Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03039621
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Brief Summary:
The purpose of this study is to obtain additional data on efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections in children aged from 6 months to 6 years.

Condition or disease Intervention/treatment Phase
Acute Respiratory Viral Infections Drug: Ergoferon Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 7, 2016
Actual Primary Completion Date : January 9, 2019
Actual Study Completion Date : January 9, 2019

Arm Intervention/treatment
Experimental: Ergoferon
1 tablet 3 times a day
Drug: Ergoferon
Placebo Comparator: Placebo
1 tablet 3 times a day
Drug: Placebo



Primary Outcome Measures :
  1. Time to the alleviation of all symptoms of the acute respiratory viral infection based on patient diary data [ Time Frame: From the time of randomization until the time of alleviation of all symptoms, assessed up to 10 days ]

Secondary Outcome Measures :
  1. Time to a normal body temperature [ Time Frame: From the time of randomization until the time of normal body temperature, assessed up to 10 days ]
  2. Time to the alleviation of general/non-specific symptoms [ Time Frame: From the time of randomization until the time of absence of general/non-specific symptoms, assessed up to 10 days ]
  3. Time to the alleviation of nasal/throat/chest symptoms [ Time Frame: From the time of randomization until the time of absence of nasal/throat/chest symptoms, assessed up to 10 days ]
  4. Total severity scores of disease based on patient diary data [ Time Frame: Study entry, Days 2-6 ]
    based on patient diary data

  5. Severity of acute respiratory viral infection based on patient diary data [ Time Frame: Study entry, Days 1-6 ]
    area under the curve for the total severity scores

  6. Percentage of patients with recovery based on patient diary data [ Time Frame: Study entry, Days 1-6 ]
  7. Number of antipyretic use (for prescribed indications) based on patient diary data [ Time Frame: Study entry, Days 1-6 ]
  8. Percentage of patients with complications of acute respiratory viral infection, including those requiring antibiotic administration or hospitalization) [ Time Frame: From the time of randomization up to 14 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes aged from 6 months to 6 years old .
  2. Diagnosis of acute respiratory viral infection based on physician examination: oral temperature of at least 38.0°C at examination + total symptom severity score ≥5.
  3. The first 24 hours from the beginning of manifestations of acute respiratory viral infection .
  4. Patients presenting during a seasonal morbidity raise of acute respiratory viral infection.
  5. Availability of a patient information sheet (Informed Consent form) signed by the patient's parents/adopters to confirm the child's participation in the clinical trial signed by one parent/adopter of patient.

Exclusion Criteria:

  1. Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media, urinary tract infection, etc.) requiring antibacterial therapy starting from Day 1 of the illness onset.
  2. Suspected initial manifestations of diseases that have symptoms similar to ARVI (other infectious diseases, influenza-like syndrome at the onset of Autoimmune Disorders of Connective Tissue, oncohematology and other pathology).
  3. Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.
  4. Medical history or prior diagnosis of primary and secondary immunodeficient disease; oncology disease.
  5. Exacerbation or decompensation of a chronic disease (diabetes mellitus, infantile cerebral palsy, mucoviscidosis/cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, сongenital malformations of the respiratory system and ETN, etc.) that would affect the patient's ability to participate in the clinical trial.
  6. Malabsorption syndrome, including congenital or acquired lactose intolerance/lactase deficiency or any other disaccharidase deficiency and galactosemia.
  7. Allergy/ intolerance to any of the components of medications used in the treatment.
  8. Course intake of medicines listed in the section "Prohibited concomitant treatment" for 2 weeks prior to the enrollment in the trial.
  9. Subjects whose parents/adopters, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
  10. Participation in other clinical trials within 3 months prior to the enrollment in this study.
  11. Patient's parents/adopters are related to the research staff of the clinical investigative site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
  12. The patient's parent/adopter works for OOO "NPF "MATERIA MEDICA HOLDING" (i.e., is the company's employee, temporary contract worker or appointed official responsible for carrying out the research) or the immediate relative.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039621


Locations
Layout table for location information
Kazakhstan
Kazakh Medical Continuing Education University
Almaty, Kazakhstan, 050057
Astana Medical University
Astana, Kazakhstan, 010000
Karaganda State Medical University
Karaganda, Kazakhstan, 100000
Russian Federation
Municipal autonomous institution "Children's City Clinical Hospital №11"
Ekaterinburg, Russian Federation, 620028
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', Russian Federation, 420012
Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation
Moscow, Russian Federation, 117997
Limited Liability Company "Diagnostics and Vaccines"
Moscow, Russian Federation, 129515
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Moscow, Russian Federation, 192071
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm', Russian Federation, 614066
State Budgetary Institution of Healthcare of the Samara Region "Samara City Children's Clinical Hospital named after N.N. Willow New
Samara, Russian Federation, 443079
Volgograd State Medical University
Volgograd, Russian Federation, 400131
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation
Yaroslavl', Russian Federation, 150000
Sponsors and Collaborators
Materia Medica Holding

Layout table for additonal information
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT03039621     History of Changes
Other Study ID Numbers: MMH-ER-009
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Virus Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs