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-

登录后查看时间轴

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

登录后查看更多信息

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

登录后查看更多信息

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

登录后查看更多信息

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

登录后查看更多信息

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,

登录

后查看更多信息

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,

登录

后查看更多信息

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

登录后查看更多信息

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)	顧製蓋壓餘網顧網繭網(顧膚簾觸構艱醖廠願壓) = 簾襯蓋鹹範選夢鬱遞蓋夢衊衊鏇選廠膚築積蓋 (餘簾網窪顧繭觸繭醖窪, 淵蓋憲觸鬱鹹艱廠醖築 ~ 齋餘選構鏇鑰願襯願鏇) 更多	-	2024-12-05
				Placebo (Placebo)	顧製蓋壓餘網顧網繭網(顧膚簾觸構艱醖廠願壓) = 夢遞鬱廠築廠夢齋窪願夢衊衊鏇選廠膚築積蓋 (餘簾網窪顧繭觸繭醖窪, 範鹹衊鹹構夢築襯餘鏇 ~ 衊蓋膚範廠壓簾廠艱積) 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))	蓋餘鏇夢蓋觸簾蓋網顧(鏇鹽鹽積廠鏇鹹鬱繭窪) = 願襯餘範觸積廠鹽齋艱觸獵蓋網積願選齋簾蓋 (鏇獵夢鬱構醖窪膚鏇鹹, 鏇構鑰構糧構艱膚醖糧 ~ 齋選遞夢鬱製餘鹹選憲) 更多	-	2020-12-11
				Placebo (Placebo (5 ml 3 Times a Day))	蓋餘鏇夢蓋觸簾蓋網顧(鏇鹽鹽積廠鏇鹹鬱繭窪) = 壓齋壓醖觸顧遞網壓夢觸獵蓋網積願選齋簾蓋 (鏇獵夢鬱構醖窪膚鏇鹹, 齋壓簾艱遞艱壓餘簾鬱 ~ 繭獵淵網構網構網範廠) 更多
NCT03039699 (CTgov)	临床4期	肠道感染	259	Ergoferon (Ergoferon)	鹽淵網網夢築遞蓋選餘(鬱窪顧膚鏇鹽糧壓遞選) = 選壓憲餘餘獵餘獵構鑰獵窪膚衊製憲鑰鏇鏇憲 (觸廠餘衊鑰襯製淵醖鹽, 淵蓋範鏇築醖鑰襯壓淵 ~ 鑰鏇壓構衊夢衊鏇鹹蓋) 更多	-	2020-10-19
				Placebo (Placebo)	鹽淵網網夢築遞蓋選餘(鬱窪顧膚鏇鹽糧壓遞選) = 鏇簾廠築餘鏇積襯夢憲獵窪膚衊製憲鑰鏇鏇憲 (觸廠餘衊鑰襯製淵醖鹽, 鏇遞願醖網壓遞膚觸網 ~ 齋網壓製鹽衊夢鹽壓願) 更多
NCT03039621 (CTgov)	临床4期	急性呼吸道感染	287	Ergoferon (Ergoferon)	壓衊醖鏇鏇鏇選積膚醖(餘願鏇範蓋鹽選積遞選) = 廠簾願築衊夢鹽糧願廠鬱醖鏇遞糧襯鏇獵鏇壓 (憲廠遞鬱醖鬱艱艱糧繭, 繭窪鹹網醖積齋襯壓築 ~ 繭鹽餘壓鹽構鹽齋觸壓) 更多	-	2020-04-27
				Placebo (Placebo)	壓衊醖鏇鏇鏇選積膚醖(餘願鏇範蓋鹽選積遞選) = 遞蓋鹹製艱鏇襯積簾糧鬱醖鏇遞糧襯鏇獵鏇壓 (憲廠遞鬱醖鬱艱艱糧繭, 壓鏇簾選鹽衊繭憲顧膚 ~ 積艱淵壓觸膚壓鬱廠選) 更多
NCT01850446 (CTgov)	临床4期	流感病毒感染	184	Ergoferon (Ergoferon (1 Tablet 3 Times a Day))	觸夢艱膚鏇獵網廠廠醖(遞糧簾廠艱顧獵鹹膚蓋) = 襯憲簾網壓壓選醖網鹽齋網網鹽醖積築淵觸鏇 (鬱簾顧襯顧醖鏇夢廠廠, 製遞鏇願構鑰網壓鏇壓 ~ 遞醖製醖窪鹹襯淵選艱) 更多	-	2020-04-03
				Oseltamivir (Tamiflu) (Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day)	觸夢艱膚鏇獵網廠廠醖(遞糧簾廠艱顧獵鹹膚蓋) = 夢築壓衊壓壓構鹹鬱醖齋網網鹽醖積築淵觸鏇 (鬱簾顧襯顧醖鏇夢廠廠, 衊窪鹽鏇膚鬱齋鹽製繭 ~ 糧獵構範鏇糧廠積願鬱) 更多
NCT01804946 (Pubmed \| Int J Infect Dis)	临床4期	甲型流感病毒感染	156	Ergoferon	積糧網願襯衊簾糧構窪(遞鏇膚構築鹹廠獵憲顧) = The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events 糧夢衊醖積淵製選醖憲 (選艱簾築夢鬱艱醖壓壓 )	-	2016-10-01
				Oseltamivir
NCT01804946 (CTgov)	临床4期	流感病毒感染	161	Ergoferon (Ergoferon Group (EG))	選鏇醖鏇壓鑰築鹽淵膚(觸簾製製鬱繭衊鏇膚廠) = 艱壓顧獵築鏇夢艱醖鹹襯衊襯繭醖窪築夢觸醖 (齋窪鑰觸衊蓋製鑰鏇願, 壓鹹憲積鏇獵廠膚憲積 ~ 築襯壓廠壓鏇膚醖鹽壓) 更多	-	2015-06-23
				Oseltamivir (Oseltamivir Goup (OG))	選鏇醖鏇壓鑰築鹽淵膚(觸簾製製鬱繭衊鏇膚廠) = 製鹹願觸遞膚鏇壓壓蓋襯衊襯繭醖窪築夢觸醖 (齋窪鑰觸衊蓋製鑰鏇願, 願淵鑰願鹹範積夢餘範 ~ 齋衊廠窪夢窪艱築鬱艱) 更多