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1.
Farmatsiya i Farmakologiya ; 10(6):573-588, 2022.
Article in English | EMBASE | ID: covidwho-2251079

ABSTRACT

Currently, there are data that that make it possible to speak about a high clinical efficacy of the use of succinic salt of tyrosylD-alanyl-glycyl-phenylalanyl-leucyl-arginine (hexapeptide succinate) for the COVID-19 treatment. This article is devoted to the results of clinical trials of the original Russian drug based on it. The aim of the study was to evaluate a clinical efficacy, safety and tolerability of intramuscular and inhalation use of hexapeptide succinate in complex therapy in comparison with standard therapy in patients with moderate COVID-19. Materials and methods. The research was conducted from February 28, 2022 to November 22, 2022 based on 10 research centers in the Russian Federation. The study included hospitalized patients (n=312) over 18 years of age with moderate COVID-19 who had undergone a screening procedure and were randomized into 3 groups: group 1 received standard therapy in accordance with the Interim Guidelines in force at the time of the study, within 10 days;group 2 received hexapeptide succinate (Ambervin Pulmo) intramuscularly at the dose of 1 mg once a day for 10 days;group 3 received hexapeptide succinate (Ambervin Pulmo) 10 mg once a day by inhalation for 10 days. Results. According to the results of the study, therapy with the drug hexapeptide succinate, both intramuscular and inhaled, provided an acceleration of recovery up to the complete absence of the disease signs in more than 80% of hospitalized COVID-19 patients. By the end of the therapy course with the drug, more than 60% of patients had met the criteria for discharge from hospital and could continue the treatment on an outpatient basis. About 70% of patients in the inhalation group and 80% in the intramuscular hexapeptide succinate injection group had concomitant diseases (hypertension - 28%, obesity - 14%), which indicates the effectiveness of this drug use in comorbid patients. The use of the drug contributed to the restoration of damaged lung tissues, normalization of oxygenation, the disappearance of shortness of breath and a decrease in the duration of the disease symptoms compared with standard therapy. As a result of a comparative analysis of adverse events in terms of their presence, severity, causal relationship with the therapy and outcome, there were no statistically significant differences between the treatment groups. Conclusion. Thus, the results of the clinical study of the succinate hexapeptide efficacy and safety showed the feasibility of using the drug in pathogenetic therapy COVID-19 regimens.Copyright © 2022 Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute. All rights reserved.

2.
Farmatsiya i Farmakologiya ; 10(5):460-471, 2022.
Article in English | EMBASE | ID: covidwho-2217826

ABSTRACT

The aim of the article is to study pharmacokinetic characteristics of intravenous olokizumab in patients with moderate COVID-19 to relieve a hyperinflammation syndrome. Materials and methods. The pharmacokinetic study was conducted as a part of a phase III clinical study (RESET, NCT05187793) on the efficacy and safety of a new olokizumab regimen (intravenous, at the doses of 128 mg or 256 mg) in COVID-19 patients. Plasma concentrations of olokizumab were determined by the enzyme immunoassay. The population analysis was performed using a previously developed pharmacokinetic model based on a linear two compartment. Results. The pharmacokinetic analysis included the data from 8 moderate COVID-19 patients who had been administrated with olokizumab intravenously at the dose of 128 mg. According to the analysis results in this population, there was an increase in the drug clearance, compared with the data obtained in healthy volunteers and the patients with rheumatoid arthritis: 0.435, 0.178 and 0.147 l/day, respectively. The parameters analysis within the framework of a population pharmacokinetic model showed that the main factors for the increased olokizumab clearance are a high body mass index. In addition, the presence of COVID-19 itself is an independent factor in increasing the drug clearance. Conclusion. After the intravenous olokizumab administration, an increase in the drug clearance is observed in moderate COVID-19 patients against the background of the disease course. The main contribution to the increased clearance is made by the characteristics of the population of COVID-19 patients associated with the risk of a severe disease and inflammation. When administered intravenously at the dose of 128 mg, a therapeutically significant olokizumab level was maintained throughout the acute disease phase for 28 days. Copyright © 2022 Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute. All rights reserved.

3.
Pulmonologiya ; 32(4):548-557, 2022.
Article in Russian | Scopus | ID: covidwho-2056655

ABSTRACT

Cough is one of the most common symptoms of COVID-19 (COronaVIrus Disease-2019), occurring in more than 70% of cases. The cough associated with the new coronavirus infection tends to be non-productive and requires symptomatic antitussive therapy. However, at present, there is insufficient data on the effectiveness of various antitussive agents in COVID-19. The aim. Analysis of the clinical and economic efficiency and safety of the use of levodropropizin in comparison with standard symptomatic therapy of patients with a new coronavirus infection COVID-19 in the real-life clinical setting. Methods. An open observational multicenter study was conducted in Moscow, Krasnodar, Kazan, Voronezh, and Rostov-on-Don. The study enrolled 250 inpatient COVID 19 patients (1 875 years) with complaints of dry unproductive cough which required symptomatic treatment. The main group included 150 people who received levodropropizine according to the label. The comparison group received other antitussive drugs. Each patient was examined on days 1, 4 and 8. The examination included collection of the current complaints and medical history, physical examination and assessment of the intensity of cough using day and night cough assessment scale using a 6-point scale for assessing daytime and nighttime cough and a visual analog scale (VAS). Results. In the main group, significant differences were revealed between the baseline and Day 4 in the form of a significant decrease in the severity of daytime cough (р = 0.002);significant differences were found between Day 4 and Day 8 for both daytime (р = 0.002) and nocturnal cough (р = 0.0001). The comparison group showed positive dynamics, but significant differences were seen only between the baseline and Day 8 at night (р = 0.001). The severity of cough on VAS scale in the main group differed significantly on Day 8 as compared to baseline (р = 0.001), as well as between Day 4 and Day 8 (р = 0.002). No significant differences were seen in the comparison group. No adverse effects were observed during treatment with levodropropizine. Conclusion. Levodropropizine has shown high efficacy and safety in the treatment of dry unproductive cough in comparison with standard symptomatic therapy in the form of a significant decrease in cough intensity according to both scales, starting from the 4th day. © 2022 Medical Education. All rights reserved.

4.
American Journal of Translational Research ; 13(11):12575-12587, 2021.
Article in English | EMBASE | ID: covidwho-1567690

ABSTRACT

Favipiravir has demonstrated efficacy against the SARS-CoV-2 virus in several preliminary studies. This study aimed to evaluate the efficacy and safety of favipiravir for treatment of mild to moderate COVID-19 in outpatients and hospitalized patients. We conducted an open-label, randomized, active-controlled trial of a generic form of favipiravir in patients with COVID-19 confirmed by PCR-test. Eligible patients (18-60 years) after stratification were randomly assigned (in a 2:1 ratio) to receive either favipiravir (1800 mg BID on day 1, followed by 800 mg BID for up to 9 days), or standard of care (SOC) treatment (umifenovir + intranasal interferon alpha-2b, or hydroxychloroquine) for up to 10 days. The co-primary outcomes were the time to clinical improvement and the time to viral clearance. Among 190 patients assessed for eligibility 168 were randomized to favipiravir (n=112) or to SOC (n=56) group. The median time to clinical improvement was 6.0 days (IQR 4.0;9.3) in the favipiravir group and 10.0 (IQR 5.0;21.0) days in the SOC group;the median difference was 4 days (HR 1.63;95% CI 1.14-2.34;P=0.007). The statistically significant difference in the median time to viral clearance was observed only for hospitalized patients: 3.0 (IQR 3.0;3.0) days in the favipiravir group vs. 5.0 (IQR 4.5;5.5) days in the SOC group (HR 2.11;95% CI 1.04-4.31;P=0.038). The rate of viral elimination on Day 5 in the favipiravir group was significantly higher than in SOC group: 81.2% vs. 67.9% (RR 1.22;05% CI 1.00-1.48;P=0.022). The rate of clinical improvement on Day 7 in the favipiravir group was 1.5-fold higher than in SOC group: 52.7% vs. 35.8% (RR 1.50;95% CI 1.02-2.22;P=0.020). Favipiravir was well-tolerated and the most common adverse reactions were asymptomatic hyperuricemia, transient elevation of ALT & AST, and mild gastrointestinal disorders. Favipiravir was superior to the SOC in shortening the time to clinical improvement in patients with mild to moderate COVID-19.

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