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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.

Start Date07 Oct 2016

Sponsor / Collaborator

OOO NPF Materia Medica Holding

NCT04413929 / CompletedNot Applicable

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.

Start Date01 Oct 2016

Sponsor / Collaborator

OOO NPF Materia Medica Holding

100 Clinical Results associated with Ergoferon(Materia Medica Holding Research And Production Company)

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100 Translational Medicine associated with Ergoferon(Materia Medica Holding Research And Production Company)

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100 Patents (Medical) associated with Ergoferon(Materia Medica Holding Research And Production Company)

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15

Literatures (Medical) associated with Ergoferon(Materia Medica Holding Research And Production Company)

01 Sep 2023·Bulletin of Experimental Biology and Medicine

Analysis of General Toxicity of Ergoferon

Article

Author: 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.

15 Nov 2021·Canadian Respiratory JournalQ4 · MEDICINE

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

Q4 · MEDICINE

ArticleOA

Author: 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.

01 Dec 2019·International Journal of Infectious Diseases

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

Letter

Author: Putilovskiy, Mikhail ; Andrianova, Elena

100 Deals associated with Ergoferon(Materia Medica Holding Research And Production Company)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	S01AD D06BB	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	RU	Materia Medica Holding Research And Production Company	-
Respiratory Tract Infections	RU	Materia Medica Holding Research And Production Company	-
Virus Diseases	RU	Materia Medica Holding Research And Production Company	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute upper respiratory tract inflammation	Preclinical	-	OOO NPF Materia Medica Holding	01 Dec 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01850446 (CTgov)	Phase 4	Influenza, Human	184	Ergoferon (Ergoferon (1 Tablet 3 Times a Day))	rmcbhlheld(rohgyfnqkz): Z-value = 8.56; Z-value = 7.31 View more	-	03 Apr 2020
				Oseltamivir (Tamiflu) (Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day)
NCT03039699 (CTgov)	Phase 4	Intestinal infections	259	Ergoferon (Ergoferon)	gcnsgrfnbc(ltldlemnvt) = jxshnhkbyr tllpjyitab (esoamrmrxl, nxrzxsvsnt - vhidnrncnu) View more	-	19 Oct 2020
				Placebo (Placebo)	gcnsgrfnbc(ltldlemnvt) = xumgkhxxlg tllpjyitab (esoamrmrxl, txbdskddui - enrytfrdxf) View more
NCT01765920 (CTgov)	Phase 3	Acute upper respiratory tract inflammation	342	Ergoferon (Ergoferon (5 ml 3 Times a Day))	vaugxhtpos(cdszdhpxel) = jyrfyajjky fkvvvxufth (icfypqegie, qbobdbjspz - whlddbxekk) View more	-	11 Dec 2020
				Placebo (Placebo (5 ml 3 Times a Day))	vaugxhtpos(cdszdhpxel) = oqnxgyxzbt fkvvvxufth (icfypqegie, btvwwwpwdm - cdpikgqoyj) View more
NCT01843842 (CTgov)	Phase 3	Acute upper respiratory tract inflammation	306	Ergoferon (Ergoferon in Liquid Dosage Form)	- View more	-	03 Aug 2018
				Placebo (Placebo)
NCT01804946 (CTgov)	Phase 4	Influenza, Human	161	Ergoferon (Ergoferon Group (EG))	kcxzkpefga(arbhmpzmqe): Risk Difference (RD) = 0 (95% CI)	-	23 Jun 2015
				Oseltamivir (Oseltamivir Goup (OG))
NCT01804946 (Pubmed \| Int J Infect Dis)	Phase 4	Influenza A virus infection	156	Ergoferon	(jjasmzyyae) = The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events mwikfpiocp (duhztetuzg )	-	01 Oct 2016
				Oseltamivir
NCT03039621 (CTgov)	Phase 4	Acute respiratory infections	287	Ergoferon (Ergoferon)	wlrlzbzobd(zqtetutdrg) = wryioncttt meqbbdkqae (uuxfysxfyy, bcwmojyegu - pqyhnoaosy) View more	-	27 Apr 2020
				Placebo (Placebo)	wlrlzbzobd(zqtetutdrg) = xzrsrtexqo meqbbdkqae (uuxfysxfyy, zcohjnnmbf - sdqaehtasp) View more