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Purpose of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaferon for children | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anaferon for children (liquid dosage form) | Drug | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
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
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLC Center for Vaccine Prevention "DIAVAKS" | Moscow | 129515 | Russia | |||
| Municipal Health Care Institution "City Child Health Clinical Polyclinic №5" |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anaferon for Children | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo (liquid dosage form) | Drug | 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. |
|
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 |
| Perm |
| 614066 |
| Russia |
| St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44" | Saint Petersburg | 192212 | Russia |
| St. Petersburg State Health Care Institution "Children's City Polyclinic No. 45 Nevsky District" | Saint Petersburg | 193312 | Russia |
| Alliance Biomedical-Russian Group LLC | Saint Petersburg | 194356 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "Children's City Hospital No. 22" | Saint Petersburg | 196650 | Russia |
| Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation | Yaroslavl | 150000 | Russia |
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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anaferon for Children | 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. |
| BG001 | Placebo | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intention to treat set | Posted | Mean | Standard Deviation | hours | From the time of randomization until the time of recovery/improvement, assessed up to 14 days |
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| Primary | 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. | Intention to treat set | Posted | Mean | Standard Deviation | AUC score*day | On days 1-5 of observation |
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| Secondary | Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | based on patient diary data | Intention to treat set | Posted | Number | percentage of participants | On Days 2-5 of the treatment |
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| Secondary | Average Duration of Fever (i.e. Body Temperature >37.3°С) | based on patient diary data | Intention to treat set | Posted | Mean | Standard Deviation | hours | From the time of randomization until the time of normal body temperature, assessed up to 14 days |
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| Secondary | Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data) | based on patient diary data | Intention to treat set | Posted | Mean | Standard Deviation | °C | On Days 2-5 of the treatment |
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| Secondary | Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation | based on patient diary data | Intention to treat set | Posted | Number | percentage of participants | On Days 2-5 of observation |
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| Secondary | 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. | Intention to treat set | Posted | Mean | Standard Deviation | Score | On Days 1, 3, 6 of the treatment |
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| Secondary | 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. | Intention to treat set | Posted | Mean | Standard Deviation | AUC score*day | on Days 1, 3, 6 |
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| Secondary | Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data) | based on patient diary data | Intention to treat set | Posted | Mean | Standard Deviation | Number of intakes | on Days 1-5 of treatment |
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| Secondary | Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation | Intention to treat | Posted | Number | percentage of participants | From the time of randomization up to 14 days |
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Adverse/Serious adverse events were registered from Day 1 to Day 14
Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=142, Safety Population)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anaferon for Children | 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. | 0 | 71 | 7 | 71 | ||
| EG001 | Placebo | 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. | 0 | 71 | 4 | 71 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperactivity | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Herpes Labialis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Administration related reaction | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
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| Eustachitis | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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| Rhinitis purulent | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Daytime sleepiness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Purulent conjunctivitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Right otitis media (acute, non-suppurative) | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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| Bilateral otitis media | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Putilovskiy, MD, PhD, Head of department of clinical trials | Materia Medica Holding | +74952761571 | 302 | PutilovskiyMA@materiamedica.ru |
| ID | Term |
|---|---|
| C547732 | anaferon |
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