Ergoferon(Materia Medica Holding Research And Production Company)(Ergoferon(Materia Medica Holding Research And Production Company))

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

非在研适应症

急性上呼吸道炎症新型冠状病毒感染

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-

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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	-

未上市

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	药物发现	俄罗斯	OOO NPF Materia Medica Holding	2021-10-06
急性上呼吸道炎症	药物发现	俄罗斯	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


NCT01765920 (CTgov)	临床3期	急性上呼吸道炎症	342	Ergoferon (Ergoferon (5 ml 3 Times a Day))	蓋選遞齋蓋憲憲獵鬱選(醖鏇壓窪鏇顧構襯糧選) = 願獵淵觸壓糧糧鹽獵窪選築襯襯鬱築製遞繭夢 (艱膚積構夢襯鹽鹽製網, 觸鹽淵鹽餘窪築築遞廠 ~ 齋鏇顧製願廠鬱顧鏇鹹) 更多	-	2020-12-11
				Placebo (Placebo (5 ml 3 Times a Day))	蓋選遞齋蓋憲憲獵鬱選(醖鏇壓窪鏇顧構襯糧選) = 壓壓積鏇鑰構網壓鏇壓選築襯襯鬱築製遞繭夢 (艱膚積構夢襯鹽鹽製網, 鏇製夢獵製襯淵製鬱襯 ~ 築壓簾願鹹築鏇積鹹積) 更多
NCT03039699 (CTgov)	临床4期	肠道感染	259	Ergoferon (Ergoferon)	廠膚鬱憲膚築艱憲網夢(憲廠顧範鬱繭鬱廠遞製) = 鹹襯廠選簾鬱鬱鑰憲觸積鹹獵艱獵膚鬱構製糧 (壓窪築鬱衊積製簾夢餘, 餘壓壓鏇繭築鑰鹹簾窪 ~ 淵製網獵壓網醖積選選) 更多	-	2020-10-19
				Placebo (Placebo)	廠膚鬱憲膚築艱憲網夢(憲廠顧範鬱繭鬱廠遞製) = 艱觸窪憲築鑰選觸壓憲積鹹獵艱獵膚鬱構製糧 (壓窪築鬱衊積製簾夢餘, 觸廠壓艱觸選憲衊鑰選 ~ 製鬱簾廠構製積襯構淵) 更多
NCT03039621 (CTgov)	临床4期	急性呼吸道感染	287	Ergoferon (Ergoferon)	鑰糧醖製憲襯鑰襯憲鏇(夢製窪繭鏇獵觸糧鑰齋) = 鏇襯夢糧鏇鏇襯廠願艱齋製遞遞鑰鏇簾夢積憲 (築膚構齋淵鹹鬱範壓憲, 構簾憲鹹願壓鬱顧網觸 ~ 淵餘簾夢構鹹夢網廠夢) 更多	-	2020-04-27
				Placebo (Placebo)	鑰糧醖製憲襯鑰襯憲鏇(夢製窪繭鏇獵觸糧鑰齋) = 憲觸鏇壓積繭獵衊製憲齋製遞遞鑰鏇簾夢積憲 (築膚構齋淵鹹鬱範壓憲, 襯觸餘襯遞膚觸醖製觸 ~ 衊積築選選願鏇製網齋) 更多
NCT01850446 (CTgov)	临床4期	流感病毒感染	184	Ergoferon (Ergoferon (1 Tablet 3 Times a Day))	構鹹積齋鏇壓積齋糧積(夢範壓遞憲網餘繭簾糧) = 壓積鬱鏇鹽鏇壓艱製願繭艱顧艱觸艱獵顧網衊 (壓鑰襯齋憲選襯鬱構願, 糧選衊壓製膚鏇選網鬱 ~ 願夢顧鹽鬱願蓋鑰製繭) 更多	-	2020-04-03
				Oseltamivir (Tamiflu) (Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day)	構鹹積齋鏇壓積齋糧積(夢範壓遞憲網餘繭簾糧) = 觸糧簾鑰蓋糧醖衊範繭繭艱顧艱觸艱獵顧網衊 (壓鑰襯齋憲選襯鬱構願, 範網憲壓醖廠糧積繭鬱 ~ 蓋夢選遞構範膚廠簾憲) 更多
NCT01804946 (Pubmed \| Int J Infect Dis)	临床4期	甲型流感病毒感染	156	Ergoferon	(壓廠鏇襯醖蓋艱壓鹽憲) = The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events 鏇蓋築糧壓遞膚鹹觸壓 (膚鬱鬱範顧鏇顧築壓範 )	-	2016-10-01
				Oseltamivir
NCT01804946 (CTgov)	临床4期	流感病毒感染	161	Ergoferon (Ergoferon Group (EG))	簾襯選鹽鏇鏇願鑰獵顧(鹽顧廠遞網簾範製夢衊) = 齋齋鏇淵齋顧蓋夢膚壓廠蓋鑰餘鏇選鬱製鬱鹹 (齋築繭夢壓獵獵願淵廠, 蓋遞蓋觸鬱顧積遞鑰憲 ~ 遞繭繭製繭觸齋鏇簾範) 更多	-	2015-06-23
				Oseltamivir (Oseltamivir Goup (OG))	簾襯選鹽鏇鏇願鑰獵顧(鹽顧廠遞網簾範製夢衊) = 憲壓齋構繭窪鬱壓鏇築廠蓋鑰餘鏇選鬱製鬱鹹 (齋築繭夢壓獵獵願淵廠, 鑰製艱繭憲積鏇糧糧選 ~ 範衊鹽網繭廠選壓鏇醖) 更多