Release-Active Antiviral Drug Ergoferon in Treatment of Acute Respiratory Infections in Children. The Efficacy of the Liquid Dosage Form of Ergoferon: Results of a Randomized, Double-Blind, Placebo-Controlled Clinical Research

Геппе, Н.А.; Кондюрина, Е. Г.; Мельникова, И. М.; Sabitov, A.U.; Перминова, О. А.; Galustyan, A.N.; Pak, Theresa; Kamaev, A.V.; Laleko, S.L.; Zhiglinskaya, O.V.; Лазарева, С. Г.; Bultserovich, N.B.

doi:10.24110/0031-403x-2019-98-1-87-94

Cited by 6 publications

(4 citation statements)

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“…Rengalin, the drug based on APTP Abs to bradykinin, histamine, and morphine, has demonstrated therapeutic efficacy in treating cough in children with ARVI. Rengalin reduces the severity and duration of cough, has an anti-inflammatory and anti-edematous effect, and also reduces the irritation of the bronchial mucosa and afferent impulses that trigger a cough reflex, and improves the drainage function of the bronchi, and sputum discharge [93,94].…”

Section: Antitussivesmentioning

confidence: 99%

The Common Cold and Influenza in Children: To Treat or Not to Treat?

et al. 2023

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The common cold, which is mostly caused by respiratory viruses and clinically represented by the symptoms of acute respiratory viral infections (ARVI) with mainly upper respiratory tract involvement, is an important problem in pediatric practice. Due to the high prevalence, socio-economic burden, and lack of effective prevention measures (except for influenza and, partially, RSV infection), ARVI require strong medical attention. The purpose of this descriptive literature review was to analyze the current practical approaches to the treatment of ARVI to facilitate the choice of therapy in routine practice. This descriptive overview includes information on the causative agents of ARVI. Special attention is paid to the role of interferon gamma as a cytokine with antiviral and immunomodulatory effects on the pathogenesis of ARVI. Modern approaches to the treatment of ARVI, including antiviral, pathogenesis-directed and symptomatic therapy are presented. The emphasis is on the use of antibody-based drugs in the immunoprophylaxis and immunotherapy of ARVI. The data presented in this review allow us to conclude that a modern, balanced and evidence-based approach to the choice of ARVI treatment in children should be used in clinical practice. The published results of clinical trials and systematic reviews with meta-analyses of ARVI in children allow us to conclude that it is possible and expedient to use broad-spectrum antiviral drugs in complex therapy. This approach can provide an adequate response of the child’s immune system to the virus without limiting the clinical possibilities of using only symptomatic therapy.

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Section: Antitussivesmentioning

confidence: 99%

The Common Cold and Influenza in Children: To Treat or Not to Treat?

et al. 2023

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“…From day 2 through 5, a tablet was administered three times daily. e efficacy and safety of this specific drug regimen have been assessed and proven in previous RCTs [25][26][27][28][29][30][31][32][33][34][35].…”

Section: Treatmentmentioning

confidence: 99%

“…A range of randomized controlled trials (RCTs) have shown the efficacy and safety of Ergoferon in the treatment of adult and children with influenza and vARIs [20][21][22][23][24][25][26][27][28][29][30].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Ergoferon in Children from 6 Months to 6 Years Old with Acute Respiratory Viral Infections in Contemporary Outpatient Practice: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial

Геппе

Блохин

Шамшева³

et al. 2021

Canadian Respiratory Journal

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To evaluate the efficacy and safety of Ergoferon in combination with symptomatic therapy in children from 6 months to 6 years old with acute respiratory infections (ARI) in contemporary outpatient practice, an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial was performed. Derived by technological treatment of antibodies to interferon gamma, histamine, and CD4, Ergoferon was previously proved to modulate its molecular targets promoting effective antiviral protection. The data of 282 patients with oral temperature ≥38.0°C plus mild to moderate severity of flu-like nonspecific and nasal/throat/chest symptoms were included in intention-to-treat analysis (n = 140, Ergoferon group; n = 142, placebo group). Time to alleviation of all ARI symptoms was the primary endpoint, and 8 outcome measures were estimated as the secondary endpoints. Respiratory viruses were confirmed in 57.1% (Ergoferon) and 54.9% (Placebo) of patients. Compared to placebo, Ergoferon reduced time to alleviation of all ARI symptoms (4.5 ± 1.7 versus 5.2 ± 2.2 days in placebo; p = 0.026 ) including fever (2.8 ± 1.5 vs 3.4 ± 2.0; p = 0.031 ), flu-like nonspecific (4.0 ± 1.8 vs 4.7 ± 2.2, p = 0.022 ), and nasal/throat/chest (4.3 ± 2.0 versus 5.0 ± 2.3; p = 0.024 ) symptoms. Ergoferon add-on therapy decreased the mean total symptom severity score (according to 4-point scale for each symptom), ARI severity, frequency of antipyretic use, and percentage of complication requiring antibiotics and increased the percentage of recovered patients. The incidence of adverse events (AEs) in the Ergoferon group was significantly lower compared to the placebo group (7.0% versus 18.8%; p = 0.004 ) including infectious diseases (3.5% vs 12.5%; p = 0.008 ). In the Ergoferon group, AEs were mild or moderate. In 8 (57.1%) cases, AEs were unrelated to Ergoferon, in 5 (35.7%), the relationship was uncertain, and in 1 (7.1%), it was possible (mild rash on the face). Ergoferon treatment is beneficial for infants and young children with ARI in contemporary outpatient practice. Being well-tolerated, Ergoferon increases the symptomatic therapy effectiveness and improves the patient condition and disease outcomes.

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“…The active pharmaceutical ingredients (released-active dilutions of antibodies) are produced by GMP manufacturing facilities in Russia. Clinical studies on Ergoferon (Anon, 2019b,c;Sel'kova et al, 2019;Geppe et al, 2019;Kondyurina et al, 2016a,b), as well as other released-active drugs (Anon, 2019d,e), have been conducted in accordance with GCP and they are controlled by the Ministry of Health of the Russian Federation. Detailed information about the drug Ergoferon is available on the official website of the Ministry of Health (Anon, 2019f).…”

mentioning

confidence: 99%