Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children

NCT02072174 | Completed Phase 4 Results

• 1 other identifier: MMH-AD-004
• Study Type: interventional
• Target: 569
• Locations: 3 countries
• Sites: 27

Brief Summary

The purpose of this study is: • To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment of influenza and acute respiratory viral infections in children

Conditions

Influenza and Acute Respiratory Viral Infections

Outcome Measures

Primary Outcomes (1)

• Average Illness Duration

  Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below. Based on patient diary data.

  From the time of randomization until the time of recovery/improvement (days 1-14)

Secondary Outcomes (8)

• Percentage of Patients With Recovery/Improvement in Health

  on days 2, 3, 4 and 5 of the treatment

• Changes in Body Temperature

  baseline and days 2, 3, 4 and 5 of observation treatment

• Percentage of Patients With Normal Body Temperature (≤37.0ºС)

  on days 2, 3, 4 and 5 of observation treatment

• Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.

  on days 2-6 of observation treatment

• Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment

  on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)

Study Arms (2)

Anaferon for Children

EXPERIMENTAL

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. From day 2 through 5, one tablet is administered three times daily.

Drug: Anaferon for Children

Placebo

PLACEBO COMPARATOR

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. From day 2 through 5, one tablet is administered three times daily.

Drug: Anaferon for Children

Interventions

Anaferon for Children DRUG

Anaferon for children: For oral use.

Also known as: Anaferon for Children in tablets

Anaferon for Children; Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients of both sexes aged 3-12 years inclusively.
• Diagnosis of influenza/ARVI according to physician's examination: body temperature ≥ 38.0°C at the time of examination + symptom score ≥ 4 (at least 1 systemic symptom ≥2 and 1 nasal/throat/chest symptom ≥2 or several symptoms ≥ 1 score).
• The first 24 hours from the beginning of manifestations of influenza/ARVI.
• The possibility to start therapy within 24 hours from the first symptoms of ARVI.
• Availability of a patient information sheet (Informed Consent form) for parents/adoptive parents for participation in the study signed by one of the parents/adoptive parents.

You may not qualify if:

• Suspected pneumonia, bacterial infection or severe disease requiring antibacterial products (including sulfanilamides) starting from the first day of the disease.
• Clinical symptoms of severe influenza/ARVI requiring hospitalization.
• Suspected initial manifestations of the diseases having the symptoms similar to the ones of influenza/ARVI (other infectious diseases, influenza-like syndrome at debut of systemic connective tissue diseases, oncohematological and other diseases).
• Medical history of primary and secondary immunodeficiencies: а) lymphoid system immunodeficiencies (Т-cell and/or B-cell, immunodeficiencies with predominant antibody deficiency); b) phagocytic deficiencies; c) complement factor deficiency; d) combined immunodeficiencies including AIDS secondary to HIV-infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; systemic lymphocytopenic syndrome; polyclonal lymphocytic activation syndrome; postsplenectomic syndrome; congenital asplenia; immune complex pathological syndrome associated with infectious, autoimmune and allergic diseases.
• Medical history of sarcoidosis.
• Oncology.
• Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
• Medical history of polyvalent allergy.
• Allergy/intolerance to any of the components of medications used in the treatment.
• Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
• Drug addiction, alcohol consumption at more than 2 alcohol units per day by the subject's parents/adoptive parents.
• Mental diseases of the subject, parents/adoptive parents.
• Subjects whose parents/adoptive parents, according to the investigator's point of view, will not follow the observation requirements during the study or study product dosing regimen.
• Parent/adoptive parent of the subject is related to the investigator team of medical facility directly involved in the study or is a close relative of the investigator. Close relatives include spouse, parents, children or brothers (sisters) regardless of whether they are biological or adoptive ones.
• Parent/adoptive parent of the subject is working in OOO "NPF "Materia Medica Holding", i.e. is the company official, temporary contract worker or an appointed official responsible for the study or their close relatives.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (27)

City Child Health Clinical Polyclinic №13

Minsk, 220024, Belarus

Location

Municipal Health Care Institution "City Child Health Clinical Polyclinic №10"

Minsk, 220118, Belarus

Location

City Child Health Clinical Polyclinic №17

Minsk, 220131, Belarus

Location

Clinic of State Budgetary Institution "Research Institute of nutrition" of the Russian Academy of Medical Sciences

Moscow, 109240, Russia

Location

Russian National Research Medical University named after N.I. Pirogov

Moscow, 117997, Russia

Location

Russian National Research Medical University

Moscow, 117997, Russia

Location

Russian National Research Pirogov Medical University

Moscow, 117997, Russia

Location

State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"

Moscow, 119991, Russia

Location

State Budgetary Institution of Health, "Children's City Hospital № 9 named after G.N. Speranskii"

Moscow, 123317, Russia

Location

State Budgetary Educational Institution of Additional Professional Education "Russian Russian Medical Academy of Postgraduate Education" of Ministry of Health of Russian Federation

Moscow, 123995, Russia

Location

State Budgetary Educational Institution of Higher Professional Education " Nizhny Novgorod State Medical Academy" of Ministry of Health of Russian Federation

Nizhny Novgorod, 603005, Russia

Location

State Budgetary Educational Institution of Higher Professional Education ''Novosibirsk State Medical University'' of Ministry of Health of Russian Federation

Novosibirsk, 630091, Russia

Location

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

Perm, 614066, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "Rostov State Medical University"

Rostov-on-Don, 344022, Russia

Location

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

Saint Petersburg, 192212, Russia

Location

St. Petersburg State health institution " City Child Health Polyclinic № 45"

Saint Petersburg, 193312, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation

Saint Petersburg, 194100, Russia

Location

Limited Liability Company "Alliance Biomedical-Russian group"

Saint Petersburg, 194356, Russia

Location

Co.Ltd "Clinic Allergomed"

Saint Petersburg, 196084, Russia

Location

State Health Care Institution "Child Health City Hospital №22"

Saint Petersburg, 196650, Russia

Location

Bashkir State Medical University of Ministry of Health of Russian Federation

Ufa, 450000, Russia

Location

State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health of Russian Federation

Yaroslavl, 150000, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy"

Yaroslavl, 150000, Russia

Location

State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy

Yaroslavl, 150000, Russia

Location

Yaroslavl State Medical Academy

Yaroslavl, 150000, Russia

Location

Vinnytsya M.I. Pyrogov National Medical University

Vinnytsia, 21018, Ukraine

Location

Public institution "Zaporizhzhya city multidisciplinary children's hospital №5"

Zaporozh’ye, 69076, Ukraine

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

anaferon; Tablets

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

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

PutilovskiyMA@materiamedica.ru

+74952761571

Study Officials

• Elena Andrianova, Professor

  Materia Medica Holding

  STUDY DIRECTOR

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: February 14, 2014
• First Posted: February 26, 2014
• Study Start: October 8, 2014
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: July 12, 2019
• Results First Posted: July 12, 2019

Record last verified: 2019-07

Locations

BE (3); RU (22); UA (2)