Acute Upper Respiratory Tract Infections
Conditions
Brief summary
The purpose of this study is: * to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children; * to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.
Detailed description
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).
Interventions
DRUGErgoferon
Safety and Efficiency of liquid dosage form
DRUGPlacebo
Safety and Efficiency of liquid dosage form
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Patients of both sexes aged over 3 years and under 18 years. 2. Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity. 3. The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection. 4. Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial. 5. Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.
Exclusion criteria
1. Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides). 2. Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology). 3. Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases. 4. Medical history of sarcoidosis. 5. Oncological diseases. 6. Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial. 7. Medical history of polyvalent allergy. 8. Allergy/ intolerance to any of the components of medications used in the treatment. 9. Impaired glucose tolerance, diabetes mellitus. 10. Hereditary fructose intolerance (as the study drug contains maltitol). 11. Intake of medicines listed in the section Prohibited concomitant treatment for 1 month prior to the inclusion in the trial. 12. Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study. 13. Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters. 14. Mental disorders of patient or of patient's parents/adopters. 15. Patient's parents/ adopters, who from 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. 16. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial. 17. Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted. 18. 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 the carrying out the research) or the immediate relative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) | On day 2, 3 and 4 of observation | Based on the data mentioned in a patient's diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Normal Body Temperature (≤37.0ºС) | On day 2, 3, 4, 5 of observation | Axillary temperature (morning and evening) decline to or below 37.0 ºС |
| Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | on Days 2, 3, 4, 5 of Observation | The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5. |
| Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | baseline and days 2, 3, 4 and 5 of observation | Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI 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. |
| Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | baseline and days 2, 3, 4 and 5 of observation | — |
| Number of Intakes of Antipyretics if Indicated | On day 1, 2, 3, 4 and 5 of the treatment | Based on data mentioned in a patient's diary |
| Percentage of Patients With Exacerbation of the Disease Course | On days 1-6 of observation | The development of disease complications requiring antibiotics administration or hospitalization |
| Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | On days 1-6 of observation | The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ergoferon in Liquid Dosage Form 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day | 154 |
| Placebo 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day | 152 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Do not meet inclusion criteria | 1 | 1 |
Baseline characteristics
| Characteristic | Ergoferon in Liquid Dosage Form | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 9.8 years STANDARD_DEVIATION 4.1 | 10.2 years STANDARD_DEVIATION 4.2 | 10.0 years STANDARD_DEVIATION 4.1 |
| Region of Enrollment Russia | 154 Participants | 152 Participants | 306 Participants |
| Sex: Female, Male Female | 67 Participants | 80 Participants | 147 Participants |
| Sex: Female, Male Male | 87 Participants | 72 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 154 | 2 / 152 |
| serious Total, serious adverse events | 0 / 154 | 0 / 152 |
Outcome results
Primary
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Based on the data mentioned in a patient's diary
Time frame: On day 2, 3 and 4 of observation
Population: Per Protocol set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) | Day 2 | 9 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) | Day 3 | 21 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) | Day 4 | 44 percentage of participants |
| Placebo | Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) | Day 2 | 1 percentage of participants |
| Placebo | Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) | Day 3 | 11 percentage of participants |
| Placebo | Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data) | Day 4 | 33 percentage of participants |
p-value: 0.016Global Test Statistic
Secondary
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI 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.
Time frame: baseline and days 2, 3, 4 and 5 of observation
Population: Per Protocol set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon in Liquid Dosage Form | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | Fever | 26.7 hours | Standard Deviation 22.9 |
| Ergoferon in Liquid Dosage Form | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | Nasal/ throat/ chest symptoms | 84.0 hours | Standard Deviation 33.2 |
| Ergoferon in Liquid Dosage Form | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | Non-specific symptoms | 55.2 hours | Standard Deviation 31 |
| Ergoferon in Liquid Dosage Form | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | All symptoms | 86.0 hours | Standard Deviation 30.8 |
| Placebo | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | Non-specific symptoms | 60.8 hours | Standard Deviation 30.5 |
| Placebo | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | Fever | 31.6 hours | Standard Deviation 23.9 |
| Placebo | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | All symptoms | 91.1 hours | Standard Deviation 27.9 |
| Placebo | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | Nasal/ throat/ chest symptoms | 88.9 hours | Standard Deviation 29.9 |
Comparison: Duration of fever based on Patient Diary Datap-value: 0.1158Kruskal-Wallis
Comparison: Duration of non-specific symptoms based on Patient Diary Datap-value: 0.5755Kruskal-Wallis
Comparison: Duration of nasal/ throat/ chest symptoms based on Patient Diary Datap-value: 0.4331Kruskal-Wallis
Comparison: Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Datap-value: 0.356Kruskal-Wallis
Secondary
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Time frame: baseline and days 2, 3, 4 and 5 of observation
Population: Per Protocol set. The morning temperature in 13 patients (7 in the Ergoferon group and 6 in the placebo group) was excluded from the analysis due to mistakes in diaries.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon in Liquid Dosage Form | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 2, Morning | -0.96 °C | Standard Deviation 0.55 |
| Ergoferon in Liquid Dosage Form | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 3, Morning | -1.49 °C | Standard Deviation 0.47 |
| Ergoferon in Liquid Dosage Form | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 4, Morning | -1.77 °C | Standard Deviation 0.41 |
| Ergoferon in Liquid Dosage Form | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 5, Morning | -1.90 °C | Standard Deviation 0.37 |
| Placebo | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 5, Morning | -1.86 °C | Standard Deviation 0.38 |
| Placebo | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 2, Morning | -0.79 °C | Standard Deviation 0.53 |
| Placebo | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 4, Morning | -1.69 °C | Standard Deviation 0.44 |
| Placebo | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | Day 3, Morning | -1.30 °C | Standard Deviation 0.5 |
p-value: <0.0001Mixed Models Analysis
Secondary
Number of Intakes of Antipyretics if Indicated
Based on data mentioned in a patient's diary
Time frame: On day 1, 2, 3, 4 and 5 of the treatment
Population: Per Protocol set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon in Liquid Dosage Form | Number of Intakes of Antipyretics if Indicated | Day 2 | 0.20 Number of intakes | Standard Deviation 0.57 |
| Ergoferon in Liquid Dosage Form | Number of Intakes of Antipyretics if Indicated | Day 4 | 0.03 Number of intakes | Standard Deviation 0.26 |
| Ergoferon in Liquid Dosage Form | Number of Intakes of Antipyretics if Indicated | Day 3 | 0.08 Number of intakes | Standard Deviation 0.36 |
| Ergoferon in Liquid Dosage Form | Number of Intakes of Antipyretics if Indicated | Day 5 | 0.01 Number of intakes | Standard Deviation 0.17 |
| Ergoferon in Liquid Dosage Form | Number of Intakes of Antipyretics if Indicated | Day 1 | 0.84 Number of intakes | Standard Deviation 0.86 |
| Placebo | Number of Intakes of Antipyretics if Indicated | Day 5 | 0.00 Number of intakes | Standard Deviation 0 |
| Placebo | Number of Intakes of Antipyretics if Indicated | Day 1 | 0.85 Number of intakes | Standard Deviation 0.78 |
| Placebo | Number of Intakes of Antipyretics if Indicated | Day 2 | 0.30 Number of intakes | Standard Deviation 0.71 |
| Placebo | Number of Intakes of Antipyretics if Indicated | Day 3 | 0.09 Number of intakes | Standard Deviation 0.4 |
| Placebo | Number of Intakes of Antipyretics if Indicated | Day 4 | 0.03 Number of intakes | Standard Deviation 0.25 |
p-value: 0.4ANCOVA
Secondary
Percentage of Patients With Exacerbation of the Disease Course
The development of disease complications requiring antibiotics administration or hospitalization
Time frame: On days 1-6 of observation
Population: Per Protocol set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Exacerbation of the Disease Course | 0 percentage of participants |
| Placebo | Percentage of Patients With Exacerbation of the Disease Course | 0 percentage of participants |
Secondary
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Axillary temperature (morning and evening) decline to or below 37.0 ºС
Time frame: On day 2, 3, 4, 5 of observation
Population: Per Protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 2, Morning | 21 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 2, Evening | 29 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 3, Morning | 68 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 3, Evening | 59 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 4, Morning | 89 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 4, Evening | 81 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 5, Morning | 98 percentage of participants |
| Ergoferon in Liquid Dosage Form | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 5, Evening | 94 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 5, Evening | 95 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 2, Morning | 16 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 4, Morning | 86 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 2, Evening | 22 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 5, Morning | 97 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 3, Morning | 53 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 4, Evening | 78 percentage of participants |
| Placebo | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Day 3, Evening | 51 percentage of participants |
p-value: >0.05Fisher Exact
Secondary
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5.
Time frame: on Days 2, 3, 4, 5 of Observation
Population: Per Protocol set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 3, doctor's examination) | 3.6 Score | Standard Deviation 2.2 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 2, patient diary data) | 3.3 Score | Standard Deviation 3 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 3, patient diary data) | 5.6 Score | Standard Deviation 4.2 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 3, doctor's examination) | 1.7 Score | Standard Deviation 1.8 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 4, patient diary data) | 0.1 Score | Standard Deviation 0.3 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 2, patient diary data) | 4.4 Score | Standard Deviation 2.8 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 4, patient diary data) | 0.6 Score | Standard Deviation 1.1 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 3, doctor's examination) | 5.5 Score | Standard Deviation 3.7 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 4, patient diary data) | 2.3 Score | Standard Deviation 2 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 2, patient diary data) | 9.4 Score | Standard Deviation 6.1 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 4, patient diary data) | 3.1 Score | Standard Deviation 2.9 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 3, doctor's examination) | 0.3 Score | Standard Deviation 0.5 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 5, patient diary data) | 0.0 Score | Standard Deviation 0.2 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 3, patient diary data) | 0.3 Score | Standard Deviation 0.5 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 5, patient diary data) | 0.2 Score | Standard Deviation 0.8 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 2, patient diary data) | 0.8 Score | Standard Deviation 0.7 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 5, patient diary data) | 1.3 Score | Standard Deviation 1.5 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 3, patient diary data) | 1.7 Score | Standard Deviation 1.9 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 5, patient diary data) | 1.6 Score | Standard Deviation 2 |
| Ergoferon in Liquid Dosage Form | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 3, patient diary data) | 3.3 Score | Standard Deviation 2.2 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 5, patient diary data) | 1.6 Score | Standard Deviation 1.7 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 3, doctor's examination) | 0.4 Score | Standard Deviation 0.6 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 3, doctor's examination) | 1.9 Score | Standard Deviation 1.8 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 3, doctor's examination) | 3.7 Score | Standard Deviation 2.1 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 3, doctor's examination) | 6.0 Score | Standard Deviation 3.6 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 2, patient diary data) | 1.0 Score | Standard Deviation 0.8 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 2, patient diary data) | 4.1 Score | Standard Deviation 3.1 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 2, patient diary data) | 5.0 Score | Standard Deviation 2.8 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 2, patient diary data) | 11.1 Score | Standard Deviation 6.3 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 3, patient diary data) | 0.5 Score | Standard Deviation 0.6 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 3, patient diary data) | 1.9 Score | Standard Deviation 1.8 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 3, patient diary data) | 3.6 Score | Standard Deviation 2.1 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 3, patient diary data) | 6.4 Score | Standard Deviation 4.1 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 4, patient diary data) | 0.1 Score | Standard Deviation 0.4 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 4, patient diary data) | 0.8 Score | Standard Deviation 1.2 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 4, patient diary data) | 2.3 Score | Standard Deviation 1.4 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | All symptoms (Day 4, patient diary data) | 3.3 Score | Standard Deviation 2.5 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Fever (Day 5, patient diary data) | 0.0 Score | Standard Deviation 0.2 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Non-specific (Day 5, patient diary data) | 0.2 Score | Standard Deviation 0.6 |
| Placebo | Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data) | Nasal/Throat/Chest (Day 5, patient diary data) | 1.3 Score | Standard Deviation 1.2 |
Comparison: Fever (Day 3, doctor's examination)p-value: 0.0283Kruskal-Wallis
Comparison: Non-specific (Day 3, doctor's examination)p-value: 0.3264Kruskal-Wallis
Comparison: Nasal/Throat/Chest (Day 3, doctor's examination)p-value: 0.706Kruskal-Wallis
Comparison: All symptoms (Day 3, doctor's examination)p-value: 0.25Kruskal-Wallis
Comparison: Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)p-value: 0.244ANCOVA
Secondary
Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Time frame: On days 1-6 of observation
Population: Per Protocol set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Fever (Days 1-5, patient diary data) | 2.1 AUC score*day | Standard Deviation 1.6 |
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Non-specific (Days 1, 3, 6 doctor's examination) | 4.9 AUC score*day | Standard Deviation 3 |
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Non-specific (Days 1-5, patient diary data) | 8.7 AUC score*day | Standard Deviation 6.7 |
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Fever (Days 1, 3, 6 doctor's examination) | 1.3 AUC score*day | Standard Deviation 0.6 |
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Nasal/Throat/Chest (Days 1-5, patient diary data) | 13.4 AUC score*day | Standard Deviation 8 |
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | All symptoms (Days 1, 3, 6 doctor's examination) | 13.1 AUC score*day | Standard Deviation 5.7 |
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | All symptoms (Days 1-5, patient diary data) | 26.3 AUC score*day | Standard Deviation 14.8 |
| Ergoferon in Liquid Dosage Form | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Nasal/Throat/Chest (Days 1, 3, 6 doctor's examinat | 6.9 AUC score*day | Standard Deviation 3.6 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | All symptoms (Days 1-5, patient diary data) | 29.6 AUC score*day | Standard Deviation 14.1 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Non-specific (Days 1, 3, 6 doctor's examination) | 5.2 AUC score*day | Standard Deviation 2.6 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Nasal/Throat/Chest (Days 1, 3, 6 doctor's examinat | 7.2 AUC score*day | Standard Deviation 3.3 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | All symptoms (Days 1, 3, 6 doctor's examination) | 13.9 AUC score*day | Standard Deviation 5.3 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Fever (Days 1-5, patient diary data) | 2.6 AUC score*day | Standard Deviation 1.7 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Non-specific (Days 1-5, patient diary data) | 10.1 AUC score*day | Standard Deviation 6.6 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Nasal/Throat/Chest (Days 1-5, patient diary data) | 14.4 AUC score*day | Standard Deviation 7.1 |
| Placebo | Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) | Fever (Days 1, 3, 6 doctor's examination) | 1.5 AUC score*day | Standard Deviation 0.7 |
Comparison: Fever (Days 1, 3, 6 doctor's examination)p-value: 0.0166Kruskal-Wallis
Comparison: Non-specific (Days 1, 3, 6 doctor's examination)p-value: 0.082Kruskal-Wallis
Comparison: Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination)p-value: 0.7227Kruskal-Wallis
Comparison: All symptoms (Days 1, 3, 6 doctor's examination)p-value: 0.2645Kruskal-Wallis
Comparison: Fever (Days 1-5, patient diary data)p-value: 0.0142Kruskal-Wallis
Comparison: Non-specific (Days 1-5, patient diary data)p-value: 0.0145Kruskal-Wallis
Comparison: Nasal/Throat/Chest (Days 1-5, patient diary data)p-value: 0.2963Kruskal-Wallis
Comparison: All symptoms (Days 1-5, patient diary data)p-value: 0.0364Kruskal-Wallis