Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children

NCT03039621 | Completed Phase 4 Results

• 1 other identifier: MMH-ER-009
• Study Type: interventional
• Target: 287
• Locations: 2 countries
• Sites: 13

Brief Summary

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.

Conditions

Acute Respiratory Viral Infections

Outcome Measures

Primary Outcomes (1)

• Time to Alleviation of All ARVI Symptoms.

  Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.

  14 days of observation.

Secondary Outcomes (8)

• Time to Normalization of Body Temperature.

  14 days of observation.

• Time to Alleviation of Flu-like Nonspecific Symptoms.

  14 days of observation.

• Time to Alleviation of Respiratory Symptoms.

  14 days of observation.

• Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.

  On days 2-6 of the observation period.

• ARVI Severity.

  On days 2-6 of the observation period.

Study Arms (2)

Ergoferon

EXPERIMENTAL

Tablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours. The drug is administered outside a meal (in the interval between meals or 15 minutes before meal or fluid intake). Keep the tablet in the mouth, without swallowing, until completely dissolved. For young children (aged 6 months to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature. The therapy lasts for 5 days.

Drug: Ergoferon

Placebo

PLACEBO COMPARATOR

Placebo using Ergoferon scheme.

Drug: Placebo

Interventions

Ergoferon DRUG

For oral use.

Ergoferon

Placebo DRUG

For oral use.

Placebo

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients of both genders aged from 6 months to 6 years old.
• ARVI based on medical examination: oral temperature of at least 38.0°C at examination + total symptom severity ≥5.
• The first 24 hours after ARVI onset.
• Seasonal raise in ARVI incidence.
• Availability of signed information sheet for parents/adopters(Informed Consent Form) for participation in the clinical trial.

You may not qualify if:

• Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media, urinary tract infection, etc.) requiring a prescription of antibacterial product from the first day of the disease.
• Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).
• Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.
• Medical history of primary and secondary immunodeficiency; oncologic conditions.
• Aggravation or decompensation of chronic disease (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ETN organs/ear, throat, mouth, tongue, larynx, trachea, neck and salivary and thyroid glands, etc.) which affect the patient's ability to participate in the clinical study.
• Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
• Allergy/hypersensitivity to any components of the drug product used in the therapy.
• Patients whose parents/adoptive parents will not fulfil the requirements during the study or follow the order of administration of the studied drug products from the investigator's point of view.
• Participation in other clinical trials within 3 months prior to the enrollment in this study.
• The patient's parent/adoptive parent is a study specialist at the centre and is directly involved in the study or is an immediate family member of the investigator. Spouses parents, children or siblings, regardless of whether they are siblings or adopted are considered immediate family members.
• The patient's parent/adoptive parent works at OOO "NPF "MATERIA MEDICA HOLDING", i.e. they are employees of the Company, temporary employees on a contract basis or appointed official responsible for conduction of the study or their immediate family members.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (13)

Kazakh Medical Continuing Education University

Almaty, 050057, Kazakhstan

Location

Astana Medical University

Astana, 010000, Kazakhstan

Location

Karaganda State Medical University

Karaganda, 100000, Kazakhstan

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation

Kazan', 420012, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation

Moscow, 117997, Russia

Location

Limited Liability Company "Diagnostics and Vaccines"

Moscow, 129515, Russia

Location

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"

Moscow, 192071, Russia

Location

Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"

Perm, 614066, Russia

Location

State Budgetary Institution of Healthcare of the Samara Region "Samara City Children's Clinical Hospital named after N.N. Willow New

Samara, 443079, Russia

Location

Volgograd State Medical University

Volgograd, 400131, Russia

Location

Yaroslavl State Medical University/Children's Clinic # 5

Yaroslavl, 150000, Russia

Location

Yaroslavl State Medical University/Clinical Hospital # 8

Yaroslavl, 150000, Russia

Location

Municipal autonomous institution "Children's City Clinical Hospital №11"

Yekaterinburg, 620028, Russia

Location

MeSH Terms

Interventions

ergoferon

Results Point of Contact

• Title: Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: February 1, 2017
• Study Start: October 7, 2016
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: August 27, 2021
• Results First Posted: April 27, 2020

Record last verified: 2019-05

Locations

KA (3); RU (10)