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

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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

Tracking Information
First Submitted Date  ICMJE December 28, 2016
First Posted Date  ICMJE February 1, 2017
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE October 7, 2016
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03039621 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • 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 ]
  • 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 ]
  • 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 ]
  • Total severity scores of disease based on patient diary data [ Time Frame: Study entry, Days 2-6 ]
    based on patient diary data
  • 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
  • Percentage of patients with recovery based on patient diary data [ Time Frame: Study entry, Days 1-6 ]
  • Number of antipyretic use (for prescribed indications) based on patient diary data [ Time Frame: Study entry, Days 1-6 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Respiratory Viral Infections
Intervention  ICMJE
  • Drug: Ergoferon
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ergoferon
    1 tablet 3 times a day
    Intervention: Drug: Ergoferon
  • Placebo Comparator: Placebo
    1 tablet 3 times a day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
287
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
288
Actual Study Completion Date  ICMJE January 9, 2019
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03039621
Other Study ID Numbers  ICMJE MMH-ER-009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Materia Medica Holding
Study Sponsor  ICMJE Materia Medica Holding
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Materia Medica Holding
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP