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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Upper Respiratory Infections

Intervention / Treatment
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* Drug: Anaferon for children (liquid dosage form)
* Drug: Placebo (liquid dosage form)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes aged 1 month to 3 years. 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). The first 24 hours from the beginning of manifestations of acute upper respiratory infection. Acute respiratory viral infections season. The possibility to start treatment within 24 hours of the onset of acute upper respiratory infection symptoms. 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: Suspected pneumonia or bacterial infection or the presence of a disease requiring usage of antibacterial drugs starting from day 1 of the illness onset. Clinical symptoms of severe influenza/ARI (acute respiratory infection) requiring hospitalization. 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). 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. 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. Use of medications listed in 'Prohibited concomitant treatments/medications' within 2 weeks before study entry. Drug use or alcohol use (more than 2 alc. units daily) by the patient's parent(s)/adopter(s). Mental disorders of patient's parent(s)/adopter(s). 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. 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. 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. 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).

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anaferon for children<br> | Drug: Anaferon for children (liquid dosage form)<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo (liquid dosage form)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data) | based on patient diary data | From the time of randomization until the time of recovery/improvement, assessed up to 14 days | 
| 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). | 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. | On days 1-5 of observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | based on patient diary data | On Days 2-5 of the treatment | 
| Average Duration of Fever (i.e. Body Temperature >37.3°С) | based on patient diary data | From the time of randomization until the time of normal body temperature, assessed up to 14 days | 
| Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | based on patient diary data | On Days 2-5 of the treatment | 
| Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | based on patient diary data | On Days 2-5 of observation | 
| Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination | 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. | On Days 1, 3, 6 of the treatment | 
| 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) | 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. | on Days 1, 3, 6 | 
| Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | based on patient diary data | on Days 1-5 of treatment | 
| Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation |  | From the time of randomization up to 14 days |