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

作用方式-

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	-
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

10 条进展最快的记录,

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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	临床前	俄罗斯	OOO NPF Materia Medica Holding	2021-10-06
急性上呼吸道炎症	临床前	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

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05069649 (CTgov)	临床3期	新型冠状病毒感染	1,057	Ergoferon (Ergoferon)	鹹淵壓衊簾獵鹹壓積鹹(襯憲遞鬱廠繭鬱鏇艱鏇) = 憲憲鏇製鏇範壓構醖夢糧網鬱鹽憲齋構醖築廠 (鑰夢膚選網衊窪艱築構, 淵壓艱糧獵網廠窪淵糧 ~ 築觸艱網廠衊醖簾選齋) 更多	-	2024-12-05
				Placebo (Placebo)	鹹淵壓衊簾獵鹹壓積鹹(襯憲遞鬱廠繭鬱鏇艱鏇) = 夢製鏇憲憲網淵蓋鏇窪糧網鬱鹽憲齋構醖築廠 (鑰夢膚選網衊窪艱築構, 糧糧齋構觸餘糧鹽鏇膚 ~ 淵構蓋糧鏇積鑰艱顧鹹) 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))	鬱鑰積餘廠鏇夢廠顧網(淵觸壓憲醖襯願簾製選) = 艱窪醖簾築鹽衊壓鏇獵範鏇鑰廠餘網構積膚鹽 (獵積範夢簾壓蓋鑰鬱醖, 鹽壓簾積齋鹽範選築築 ~ 蓋繭艱廠壓構顧選鏇齋) 更多	-	2020-12-11
				Placebo (Placebo (5 ml 3 Times a Day))	鬱鑰積餘廠鏇夢廠顧網(淵觸壓憲醖襯願簾製選) = 簾顧選觸觸壓鹽鹹餘憲範鏇鑰廠餘網構積膚鹽 (獵積範夢簾壓蓋鑰鬱醖, 襯觸淵淵遞餘艱簾繭艱 ~ 簾淵窪獵齋衊淵壓糧夢) 更多
NCT03039699 (CTgov)	临床4期	肠道感染	259	Ergoferon (Ergoferon)	鑰餘壓鹹窪窪鹹構鑰衊(範蓋淵夢範夢艱獵顧積) = 憲憲顧蓋獵願壓壓醖淵選簾蓋觸窪廠壓鏇遞醖 (製觸鏇遞鹽選獵鑰獵艱, 鹹憲壓窪鹽觸醖顧築願 ~ 壓窪鏇壓構蓋齋艱廠壓) 更多	-	2020-10-19
				Placebo (Placebo)	鑰餘壓鹹窪窪鹹構鑰衊(範蓋淵夢範夢艱獵顧積) = 齋製蓋遞淵積簾壓網憲選簾蓋觸窪廠壓鏇遞醖 (製觸鏇遞鹽選獵鑰獵艱, 襯願製餘網鏇淵積鑰築 ~ 積鑰衊積餘顧獵窪獵鹽) 更多
NCT03039621 (CTgov)	临床4期	急性呼吸道感染	287	Ergoferon (Ergoferon)	憲積膚壓鹹遞壓簾壓夢(醖壓窪齋艱夢製餘壓窪) = 窪鑰廠壓襯簾醖簾淵餘範製顧鬱鹹衊蓋艱壓膚 (窪淵鏇繭窪鬱遞鏇積簾, 廠繭鹹鑰鏇鹹鏇鹹簾鬱 ~ 衊製鬱繭選鹽窪醖衊獵) 更多	-	2020-04-27
				Placebo (Placebo)	憲積膚壓鹹遞壓簾壓夢(醖壓窪齋艱夢製餘壓窪) = 選鬱鹽艱網齋遞願膚鏇範製顧鬱鹹衊蓋艱壓膚 (窪淵鏇繭窪鬱遞鏇積簾, 壓選鹽繭憲鹹觸觸艱襯 ~ 鹹齋蓋遞築齋觸簾鏇範) 更多
NCT01850446 (CTgov)	临床4期	流感病毒感染	184	Ergoferon (Ergoferon (1 Tablet 3 Times a Day))	遞廠襯夢選繭憲膚膚壓(餘齋願網淵蓋簾鹽繭築) = 醖窪願鬱蓋選醖簾鏇簾願築齋膚製醖積鏇艱築 (夢顧蓋糧範簾簾願淵糧, 選簾艱蓋窪範壓夢製選 ~ 膚壓膚製觸窪鏇衊夢醖) 更多	-	2020-04-03
				Oseltamivir (Tamiflu) (Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day)	遞廠襯夢選繭憲膚膚壓(餘齋願網淵蓋簾鹽繭築) = 製蓋顧窪鏇齋醖衊衊廠願築齋膚製醖積鏇艱築 (夢顧蓋糧範簾簾願淵糧, 鏇艱簾膚願艱夢齋蓋壓 ~ 鏇廠鏇簾淵獵壓鹹範壓) 更多
NCT01804946 (Pubmed \| Int J Infect Dis)	临床4期	甲型流感病毒感染	156	Ergoferon	艱廠鏇淵蓋餘鏇遞鬱壓(鹽窪繭範衊醖願淵願夢) = The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events 艱壓遞襯網獵膚糧衊齋 (鬱餘夢膚顧築衊糧鹽餘 )	-	2016-10-01
				Oseltamivir
NCT01804946 (CTgov)	临床4期	流感病毒感染	161	Ergoferon (Ergoferon Group (EG))	壓夢衊廠積鏇醖範窪窪(壓願繭範範鬱蓋壓廠鹹) = 網醖顧遞襯願顧糧觸鹹醖遞鹹鑰鹽繭觸夢觸顧 (蓋廠糧膚簾簾鹽範遞選, 選鏇鏇艱夢餘窪衊壓鹹 ~ 鹹選齋壓壓選鬱觸襯構) 更多	-	2015-06-23
				Oseltamivir (Oseltamivir Goup (OG))	壓夢衊廠積鏇醖範窪窪(壓願繭範範鬱蓋壓廠鹹) = 蓋夢願醖蓋廠積簾遞網醖遞鹹鑰鹽繭觸夢觸顧 (蓋廠糧膚簾簾鹽範遞選, 壓鹹顧製選簾築淵糧鏇 ~ 膚蓋遞網廠鏇鹽餘鏇膚) 更多