[Evaluation of the efficacy and safety of a complex antiviral drug based on antibodies in the treatment of adult patients with acute respiratory viral infection].

AIM: To evaluate the efficacy and safety of Raphamin, containing technologically processed affinity-purified antibodies to interferon , CD4 receptor, 1 domain of the major histocompatibility complex class II and 2 microglobulin major histocompatibility complex class I in the treatment of acute respiratory viral infection (ARVI), including influenza, in adults. MATERIALS AND METHODS: 240 patients 1870 years old with ARVI were included in a phase III (20192020), randomized, double-blind, placebo-controlled trial. Pregnant women, patients with suspected bacterial infections were excluded from the study. Raphamin/placebo was prescribed for 5 days within 24 hours of the illness onset. Primary endpoint was a time to resolution of ARVI (Polymerase chain reaction PCR-confirmed). Additionally, the severity of ARVI, proportion of patients with ARVI resolution/worsening/complications, frequency of antipyretics prescription, and time to resolution of symptoms of ARVI (including PCR non confirmed) were assessed. RESULTS: The average time to resolution of ARVI (PCR-confirmed) was 4.11.9 [4.01.9] and 5.02.5 [5.02.5] days in the Raphamin/placebo groups (ITT and [PP] analysis, р=0.0155 and [р=0.0114], respectively). The duration of ARVI decreased by 0.892.23 [0.932.25] days. Superiority of Raphamin was shown during therapy period according to the ARVI resolution criterion (р=0.0014 [р=0.0005]). There were no statistically significant difference in the severity of ARVI and frequency of antipyretics prescription. The proportion of patients with worsening/complications was 0 [0]% and 2.5 [2.8]% in the Raphamin and placebo groups, respectively. Favorable safety profile of Raphamin (including the incidence and severity of adverse events) and high compliance were shown. CONCLUSION: Raphamin promotes significant decrease, practically by a day, the duration of ARVI, including influenza.

[Non-specific prevention of COVID-19 during vaccination against a new coronavirus infection: results of a multicenter, double-blind, placebo-controlled, randomized clinical trial].

BACKGROUND: A multicenter, double-blind, placebo-controlled, randomized clinical trial (RCT) of the phase III efficacy and safety of Ergoferon® for the non-specific prevention of COVID-19 during vaccination against a new coronavirus infection was conducted (permission of the Ministry of Health of the Russian Federation №559 dated 22.09.2021; ClinicalTrials.gov Identifier: NCT05069649). AIM: To evaluate the efficacy and safety of the use of Ergoferon for the non-specific prevention of COVID-19 during vaccination against a new coronavirus infection. MATERIALS AND METHODS: From October 2021 to April 2022, 1,057 patients aged 18 to 92 years who received component I of the "Gam-COVID-Vac" vaccine were included. After screening, 1,050 patients were randomized into 2 groups: 526 people received Ergoferon according to the prophylactic scheme - 1 tablet per administration 2 times a day for 3 weeks, the drug is not allowed during the meal and should be kept in the mouth without swallowing, until completely dissolved; 524 patients received a placebo according to the Ergoferon® scheme. The total duration of participation in the study was 5 weeks + 3 days. The primary endpoint is the number of RT-PCR - confirmed cases of SARS-CoV-2 infection, regardless of the presence of symptoms during participation in the study. An additional criterion of effectiveness is the proportion of those hospitalized with COVID-19. The safety assessment included consideration of the presence and nature of adverse events (AEs), their severity, relationship with the drug intake, and outcome. Statistical data processing was carried out using SAS 9.4 with the calculation of the exact Fisher test, χ2 test, Cochrane-Mantel-Hensel test, Wilcoxon test and other parameters. RESULTS: The ITT (Intention-to-treat) and PP [Per Protocol] efficacy analysis included data from 1,050 [970] patients: 526 [489] people - Ergoferon® group and 524 [481] people - Placebo group. The primary endpoint - the number of laboratory-confirmed cases of SARS-CoV-2 infections was 3 times less compared to placebo - 7 (1.43%) vs 22 (4.57%), respectively (p=0.0046; [p=0.0041]). Taking Ergoferon® reduces the risk of SARS-CoV-2 infection by more than 3 times in vaccinated patients during 5 weeks of the vaccination and post-vaccination periods (p=0.0046 [p=0.0041]). Of the COVID-19 patients in the Ergoferon® group (1.33%) nobody was hospitalized. According to the Post hoc analysis, Ergoferon® reduces the risk of COVID-19 disease by 4 times in the period between the components I and II of the "Gam-COVID-Vac" vaccine (p=0.0066 [p=0.006]). The frequency of AEs in both groups did not differ. There were no registered AEs associated with the drug with a reliable degree. There was a high level of patient compliance and good tolerability. CONCLUSION: Ergoferon is an effective and safe drug for the prevention of COVID-19 in people vaccinated against a new coronavirus infection.

[The history of the Kazan School of Therapists (on the occasion of the 200th anniversary of the Kazan State Medical University)].

The history of the Kazan School of Therapists numbers two centuries of scientific achievements and discoveries. German Professors F.H. Erdman and K.F. Fuks laid the groundwork for clinical teaching continued by Russian therapists N.A. Skandovsky, N.A. Vinogradov, A.P. Kazem-Bek, N.K. Goryaev, and other distinguished scientists. The prominent scientists of the 20th century made great contributions to the development of modern therapy; the names of M.N. Cheboksarov, Z.I. Malkin, A.G. Teregulov, and I.G. Salikhov are known and they are respected by the world medical public.

[Significance of antibacterial therapy of Chlamydophila pneumoniae infection in patients with bronchial asthma]. / Znachenie antibakterial'noi terapii pri Chlamydophila pneumomiae infektsii u bol'nykh bronkhial'noi astmoi.

AIM: To study effects of eradication of Chlamydophila pneumoniae CP) infection in bronchial asthma (BA) on BA course and changes in quality of life (QOL) in BA patients. MATERIAL AND METHODS: 194 BA patients in clinical remission participated in the trial. Microbiological diagnosis of asymptomatic CP infection was made serologically (ELISA, indirect enzyme immunoassay) using polymerase chain reaction. Clinical and biochemical tests, assessment of pulmonary ventilation function, QOL by AQLQ during 6-week antimicrobial therapy were made in 56 patients. RESULTS: Patients with stable BA had high frequency of serological signs of clinically asymptomatic CP infection (52%) deteriorating BA symptoms and QOL. Antibacterial therapy of latent CP infection with azitromycin significantly improved BA course and QOL of BA patients. CONCLUSION: When laboratory tests detect CP infection in patients with long-term course of BA, especially in smoking males with moderate and severe BA it is clinically valid to prescribe addition of azitromycin to basic antiinflammatory treatment of BA.