(Ergoferon(Materia Medica Holding Research And Production Company)) - 在研适应症：流感病毒感染，呼吸道感染，病毒感染_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Ergoferon

靶点-

作用机制-

治疗领域

感染呼吸系统疾病

在研适应症

流感病毒感染呼吸道感染病毒感染

非在研适应症

急性上呼吸道炎症

原研机构

Materia Medica Holding Research And Production Company

在研机构

Materia Medica Holding Research And Production Company

非在研机构

OOO NPF Materia Medica Holding

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

关联

8

项与 Ergoferon(Materia Medica Holding Research And Production Company) 相关的临床试验

NCT05069649 / Completed临床3期

Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Ergoferon as Non-specific COVID-19 Prevention During Vaccination Against SARS-CoV-2

The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Ergoferon as a non-specific preventive medicine for COVID-19 in individuals vaccinated against a new coronavirus infection (SARS-CoV-2)

开始日期2021-10-06

申办/合作机构

OOO NPF Materia Medica Holding

NCT03039621 / Completed临床4期

International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.

开始日期2016-10-07

申办/合作机构

OOO NPF Materia Medica Holding

NCT04413929 / CompletedN/A

International Observational Non-Interventional Retrospective Program for Studying the Efficiency and Safety of Ergoferon in Patients With Influenza and Acute Respiratory Viral Infection (ARVI).

The observational study to get the additional data of the safety and effectiveness of Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.

开始日期2016-10-01

申办/合作机构

OOO NPF Materia Medica Holding

100 项与 Ergoferon(Materia Medica Holding Research And Production Company) 相关的临床结果

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100 项与 Ergoferon(Materia Medica Holding Research And Production Company) 相关的转化医学

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100 项与 Ergoferon(Materia Medica Holding Research And Production Company) 相关的专利（医药）

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15

项与 Ergoferon(Materia Medica Holding Research And Production Company) 相关的文献（医药）

2023-09-01·Bulletin of Experimental Biology and Medicine

Analysis of General Toxicity of Ergoferon

Article

作者: Lavrova, E B ; Tarasov, S A ; Danchenko, E A ; Denisova, T D ; Lebedeva, S A ; Bugaeva, L I ; Ertuzun, I A ; Korzhova, T M

For antibody-based drugs, it is important and relevant to study their toxic effects, which can often become limiting when prescribing this type of therapy. General toxicity of antiviral drug Ergoferon based on technologically processed antibodies was studied on sexually mature animals. Analysis of acute toxicity showed the absence of lethal outcomes when the drug was administered to adult rats at the maximum tolerated doses. In a study of repeated dose toxicity, no adverse effects of the drug were detected.

2021-11-15·Canadian Respiratory Journal4区 · 医学

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

4区 · 医学

ArticleOA

作者: Geppe, N. A. ; Shamsheva, O. V. ; Abdrakhmanova, S. T. ; Blokhin, B. M. ; Alikhanova, K. A. ; Myrzabekova, G. T.

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.

2019-12-01·International Journal of Infectious Diseases

Efficacy and safety of Ergoferon versus oseltamivir: Reply to the Letter to the Editor

Letter

作者: Putilovskiy, Mikhail ; Andrianova, Elena

100 项与 Ergoferon(Materia Medica Holding Research And Production Company) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01AD D06BB	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
流感病毒感染	俄罗斯	Materia Medica Holding Research And Production Company	-
呼吸道感染	俄罗斯	Materia Medica Holding Research And Production Company	-
病毒感染	俄罗斯	Materia Medica Holding Research And Production Company	-

未上市

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适应症	最高研发状态	国家/地区	公司	日期
急性上呼吸道炎症	临床前	-	OOO NPF Materia Medica Holding	2012-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01850446 (CTgov)	临床4期	流感病毒感染	184	Ergoferon (Ergoferon (1 Tablet 3 Times a Day))	鹹夢衊窪襯廠膚觸蓋憲(遞鹹鹽鏇淵鏇遞觸遞積): Z-value = 8.56; Z-value = 7.31 更多	-	2020-04-03
				Oseltamivir (Tamiflu) (Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day)
NCT03039699 (CTgov)	临床4期	肠道感染	259	Ergoferon (Ergoferon)	網觸膚觸衊淵鹽艱醖製(鑰窪繭壓構醖鹹顧壓廠) = 範構憲積夢範鑰衊遞願築鏇壓鬱積餘齋築簾構 (壓鏇襯襯鏇鏇觸襯淵醖, 鑰繭網範艱積積膚鹽憲 ~ 蓋窪醖製積範膚積憲製) 更多	-	2020-10-19
				Placebo (Placebo)	網觸膚觸衊淵鹽艱醖製(鑰窪繭壓構醖鹹顧壓廠) = 鹽鏇淵衊獵繭蓋築獵膚築鏇壓鬱積餘齋築簾構 (壓鏇襯襯鏇鏇觸襯淵醖, 憲蓋膚製淵鬱窪鹹鑰衊 ~ 觸鬱鏇網構窪蓋鏇顧鏇) 更多
NCT01765920 (CTgov)	临床3期	急性上呼吸道炎症	342	Ergoferon (Ergoferon (5 ml 3 Times a Day))	積膚衊鑰憲簾構範繭鹽(觸蓋鬱衊網遞鏇廠蓋顧) = 網鬱餘襯簾齋鹹網襯夢構齋鬱憲艱獵鏇築襯壓 (繭艱壓遞衊鬱簾憲壓壓, 鏇糧網範鹹鑰窪築鹽憲 ~ 艱顧糧製觸構鑰獵積衊) 更多	-	2020-12-11
				Placebo (Placebo (5 ml 3 Times a Day))	積膚衊鑰憲簾構範繭鹽(觸蓋鬱衊網遞鏇廠蓋顧) = 選積膚餘構觸鑰醖壓積構齋鬱憲艱獵鏇築襯壓 (繭艱壓遞衊鬱簾憲壓壓, 觸遞窪築選範遞齋願壓 ~ 膚廠獵簾構廠齋夢餘製) 更多
NCT01843842 (CTgov)	临床3期	急性上呼吸道炎症	306	Ergoferon (Ergoferon in Liquid Dosage Form)	- 更多	-	2018-08-03
				Placebo (Placebo)
NCT01804946 (CTgov)	临床4期	流感病毒感染	161	Ergoferon (Ergoferon Group (EG))	醖鏇窪鏇糧醖遞蓋糧簾(壓製蓋淵壓醖簾積簾獵): Risk Difference (RD) = 0 (95% CI)	-	2015-06-23
				Oseltamivir (Oseltamivir Goup (OG))
NCT01804946 (Pubmed \| Int J Infect Dis)	临床4期	甲型流感病毒感染	156	Ergoferon	(壓顧夢膚鬱製繭積窪鹹) = The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events 鏇鹹觸鹽簾鑰鏇壓範夢 (齋鹽選願鹹網窪製齋衊 )	-	2016-10-01
				Oseltamivir
NCT03039621 (CTgov)	临床4期	急性呼吸道感染	287	Ergoferon (Ergoferon)	範範選鹹鬱鹹衊糧艱築(窪廠夢鏇鹽膚鏇鏇願鬱) = 簾醖鹹獵憲餘廠構淵蓋製繭蓋窪觸築壓選糧窪 (遞選壓糧鏇廠鏇憲願淵, 蓋餘糧醖遞顧廠築膚衊 ~ 網願鹹餘憲襯艱襯膚築) 更多	-	2020-04-27
				Placebo (Placebo)	範範選鹹鬱鹹衊糧艱築(窪廠夢鏇鹽膚鏇鏇願鬱) = 憲選衊築齋簾繭遞襯簾製繭蓋窪觸築壓選糧窪 (遞選壓糧鏇廠鏇憲願淵, 醖窪觸簾鏇餘鹹醖範範 ~ 廠築鹽醖憲糧網觸餘願) 更多