[The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial].

AIM: The search for etiopathogenetic agents to prevent the development of severe and extremely severe COVID-19 remains relevant. A placebo-controlled randomized clinical trial was conducted to evaluate the efficacy and safety of the antibody-based biological drug (Raphamin). MATERIALS AND METHODS: 785 outpatients 18-75 y.o. with laboratory confirmed mild COVID-19 were included within 24 hours from the disease onset. 771 patients were randomized to the group Raphamin (n=382) and the Placebo group (n=389). The study drug/placebo was prescribed for 5 days. The rate of progression to a more severe degree of COVID-19 by day 28 as well as the time to sustained clinical recovery and the frequency of hospitalization were evaluated. Safety was assessed taking into account adverse events, vital signs and laboratory parameters. RESULTS: The number of cases of progression to a more severe degree of COVID-19 in participants receiving Raphamin was 59 (15.5%) [52 (14.6%)] versus placebo - 89 (22.9%) [85 (23.7%)], ITT and [PP] analysis data are presented. The odds ratio between groups was OR=0.6157 [OR=0.5494], 95% confidence interval 0.4276-0.8866 [0.3750-0.8048], which meant a reduction in the chance of progression to a more severe degree by 38.4% [45.1%] or 1.48 [1.62] times; p=0.0088 [p=0.0019]. The time to sustained recovery in the Raphamin group was 4.5±2.4 [4.6±2.4] days, versus placebo - 5.8±4.7 [6.0±4.8] days; p=0.0025 [p=0.0036]. No adverse events with a certain relationship were registered. CONCLUSION: Raphamin reduces the risk of progression to a more severe degree of the COVID-19 and significantly shortens the duration of clinical symptoms.

[Results of an open, randomized, actively controlled study of the efficacy and safety of the new drug Freinozole nasal spray (Phenylephrine + Cetyrizine) in patients with acute respiratory infection]. / Rezul'taty otkrytogo randomizirovannogo aktivno-kontroliruemogo issledovaniia éffektivnosti i bezopasnosti novogo lekarstvennogo preparata Frinozol sprei nazal'nyi (Feniléfrin + Tsetirizin) u patsientov s ostroi respiratornoi infektsiei.

The aim of the study was proof of efficacy and safety of the drug Frinozol nasal spray in patients with acute respiratory infection (acute rhinitis). PATIENTS AND METHODS: A randomized open-label study with active control included 134 ambulatory patients: men and women aged 18 to 65 years with acute upper respiratory tract infection (acute rhinitis) lasting no more than 48 hours before inclusion into the study. Patients were randomized in two groups: group 1 took Frinozol nasal spray 2 sprays per each nostril three times a day for 7 days, subjects randomized to the group 2 took Vibrocil at the same dose and treatment regimen. The primary efficacy endpoint in the study was assessment of the dynamics of symptoms such as nasal congestion, rhinorrhea, itching in the nose and hyposmia using 10 cm VAS in 1 day after the start of treatment compared to the baseline. Secondary endpoints included assessment of the dynamics of nasal symptoms after 7 days of treatment, changes in the values of the Congestion Quantifier 5, CQ-5 questionnaire and evaluation of the effectiveness by the investigator. Safety analysis was carried out throughout the study and included the assessment of adverse events, laboratory data, vital signs, ECG assessment. RESULTS: According to the results of the study and comparative analysis of the primary (assessment of the dynamics of nasal symptoms on a 10 cm visual analogue scale 1 day after the start of treatment) and secondary efficacy endpoints as well as a comprehensive safety analysis, it can be concluded that the study drug is not inferior to the reference drug. Thus, the new combination Frinozol nasal spray is an effective and safe treatment for patients with acute respiratory infections.

[Approaches to the choice of antianginal therapy of elderly patients with stable angina pectoris depending on psycho-emotional status].

The aim of the research was to assess the condition and dynamics of the psychoemotional status in elderly patients with stable angina in different variants of antianginal therapy with beta-blockers or ivabradine. Various dynamics of anginal syndrome depending on the severity of manifestations of a depressive episode was revealed. It is proved that the assessment of the psychological status can appear perspective for differentiated selection of antianginal therapy, since the appointment beta-blockers to patients with a low-depressive syndrome can degrade the performance of depression, whereas the appointment of ivabradin improves the mental condition and can be recommended when identifying a major depressive syndrome.

[Life quality in patients with early hypertensive disease]. / Kachestvo zhizni bol'nykh s nachal'noi stadiei gipertonicheskoi bolezni.

Thirty-seven males aged 18 to 55 years (mean age 29.6 +/- 1.8 years) who had a 1-3-year history of arterial hypertension (AH) were examined. All the patients were found to have grade 1 hypertension. Life quality (LQ) was studied using the questionnaire developed by the Ivanovo State Medical Academy in 2000. A significant decrease in LQ was found at the peak of AH in the patients as compared with healthy individuals; however, the specific parameters of the health status and reductions in their functional capacities differed slightly. It is concluded that it is necessary to apply a standardized approach to assessing the patients' complaints and medical history data.