosteroids, antiviral, pathogenetic or symptomatic therapy in combination with olokizumab) and a comparison group (standard therapy only) were formed. Each group included 869 patients. The primary end point was all-cause mortality from the start of anti-inflammatory therapy to the end of follow-up. We also analyzed the incidence of transfer and the length of stay of patients in the intensive care unit, the duration of hospitalization, as well as the change in C-reactive protein level. Results and discussion. It was found that olokizumab significantly reduces the all-cause mortality compared with standard therapy: 54 (6.21%) cases compared with 111 (12.77%) in the control arm, p<0.001, odds ratio (OR) 2.21 [1.57;3.1]. The results of factor analysis confirmed that olokizumab increases the odds of recovery, OR 2.41 (95% CI 1.64–3.54, p<0.001). In addition, patients in olokizumab group showed significantly lower plasma CRP levels compared with control group. Already on the 2nd day after the start of therapy the CRP level was almost 2 times lower in the olokizumab group than in the control group (the median was 13 [5.6;28.55] mg/l and 25 [15.3;79.25] mg/L in the olokizumab and comparison groups, respectively). Conclusion. The results of the study confirm the clinical data on the efficacy of olokizumab as therapy for COVID-19 patients. © 2022 Tomsk Polytechnic University, Publishing House. All rights reserved.
ABSTRACT
The article presents data on the use of nebulizer therapy for major respiratory diseases: chronic obstructive pulmonary disease (COPD), bronchial asthma. The conditions for using aerosol-producing devices for new COVID-19 coronavirus infection, in the hospital and at home are also given. Historical aspects of the creation and use of devices for nebulizer therapy are considered. A differentiated approach is given when choosing an inhaler depending on the clinical situation, taking into account the need to use devices with a high level of precipitated fine particle fraction of the pharmaceutical aerosol, external minimal losses, with a reduced inhalation time and an economical treatment regime with optimal medication consumption. These advantages are inherent to nebulizers of the company PARI: PARI BOY SX and VELOX®. In patients with COPD, options for using nebulizer therapy in a stable state and in exacerbation are considered. It is emphasized that the inhaled route of administration of drugs provides direct penetration of the drug into the respiratory tract and, thus, contributes to a more effective drug effect. In addition, the inhalation route of administration reduces the potential risk of side effects. In patients with bronchial asthma, priority is given to the appointment of inhaled corticosteroids and β2-agonists in exacerbation. Data on the main types of devices, their advantages and disadvantages are provided. In conclusion, it is concluded that nebulizer therapy is a modern way to deliver the drug to the respiratory tract. In a number of clinical situations, the use of nebulizers is the only way to deliver the drug to a pathological focus. The use of nebulizers significantly expands the treatment options for patients with COPD and BA, reduces the need for hospitalization, and prevents the development of severe exacerbations. © 2020, Remedium Group Ltd. All rights reserved.
ABSTRACT
Most subjects with the COVID-19 experience mild to moderate symptoms, but approximately 10% of cases suffer from severe course of disease. IL-6 inhibitors are actively used to neutralize and prevent the cytokine storm. Olokizumab is a humanized monoclonal antibody belonging to the G4/Kappa immunoglobulin isotype that selectively binds to human IL-6 and effectively neutralizes it. AIM: To evaluate the efficacy and safety of Artlegia (olokizumab) for the treatment of subjects with a disease caused by the SARS-COV-2 virus in a real-world clinical setting. MATERIALS AND METHODS: The analysis included data of 610 subjects aged 55.0812.68 years who received olokizumab at a single dose of 160 mg/mL 0.4 mL subcutaneously as a preemptive anti-inflammatory therapy. The comparison group included 511 subjects aged 55.2311.23 years who received standard therapy without IL-6 inhibitors. Control Endpoints: 1. Positive clinical changes on Day 7. 2. Changes in the CRP levels on Days 1, 2, and 7. 3. Duration of oxygen therapy. 4. Number of days in hospital. 5. Number of adverse events. 6. Disease outcome. RESULTS: If a cytokine storm occurs, immune regulatory events will trigger the development of either a protective immune response or an exacerbated inflammatory response. The use of preemptive anti-inflammatory therapy has both a short-term and, most importantly, a long-term effect on the T and B parts of the immune process. These aspects definitely require further research and observation. CONCLUSION: The use of olokizumab to treat the new COVID-19 coronavirus disease has demonstrated a positive effect on clinical and laboratory parameters. Primarily, it affects the severity of clinical parameters by improving the general condition already on the first day of observation, and decreasing body temperature to normal values. The changes in the C-reactive protein levels show a significant effect of the IL-6 inhibitor on the systemic inflammatory response.