Post-exposure prophylaxis of COVID-19: results of double-blind, placebo-controlled, multicenter clinical study evaluation of efficacy and safety of double-stranded sodium salt RNA drug

The aim of the study was to evaluate the efficacy and safety of an RNA double-stranded sodium salt drug, a lyophilisate for a solution preparation for an intramuscular and subcutaneous administration, as a means of post-exposure COVID-19 prophylaxis in comparison with placebo.Material and methods. A double-blind, placebo-controlled, multicenter, randomized phase III clinical trial was conducted to evaluate the efficacy and safety of a double-stranded sodium salt RNA drug (RADAM IN (R) VIRO), a lyophilisate for preparing a solution for intramuscular and subcutaneous administration as a means of post-exposure prophylaxis of COVID-19. The study was conducted in 10 research centers in the Russian Federation from May 31, 2022 to January 17, 2023. The study included men and women aged =18 years who cohabitate with a person with a documented COVID-19 diagnosis and do not have symptoms characteristic of COVID-19. At the randomization stage, the subjects were assigned to one of two groups: group 1 (n=400) received a study drug RADAM IN (R) VIRO 5 mg (1 vial) intramuscularly once a day;group 2 (n=400) received placebo 1 vial intramuscularly once a day. The total duration of the study for each subject was no more than 30 days.Results. By day 10-11, in the double-stranded sodium salt RNA drug group, the proportion of the subjects with confirmed COVID-19 and at least 1 symptom characteristic of COVID-19 was 5.76% (23/399), and in the placebo group - 11.03% (44/399). The difference in proportions between the study drug and placebo groups was 0.0526 (5.26%), the 95% confidence interval (CI) for the difference in proportions between the groups was [0.0123;0.0937]). More than 94% of single-dose subjects did not become infected with COVID-19 with any symptoms during the 11 days of the follow-up. As a result of a comparative analysis, it was shown that the infection frequency in the study drug group was statistically significantly (almost twice) less than in the comparison group, which indicates a high efficiency and expediency of using the double-stranded sodium salt RNA drug as a means of the post-exposure COVID-19 prophylaxis.Conclusion. Thus, regardless of the vaccination availability, the effectiveness and feasibility of using the study double -stranded sodium salt RNA drug as a means of the post-exposure COVID-19 prophylaxis was demonstrated not only in medical institutions (outpatient clinics and hospitals), but also in caregivers and/or the persons in contact with COVID-19 patients. The situation was the same in the organizations and enterprises in case of evolution of a mass infection threat and the availability of appropriate medical personnels.

Diabetes mellitus in combination with covid-19: Modern views on therapy

Diabetic patients are in the spotlight from the early stages of a pandemic, as growing epidemiological data show they are at higher risk for severe clinical outcomes from COVID-19. As the global COVID-19 pandemic continues to evolve, it is also becoming increasingly apparent that the interactions between COVID-19 and diabetes mellitus (DM) are complex pathophysiological mechanisms. The outcome of COVID-19 is more severe in people with DM, which has the potential to accelerate the onset of acute metabolic complications of DM such as diabetic ketoacidosis and hyperglycemia. These mechanisms underlying these associations remain unclear, but they likely include the angiotensin converting enzyme receptor 2, a binding site for SARS-CoV-2, which is expressed in key metabolic organs such as in the pancreas, in particular in β-cells. The potential β-cell tropism of SARS-CoV-2 can damage cells and impair insulin secretion, causing hyperglycemia and ketoacidosis. Understanding the bidirectional interaction between DM and COVID-19 will be critical to protecting and treating people with DM. Current epidemiological data on COVID-19 do not support the hypothesis that diabetic patients are at increased risk of infection compared to the general population. To date, it has been established that decompensated DM is an independent factor that aggravates the course of coronavirus infection and significantly increases the risk of a fatal outcome of the disease. The review provides a brief summary of the evolution of pathogenetic and clinical aspects for understanding the mechanisms of this pathological tandem, as well as therapeutic strategies for treating patients with COVID-19 and DM. As the incidence of DM continues to rise globally, more than ever, diabetes prevention and control must be a priority for health systems around the world.

Diabetes mellitus and COVID-19: Current issues of pathogenesis, clinic and therapy: Literature review

Currently, due to the rapid spread of COVID-19 with the manifestation of severe acute respiratory syndrome, extensive discussions are underway on a number of topical issues related to the best optimal ways to treat patients with diabetes mellitus (DM) during coronavirus pandemic, including problems of susceptibility to this new infection, presence of comorbid pathology, the disease severity and its course, the risks of complications and mortality, as well as the role of drugs used to control glycemia. The coronavirus pandemic is a severe acute respiratory syndrome SARS-CoV2 (COVID-19) dictates the need for immediate study and deep fundamental understanding of the general pathophysiology of the new disease, potentially determines the choice of therapeutic strategy in patients with DM, affected by coronavirus infection. Currently available epidemiological data on COVID-19 do not support the hypothesis that patients with diabetes are at increased risk of infection compared to the general population. To date, it has been established that decompensated DM is an independent factor that aggravates coronavirus infection and significantly increases the risk of fatal disease outcome. Thus, there are the scientific and clinical needs to obtain new data on the methods of treatment currently used in patients with DM infected with COVID-19 to determine their effectiveness and select the optimal treatment strategy, provide a less severe course and better prognosis of disease. Our knowledge of the new coronavirus infection is deepening day by day and the lessons dealing with this new pandemic around the world are extremely important and very valuable in determining the best approach to fighting against this disease. This review provides a brief summary of the general characteristics of COVID-19, and also based on the literature data provides an analytical characteristics of the relationship between this new infectious disease and DM in order to promote a better understanding of the pathogenetic and clinical aspects of this pathological combination, as well as the selection of the most effective therapeutic strategies for patients with COVID-19 and DM. © 2020 Trylyst. All rights reserved.

Issues of diagnosis and management of patients with neuroendocrine cell hyperplasia of infancy

Neuroendocrine hyperplasia of infancy (NEHI) is an interstitial lung disease (ILD) of unknown etiology, which develops in infancy and manifests as persistent tachypnea. Objective of the research: to summarize results of observations of patients with NEHI, including during the pandemic of a new coronavirus infectious disease (COVID-19). Materials and methods: clinical and follow-up observation, laboratory and instrumental examination, including lung biopsy, 52 children with NEHI aged from 21 days to 10 years. Results: NEHI more often affects boys in the first 6 months of life;can be diagnosed on the basis of pediatric ILD-syndrome detection;specific CT signs, lung biopsy. It is characterized by undulating course with increased respiratory failurec aused by acute respiratory viral infections, COVID-19;half of the patients need oxygen therapy.