Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections

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: NCT03162458
Recruitment Status : Completed
First Posted : May 22, 2017
Results First Posted : August 3, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Brief Summary:

Purpose of the study:

  • To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.
  • To assess safety of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.

Condition or disease Intervention/treatment Phase
Acute Upper Respiratory Infections Drug: Anaferon for children (liquid dosage form) Drug: Placebo (liquid dosage form) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon for Children Liquid Dosage Form in the Treatment of Acute Upper Respiratory Infections
Actual Study Start Date : January 22, 2015
Actual Primary Completion Date : April 29, 2015
Actual Study Completion Date : April 29, 2015

Arm Intervention/treatment
Experimental: Anaferon for children Drug: Anaferon for children (liquid dosage form)
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.

Placebo Comparator: Placebo Drug: Placebo (liquid dosage form)
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.




Primary Outcome Measures :
  1. Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data) [ Time Frame: From the time of randomization until the time of recovery/improvement, assessed up to 14 days ]
    based on patient diary data

  2. Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient). [ Time Frame: On days 1-5 of observation ]

    The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.

    The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).

    The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).

    Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.



Secondary Outcome Measures :
  1. Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) [ Time Frame: On Days 2-5 of the treatment ]
    based on patient diary data

  2. Average Duration of Fever (i.e. Body Temperature >37.3°С) [ Time Frame: From the time of randomization until the time of normal body temperature, assessed up to 14 days ]
    based on patient diary data

  3. Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) [ Time Frame: On Days 2-5 of the treatment ]
    based on patient diary data

  4. Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation [ Time Frame: On Days 2-5 of observation ]
    based on patient diary data

  5. Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination [ Time Frame: On Days 1, 3, 6 of the treatment ]

    The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.

    The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).

    The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).

    Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.


  6. Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination) [ Time Frame: on Days 1, 3, 6 ]

    The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.

    The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).

    The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).

    Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.


  7. Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) [ Time Frame: on Days 1-5 of treatment ]
    based on patient diary data

  8. Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation [ 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:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of both sexes aged 1 month to 3 years.
  2. Diagnosis of acute upper respiratory infection based on a doctor's examination of the patient: body temperature at least 37.8°C when visiting a doctor + symptom scores ≥3 (presence of at least 1 general symptom and 1 nasal/ throat/chest symptom).
  3. The first 24 hours from the beginning of manifestations of acute upper respiratory infection.
  4. Acute respiratory viral infections season.
  5. The possibility to start treatment within 24 hours of the onset of acute upper respiratory infection symptoms.
  6. 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 or the presence of a disease requiring usage of antibacterial drugs starting from day 1 of the illness onset.
  2. Clinical symptoms of severe influenza/ARI (acute respiratory infection) requiring hospitalization.
  3. Suspected early manifestations of diseases that have symptoms similar to ARI symptoms (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathology).
  4. Documented (prior diagnosis) or suspected disease such as

    • primary or secondary immunodeficiency: а) lymphoid immunodeficiency (T-cell and/or B-cell immunity, immunodeficiencies with predominant antibody deficit, b) phagocyte deficits; c) complement factor deficit; d) combined immunodeficiency including AIDS secondary to HIV infection; toxic, autoimmune, infectious, or radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, autoimmune and allergic diseases;
    • cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, congenital malformations of the respiratory system, including malformations of upper respiratory tract, and other chronic lung disease;
    • malignant neoplasm.
  5. Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
  6. Medical history of polyvalent allergy.
  7. Allergy/ intolerance to any of the components of medications used in the treatment.
  8. Use of medications listed in 'Prohibited concomitant treatments/medications' within 2 weeks before study entry.
  9. Drug use or alcohol use (more than 2 alc. units daily) by the patient's parent(s)/adopter(s).
  10. Mental disorders of patient's parent(s)/adopter(s).
  11. Patients 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.
  12. Participation in other clinical studies in the course of 3 months (or 1-2 months for infants under two months of age) prior to the inclusion in the trial.
  13. Patient's parents/adopters are related to the clinical trial site's research staff 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.
  14. The patient's parent/adopter works for OOO "NPF "MATERIA MEDICA HOLDING" (i.e., the company's employee, part-time employee under contract or appointed official in charge of the trial, or their immediate family).

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): NCT03162458


Locations
Layout table for location information
Russian Federation
LLC Center for Vaccine Prevention "DIAVAKS"
Moscow, Russian Federation, 129515
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, Russian Federation, 614066
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Saint Petersburg, Russian Federation, 192212
St. Petersburg State Health Care Institution "Children's City Polyclinic No. 45 Nevsky District"
Saint Petersburg, Russian Federation, 193312
Alliance Biomedical-Russian Group LLC
Saint Petersburg, Russian Federation, 194356
St. Petersburg State Budgetary Healthcare Institution "Children's City Hospital No. 22"
Saint Petersburg, Russian Federation, 196650
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: NCT03162458    
Other Study ID Numbers: MMH-AD-006
First Posted: May 22, 2017    Key Record Dates
Results First Posted: August 3, 2018
Last Update Posted: November 28, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases