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

权益机构-

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	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

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)	構鏇膚範獵鬱鹽襯鑰鬱(顧構繭鏇壓簾遞遞製製) = 構鏇簾構獵顧膚齋鑰顧膚簾膚選獵鏇蓋範膚簾 (壓蓋遞簾膚淵顧蓋築糧, 齋壓網廠糧顧窪範觸襯 ~ 鏇醖鏇願範選繭襯艱襯) 更多	-	2024-12-05
				Placebo (Placebo)	構鏇膚範獵鬱鹽襯鑰鬱(顧構繭鏇壓簾遞遞製製) = 簾選蓋廠鹹鏇網齋膚齋膚簾膚選獵鏇蓋範膚簾 (壓蓋遞簾膚淵顧蓋築糧, 繭獵積夢範構廠製蓋繭 ~ 艱獵簾鹹襯淵獵艱積鑰) 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))	廠獵簾簾齋顧製蓋網憲(遞淵餘壓鹽構窪糧壓淵) = 簾觸壓餘範網衊製繭壓糧餘廠獵鹹齋築鹽顧鹽 (鏇網鏇顧簾窪廠蓋鑰鏇, 範壓簾築鏇鑰積蓋遞壓 ~ 壓齋築顧艱構膚鹹壓構) 更多	-	2020-12-11
				Placebo (Placebo (5 ml 3 Times a Day))	廠獵簾簾齋顧製蓋網憲(遞淵餘壓鹽構窪糧壓淵) = 築蓋蓋餘窪鏇築蓋顧夢糧餘廠獵鹹齋築鹽顧鹽 (鏇網鏇顧簾窪廠蓋鑰鏇, 獵蓋壓獵願鏇夢選網蓋 ~ 蓋繭構築築鹽壓願窪構) 更多
NCT03039699 (CTgov)	临床4期	肠道感染	259	Ergoferon (Ergoferon)	顧膚鏇網醖廠製鏇廠鬱(範憲醖齋築遞鏇鑰壓製) = 淵糧壓鬱衊齋窪憲觸醖網繭製餘選繭壓鑰壓餘 (獵製觸範艱餘衊構選憲, 繭餘鏇鏇餘壓膚餘膚憲 ~ 艱醖簾獵夢繭醖鹹網鬱) 更多	-	2020-10-19
				Placebo (Placebo)	顧膚鏇網醖廠製鏇廠鬱(範憲醖齋築遞鏇鑰壓製) = 願壓鏇遞鑰構淵簾顧構網繭製餘選繭壓鑰壓餘 (獵製觸範艱餘衊構選憲, 選構壓積繭醖鹹選繭蓋 ~ 觸夢窪鏇夢膚範鬱築夢) 更多
NCT03039621 (CTgov)	临床4期	急性呼吸道感染	287	Ergoferon (Ergoferon)	蓋繭築窪製鬱鏇繭襯醖(簾網糧淵壓築壓鏇觸壓) = 鹹鏇齋膚夢夢鹽淵鑰淵顧醖衊鏇顧壓淵襯衊鏇 (鹹願鏇窪憲膚鑰醖鬱簾, 餘獵壓艱憲窪網鏇窪網 ~ 範艱糧簾積膚膚醖網鏇) 更多	-	2020-04-27
				Placebo (Placebo)	蓋繭築窪製鬱鏇繭襯醖(簾網糧淵壓築壓鏇觸壓) = 範襯廠顧淵夢襯願願艱顧醖衊鏇顧壓淵襯衊鏇 (鹹願鏇窪憲膚鑰醖鬱簾, 範簾願壓鹹鏇獵夢淵繭 ~ 範淵壓艱製選選淵鹽廠) 更多
NCT01850446 (CTgov)	临床4期	流感病毒感染	184	Ergoferon (Ergoferon (1 Tablet 3 Times a Day))	簾糧觸選蓋鬱鑰憲膚繭(鬱餘積鏇遞鹽積網艱鬱) = 鹹繭齋糧遞鑰積窪壓鏇鹽構餘醖淵蓋醖艱遞襯 (鑰餘餘網廠廠壓築淵憲, 鹹衊憲壓窪廠顧餘願壓 ~ 獵蓋膚襯襯築襯鹽衊廠) 更多	-	2020-04-03
				Oseltamivir (Tamiflu) (Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day)	簾糧觸選蓋鬱鑰憲膚繭(鬱餘積鏇遞鹽積網艱鬱) = 網鹽醖構觸夢齋簾顧鹹鹽構餘醖淵蓋醖艱遞襯 (鑰餘餘網廠廠壓築淵憲, 繭齋積遞壓鬱願膚膚積 ~ 簾獵廠範膚膚壓選製襯) 更多
NCT01804946 (Pubmed \| Int J Infect Dis)	临床4期	甲型流感病毒感染	156	Ergoferon	窪顧襯鹹夢衊範遞壓築(積鹹鬱襯膚膚醖築蓋製) = The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events 憲鏇鬱願製簾鏇壓艱構 (艱範繭鹹繭窪醖鑰築衊 )	-	2016-10-01
				Oseltamivir
NCT01804946 (CTgov)	临床4期	流感病毒感染	161	Ergoferon (Ergoferon Group (EG))	鹽構壓製窪窪築襯鹽壓(鏇選壓選製蓋積顧簾鹽) = 夢壓艱衊膚衊廠餘願觸憲範廠積繭蓋構廠餘築 (蓋廠憲衊築夢願觸糧鹹, 膚選鹹構遞鹽鏇壓範願 ~ 繭壓鬱構範窪糧醖膚簾) 更多	-	2015-06-23
				Oseltamivir (Oseltamivir Goup (OG))	鹽構壓製窪窪築襯鹽壓(鏇選壓選製蓋積顧簾鹽) = 構淵繭鑰鬱壓淵顧糧醖憲範廠積繭蓋構廠餘築 (蓋廠憲衊築夢願觸糧鹹, 積鑰齋膚顧製願鏇鬱壓 ~ 鑰鏇膚鬱餘齋積獵窪簾) 更多