Trial Outcomes & Findings for Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza (NCT NCT01850446)
NCT ID: NCT01850446
Last Updated: 2020-04-16
Results Overview
Based on days 2-7 days of observation according to the patient's diary, and on days 3 and 7 according to the physician's examination.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
184 participants
Primary outcome timeframe
On 2-7 days of observation
Results posted on
2020-04-16
Participant Flow
Participant milestones
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
|
Overall Study
COMPLETED
|
87
|
90
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 13.7 • n=92 Participants
|
38.4 years
STANDARD_DEVIATION 14.4 • n=92 Participants
|
38.5 years
STANDARD_DEVIATION 13.9 • n=184 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=92 Participants
|
46 Participants
n=92 Participants
|
99 Participants
n=184 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=92 Participants
|
46 Participants
n=92 Participants
|
85 Participants
n=184 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Count of Participants
|
92 Participants
n=92 Participants
|
92 Participants
n=92 Participants
|
184 Participants
n=184 Participants
|
PRIMARY outcome
Timeframe: On 2-7 days of observationPopulation: Intention to treat \[ITT\]
Based on days 2-7 days of observation according to the patient's diary, and on days 3 and 7 according to the physician's examination.
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Morning, day 2 (patient diary data)
|
2 Participants
|
3 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Morning, day 3 (patient diary data)
|
2 Participants
|
3 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Morning, day 4 (patient diary data)
|
7 Participants
|
9 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Morning, day 5 (patient diary data)
|
31 Participants
|
21 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Morning, day 6 (patient diary data)
|
49 Participants
|
49 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Morning, day 7 (patient diary data)
|
68 Participants
|
62 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Evening, day 2 (patient diary data)
|
1 Participants
|
4 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Evening, day 3 (patient diary data)
|
3 Participants
|
6 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Evening, day 4 (patient diary data)
|
12 Participants
|
9 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Evening, day 5 (patient diary data)
|
36 Participants
|
31 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Evening, day 6 (patient diary data)
|
60 Participants
|
53 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Day 3 (physician's examination)
|
2 Participants
|
5 Participants
|
|
Percentage of Patients With Recovery/Improvement in Health Status.
Day 7 (physician's examination)
|
69 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: Baseline and days 2-7 of the observationPopulation: Intention to treat (ITT)
Fever changes over time (body temperature change on days 2-7 compared to baseline, based on patient diary data).
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Changes in Fever.
Morning, day 1
|
38.8 °C
Standard Deviation 0.5
|
38.7 °C
Standard Deviation 0.5
|
|
Changes in Fever.
Morning, day 2
|
37.8 °C
Standard Deviation 0.7
|
37.8 °C
Standard Deviation 0.8
|
|
Changes in Fever.
Morning, day 3
|
37.4 °C
Standard Deviation 0.6
|
37.2 °C
Standard Deviation 0.7
|
|
Changes in Fever.
Morning, day 4
|
37.0 °C
Standard Deviation 0.5
|
36.9 °C
Standard Deviation 0.5
|
|
Changes in Fever.
Morning, day 5
|
36.8 °C
Standard Deviation 0.4
|
36.7 °C
Standard Deviation 0.5
|
|
Changes in Fever.
Morning, day 6
|
36.6 °C
Standard Deviation 0.3
|
36.6 °C
Standard Deviation 0.4
|
|
Changes in Fever.
Morning, day 7
|
36.5 °C
Standard Deviation 0.3
|
36.5 °C
Standard Deviation 0.3
|
|
Changes in Fever.
Evening, day 1
|
38.3 °C
Standard Deviation 0.7
|
38.3 °C
Standard Deviation 0.8
|
|
Changes in Fever.
Evening, day 2
|
37.8 °C
Standard Deviation 0.6
|
37.7 °C
Standard Deviation 0.8
|
|
Changes in Fever.
Evening, day 3
|
37.3 °C
Standard Deviation 0.5
|
37.2 °C
Standard Deviation 0.7
|
|
Changes in Fever.
Evening, day 4
|
37.0 °C
Standard Deviation 0.4
|
37.0 °C
Standard Deviation 0.5
|
|
Changes in Fever.
Evening, day 5
|
36.8 °C
Standard Deviation 0.4
|
36.8 °C
Standard Deviation 0.4
|
|
Changes in Fever.
Evening, day 6
|
36.6 °C
Standard Deviation 0.3
|
36.7 °C
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: From the time of randomization until the time of recovery/improvement (days 1-7)Population: Intention to treat (ITT)
Criteria of no fever - body temperature lower than 37.0° C for 24 hours
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Average Duration of Fever.
|
3.77 days
Standard Error 0.13
|
3.54 days
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Days 2-7 of the observationPopulation: Intention to treat (ITT)
Based on patient's diary. Normal body temperature is no more than 37.0ºС.
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Percentage of Patients With Normal Body Temperature.
Evening, day 5
|
69 Participants
|
69 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Evening, day 6
|
83 Participants
|
78 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Morning, day 2
|
11 Participants
|
12 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Morning, day 3
|
21 Participants
|
31 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Morning, day 4
|
43 Participants
|
49 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Morning, day 5
|
68 Participants
|
72 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Morning, day 6
|
83 Participants
|
81 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Morning, day 7
|
90 Participants
|
88 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Evening, day 2
|
9 Participants
|
20 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Evening, day 3
|
17 Participants
|
29 Participants
|
|
Percentage of Patients With Normal Body Temperature.
Evening, day 4
|
45 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: On 1-7 days of observationPopulation: Intention to treat
The symptoms severity scale includes 14 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, stuffy nose, sneezing, sore throat, hoarseness, cough, chest pain). The severity of each non-specific and nasal/throat/chest symptom is scored on a 4-point scale (0=no symptom; 1=mild symptom; 2=moderate symptom; 3=severe symptom). The minimum value of each symptom is 0 points, and the maximum value is 4 points. The absolute body temperature (in degrees Celsius) is converted to relative units (or scores) using the following scale: ≤37.2С=0 points; 37.3-38.0С=1 point; 38.1-39.0С=2 points; ≥39.1С=3 points. The severity of symptoms is based on the physical examination of the patient by the physician on days 1, 3, and 7 and on the patient diary data on days 1-7. The minimum symptoms severity score is 0 points, the maximum score is 42 points.
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Day 7 (based on physician's objective examination)
|
2.0 score on a scale
Standard Deviation 3.1
|
2.0 score on a scale
Standard Deviation 2.5
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Morning, day 1 (patient diary data)
|
20.4 score on a scale
Standard Deviation 6.5
|
20.9 score on a scale
Standard Deviation 5.9
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Morning, day 2 (patient diary data)
|
16.3 score on a scale
Standard Deviation 6.8
|
15.7 score on a scale
Standard Deviation 7.1
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Morning, day 3 (patient diary data)
|
13.0 score on a scale
Standard Deviation 6.6
|
12.2 score on a scale
Standard Deviation 5.9
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Morning, day 4 (patient diary data)
|
8.7 score on a scale
Standard Deviation 5.3
|
8.0 score on a scale
Standard Deviation 5.4
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Morning, day 5 (patient diary data)
|
5.4 score on a scale
Standard Deviation 4.8
|
5.7 score on a scale
Standard Deviation 4.3
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Morning, day 6 (patient diary data)
|
3.6 score on a scale
Standard Deviation 3.7
|
3.7 score on a scale
Standard Deviation 3.4
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Morning, day 7 (patient diary data)
|
2.3 score on a scale
Standard Deviation 3.5
|
2.5 score on a scale
Standard Deviation 3.1
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Evening, day 1 (patient diary data)
|
18.8 score on a scale
Standard Deviation 6.8
|
18.2 score on a scale
Standard Deviation 7.0
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Evening, day 2 (patient diary data)
|
15.6 score on a scale
Standard Deviation 7.0
|
14.7 score on a scale
Standard Deviation 6.9
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Evening, day 3 (patient diary data)
|
11.4 score on a scale
Standard Deviation 6.1
|
10.1 score on a scale
Standard Deviation 5.7
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Evening, day 4 (patient diary data)
|
7.2 score on a scale
Standard Deviation 5.0
|
7.3 score on a scale
Standard Deviation 4.9
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Evening, day 5 (patient diary data)
|
4.9 score on a scale
Standard Deviation 4.4
|
4.6 score on a scale
Standard Deviation 4.0
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Evening, day 6 (patient diary data)
|
2.9 score on a scale
Standard Deviation 3.6
|
3.2 score on a scale
Standard Deviation 3.4
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Day 1 (based on physician's objective examination)
|
19.7 score on a scale
Standard Deviation 6.6
|
20.1 score on a scale
Standard Deviation 6.1
|
|
Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.
Day 3 (based on physician's objective examination)
|
12.7 score on a scale
Standard Deviation 6.3
|
11.3 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: On 1-7 days of observationPopulation: Intention to treat
Duration of clinical symptoms of influenza (fever, non-specific symptoms and nasal/ throat/ chest symptoms) in days based on the result of the patient's diary data
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
Fever
|
2.96 days
Standard Deviation 0.13
|
2.86 days
Standard Deviation 0.16
|
|
Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
Non-specific symptoms
|
4.82 days
Standard Deviation 0.12
|
5.0 days
Standard Deviation 0.11
|
|
Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.
Nasal/ throat/ chest symptoms
|
4.83 days
Standard Deviation 0.15
|
5.08 days
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: On days 1-7 of the observation.Population: Intention to treat
Based on the patient diary. The severity of influenza based on the data on the "Area Under Curve" for total index of influenza severity.
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
The Severity of Influenza.
|
59.88 score*day
Standard Deviation 24.82
|
57.88 score*day
Standard Deviation 25.08
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4 and 5 of the treatmentPopulation: Intention to treat
Antipyretics, which are allowed for use during clinical trial, are: 1. Paracetamol; 2. Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol).
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Day 1
|
64 Participants
|
59 Participants
|
|
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Day 2
|
39 Participants
|
38 Participants
|
|
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Day 3
|
14 Participants
|
11 Participants
|
|
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Day 4
|
1 Participants
|
3 Participants
|
|
Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.
Day 5
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: On 1-7 days of observation.Population: Intention to treat \[ITT\]
Based on patient's diary, objective examination (according to physician's objective examination). The patients with the development of disease complications and exacerbation of the disease course (the development of severe influenza).
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Percentage of Patients Requiring Antibiotics Administration.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: On days 3, 5, 7 of observation.Population: The number of patients to whom RT-PCR of the nasal samples was performed does not match the total number of patients in the ITT set due to the fact that not all nasopharyngeal samples were tested (due to violations of storage conditions in the centres before their transportation to the central laboratory).
Based on medical records of patients whose nasopharyngeal swabs submitted for Reverse Transcription Polymerase Chain Reaction (RT-PCR) were negative for influenza A/B virus.
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=69 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=77 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Proportion of Patients With Negative Results of Virological Analysis.
Day 3
|
45 Participants
|
50 Participants
|
|
Proportion of Patients With Negative Results of Virological Analysis.
Day 5
|
57 Participants
|
70 Participants
|
|
Proportion of Patients With Negative Results of Virological Analysis.
Day 7
|
65 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: On days1, 3 and 7 of observation.Population: Intention to treat \[ITT\]
The concentration of regulators of the T-cell immune response (IL2, IFN -γ, IL-18), and regulators of В-cell immune response (IL-4, IL-16).
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=19 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=31 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-2/Day1
|
3.25 pg/mL
Standard Deviation 2.70
|
4.26 pg/mL
Standard Deviation 3.38
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-2/Day3
|
4.40 pg/mL
Standard Deviation 4.31
|
3.52 pg/mL
Standard Deviation 2.59
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-2/Day7
|
4.65 pg/mL
Standard Deviation 4.07
|
4.39 pg/mL
Standard Deviation 3.29
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IFN-γ/Day1
|
5.11 pg/mL
Standard Deviation 2.28
|
9.91 pg/mL
Standard Deviation 8.78
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IFN-γ/Day3
|
7.21 pg/mL
Standard Deviation 4.24
|
7.76 pg/mL
Standard Deviation 5.25
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IFN-γ/Day7
|
9.00 pg/mL
Standard Deviation 5.25
|
6.63 pg/mL
Standard Deviation 11.03
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-18/Day1
|
238.99 pg/mL
Standard Deviation 138.86
|
192.15 pg/mL
Standard Deviation 119.85
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-18/Day3
|
277.74 pg/mL
Standard Deviation 188.73
|
220.64 pg/mL
Standard Deviation 152.33
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-18/Day7
|
239.84 pg/mL
Standard Deviation 140.24
|
195.01 pg/mL
Standard Deviation 134.45
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-4/Day1
|
1.26 pg/mL
Standard Deviation 1.40
|
1.39 pg/mL
Standard Deviation 0.75
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-4/Day3
|
1.54 pg/mL
Standard Deviation 1.83
|
1.21 pg/mL
Standard Deviation 0.61
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-4/Day7
|
1.51 pg/mL
Standard Deviation 1.41
|
1.32 pg/mL
Standard Deviation 0.55
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-16/Day1
|
28.40 pg/mL
Standard Deviation 30.16
|
60.41 pg/mL
Standard Deviation 46.37
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-16/Day3
|
44.26 pg/mL
Standard Deviation 75.11
|
58.15 pg/mL
Standard Deviation 46.15
|
|
Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).
IL-16/Day7
|
45.36 pg/mL
Standard Deviation 74.18
|
64.45 pg/mL
Standard Deviation 44.13
|
SECONDARY outcome
Timeframe: On day 1, 3 and 7 of observation.Population: Intention to treat \[ITT\]
Level of spontaneous and induced production of IFN-α and IFN-γ (in vitro).
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=19 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=31 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Spontaneous IFN-γ/Day3
|
20.79 pg/mL
Standard Deviation 21.16
|
11.99 pg/mL
Standard Deviation 12.34
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Spontaneous IFN-α/Day1
|
11.42 pg/mL
Standard Deviation 5.01
|
8.25 pg/mL
Standard Deviation 7.91
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Spontaneous IFN-α/Day3
|
12.39 pg/mL
Standard Deviation 6.20
|
6.19 pg/mL
Standard Deviation 4.33
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Spontaneous IFN-α/Day7
|
8.04 pg/mL
Standard Deviation 4.36
|
6.12 pg/mL
Standard Deviation 4.00
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Induced IFN-α/Day1
|
13.30 pg/mL
Standard Deviation 5.52
|
13.58 pg/mL
Standard Deviation 11.31
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Induced IFN-α/Day3
|
12.98 pg/mL
Standard Deviation 4.51
|
9.73 pg/mL
Standard Deviation 6.48
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Induced IFN-α/Day7
|
9.06 pg/mL
Standard Deviation 2.22
|
8.55 pg/mL
Standard Deviation 4.16
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Spontaneous IFN-γ/Day1
|
14.27 pg/mL
Standard Deviation 6.15
|
10.73 pg/mL
Standard Deviation 7.33
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Spontaneous IFN-γ/Day7
|
10.34 pg/mL
Standard Deviation 6.30
|
17.00 pg/mL
Standard Deviation 23.99
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Induced IFN-γ/Day1
|
113.31 pg/mL
Standard Deviation 157.45
|
164.92 pg/mL
Standard Deviation 156.01
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Induced IFN-γ/Day3
|
84.16 pg/mL
Standard Deviation 75.58
|
177.92 pg/mL
Standard Deviation 208.27
|
|
Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).
Induced IFN-γ/Day7
|
95.16 pg/mL
Standard Deviation 82.51
|
154.31 pg/mL
Standard Deviation 156.57
|
SECONDARY outcome
Timeframe: On days 1, 3 and 7 of observation.Population: Intention to treat \[ITT\]
The absolute number of each type of white blood cells (WBC): Absolut Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=19 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=31 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD4+/Day3
|
1.02 10^9 cells/L
Standard Deviation 0.39
|
0.95 10^9 cells/L
Standard Deviation 0.38
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of leukocytes/Day1
|
5.47 10^9 cells/L
Standard Deviation 1.74
|
5.33 10^9 cells/L
Standard Deviation 1.57
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of leukocytes/Day3
|
4.98 10^9 cells/L
Standard Deviation 1.73
|
4.61 10^9 cells/L
Standard Deviation 1.49
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of leukocytes/Day7
|
5.81 10^9 cells/L
Standard Deviation 1.96
|
6.50 10^9 cells/L
Standard Deviation 1.80
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of neutrophils/Day1
|
3.39 10^9 cells/L
Standard Deviation 1.43
|
3.23 10^9 cells/L
Standard Deviation 1.25
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of neutrophils/Day3
|
2.32 10^9 cells/L
Standard Deviation 1.08
|
2.13 10^9 cells/L
Standard Deviation 1.12
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of neutrophils/Day7
|
2.73 10^9 cells/L
Standard Deviation 1.28
|
3.45 10^9 cells/L
Standard Deviation 1.54
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of lymphocytes/Day1
|
1.37 10^9 cells/L
Standard Deviation 0.67
|
1.26 10^9 cells/L
Standard Deviation 0.48
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of lymphocytes/Day3
|
1.98 10^9 cells/L
Standard Deviation 0.69
|
1.86 10^9 cells/L
Standard Deviation 0.57
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of lymphocytes/Day7
|
2.46 10^9 cells/L
Standard Deviation 0.91
|
2.41 10^9 cells/L
Standard Deviation 0.63
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of monocytes/Day1
|
0.62 10^9 cells/L
Standard Deviation 0.30
|
0.73 10^9 cells/L
Standard Deviation 0.27
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of monocytes/Day3
|
0.58 10^9 cells/L
Standard Deviation 0.25
|
0.50 10^9 cells/L
Standard Deviation 0.20
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of monocytes/Day7
|
0.47 10^9 cells/L
Standard Deviation 0.18
|
0.49 10^9 cells/L
Standard Deviation 0.21
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of eosinophils/Day1
|
0.06 10^9 cells/L
Standard Deviation 0.06
|
0.07 10^9 cells/L
Standard Deviation 0.09
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of eosinophils/Day3
|
0.07 10^9 cells/L
Standard Deviation 0.06
|
0.10 10^9 cells/L
Standard Deviation 0.09
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of eosinophils/Day7
|
0.11 10^9 cells/L
Standard Deviation 0.09
|
0.12 10^9 cells/L
Standard Deviation 0.11
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of basophils/Day1
|
0.03 10^9 cells/L
Standard Deviation 0.02
|
0.04 10^9 cells/L
Standard Deviation 0.04
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of basophils/Day3
|
0.02 10^9 cells/L
Standard Deviation 0.02
|
0.03 10^9 cells/L
Standard Deviation 0.02
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of basophils/Day7
|
0.04 10^9 cells/L
Standard Deviation 0.02
|
0.03 10^9 cells/L
Standard Deviation 0.02
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+/Day1
|
1.06 10^9 cells/L
Standard Deviation 0.60
|
1.17 10^9 cells/L
Standard Deviation 0.91
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+/Day3
|
1.59 10^9 cells/L
Standard Deviation 0.55
|
1.48 10^9 cells/L
Standard Deviation 0.54
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+/Day7
|
1.89 10^9 cells/L
Standard Deviation 0.77
|
1.86 10^9 cells/L
Standard Deviation 0.57
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD4+/Day1
|
0.66 10^9 cells/L
Standard Deviation 0.41
|
0.74 10^9 cells/L
Standard Deviation 0.61
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD4+/Day7
|
1.24 10^9 cells/L
Standard Deviation 0.60
|
1.22 10^9 cells/L
Standard Deviation 0.46
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD8+/Day1
|
0.36 10^9 cells/L
Standard Deviation 0.22
|
0.38 10^9 cells/L
Standard Deviation 0.33
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD8+/Day3
|
0.52 10^9 cells/L
Standard Deviation 0.22
|
0.47 10^9 cells/L
Standard Deviation 0.20
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD8+/Day7
|
0.61 10^9 cells/L
Standard Deviation 0.28
|
0.59 10^9 cells/L
Standard Deviation 0.19
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD16+CD56+/Day1
|
0.07 10^9 cells/L
Standard Deviation 0.06
|
0.09 10^9 cells/L
Standard Deviation 0.16
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD16+CD56+/Day3
|
0.11 10^9 cells/L
Standard Deviation 0.09
|
0.07 10^9 cells/L
Standard Deviation 0.04
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD16+CD56+/Day7
|
0.10 10^9 cells/L
Standard Deviation 0.10
|
0.07 10^9 cells/L
Standard Deviation 0.05
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3-CD16+CD56+/Day1
|
0.15 10^9 cells/L
Standard Deviation 0.11
|
0.16 10^9 cells/L
Standard Deviation 0.18
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3-CD16+CD56+/Day3
|
0.19 10^9 cells/L
Standard Deviation 0.14
|
0.16 10^9 cells/L
Standard Deviation 0.13
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3-CD16+CD56+/Day7
|
0.17 10^9 cells/L
Standard Deviation 0.15
|
0.17 10^9 cells/L
Standard Deviation 0.11
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3-CD8+/Day1
|
0.05 10^9 cells/L
Standard Deviation 0.03
|
0.06 10^9 cells/L
Standard Deviation 0.09
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3-CD8+/Day3
|
0.08 10^9 cells/L
Standard Deviation 0.06
|
0.07 10^9 cells/L
Standard Deviation 0.05
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3-CD8+/Day7
|
0.09 10^9 cells/L
Standard Deviation 0.07
|
0.07 10^9 cells/L
Standard Deviation 0.05
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD19+CD3-/Day1
|
0.19 10^9 cells/L
Standard Deviation 0.14
|
0.20 10^9 cells/L
Standard Deviation 0.12
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD19+CD3-/Day3
|
0.20 10^9 cells/L
Standard Deviation 0.15
|
0.20 10^9 cells/L
Standard Deviation 0.09
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD19+CD3-/Day7
|
0.31 10^9 cells/L
Standard Deviation 0.20
|
0.33 10^9 cells/L
Standard Deviation 0.18
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD119+/Day1
|
1.39 10^9 cells/L
Standard Deviation 0.67
|
1.53 10^9 cells/L
Standard Deviation 1.09
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD119+/Day3
|
1.98 10^9 cells/L
Standard Deviation 0.7
|
1.85 10^9 cells/L
Standard Deviation 0.58
|
|
Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
AC of CD3+CD119+/Day7
|
2.37 10^9 cells/L
Standard Deviation 0.94
|
2.39 10^9 cells/L
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: On days 1, 3 and 7 of observation.Population: Intention to treat \[ITT\]
The relative percentage of each type of white blood cells (WBC): Relative Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.
Outcome measures
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=19 Participants
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=31 Participants
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of neutrophils/Day1
|
60.59 Percentage of total white blood cells
Standard Deviation 12.71
|
55.60 Percentage of total white blood cells
Standard Deviation 11.82
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of neutrophils/Day3
|
47.59 Percentage of total white blood cells
Standard Deviation 9.03
|
45.83 Percentage of total white blood cells
Standard Deviation 11.09
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of neutrophils/Day7
|
47.94 Percentage of total white blood cells
Standard Deviation 11.48
|
52.53 Percentage of total white blood cells
Standard Deviation 11.05
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of lymphocytes/Day1
|
25.97 Percentage of total white blood cells
Standard Deviation 11.78
|
24.42 Percentage of total white blood cells
Standard Deviation 10.03
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of lymphocytes/Day3
|
40.72 Percentage of total white blood cells
Standard Deviation 8.10
|
41.99 Percentage of total white blood cells
Standard Deviation 12.26
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of lymphocytes/Day7
|
42.95 Percentage of total white blood cells
Standard Deviation 10.87
|
38.69 Percentage of total white blood cells
Standard Deviation 10.09
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of monocytes/Day1
|
11.53 Percentage of total white blood cells
Standard Deviation 5.01
|
13.97 Percentage of total white blood cells
Standard Deviation 4.04
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of monocytes/Day3
|
11.76 Percentage of total white blood cells
Standard Deviation 3.76
|
10.92 Percentage of total white blood cells
Standard Deviation 3.58
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of monocytes/Day7
|
8.36 Percentage of total white blood cells
Standard Deviation 2.56
|
7.64 Percentage of total white blood cells
Standard Deviation 2.00
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of eosinophils/Day1
|
1.05 Percentage of total white blood cells
Standard Deviation 1.07
|
1.32 Percentage of total white blood cells
Standard Deviation 1.55
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of eosinophils/Day3
|
1.28 Percentage of total white blood cells
Standard Deviation 1.11
|
2.07 Percentage of total white blood cells
Standard Deviation 2.04
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of eosinophils/Day7
|
1.86 Percentage of total white blood cells
Standard Deviation 1.53
|
1.85 Percentage of total white blood cells
Standard Deviation 1.65
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of basophils/Day1
|
0.48 Percentage of total white blood cells
Standard Deviation 0.30
|
0.76 Percentage of total white blood cells
Standard Deviation 0.56
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of basophils/Day3
|
0.46 Percentage of total white blood cells
Standard Deviation 0.32
|
0.58 Percentage of total white blood cells
Standard Deviation 0.40
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of basophils/Day7
|
0.61 Percentage of total white blood cells
Standard Deviation 0.42
|
0.41 Percentage of total white blood cells
Standard Deviation 0.29
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+/Day1
|
74.08 Percentage of total white blood cells
Standard Deviation 15.28
|
75.69 Percentage of total white blood cells
Standard Deviation 8.14
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+/Day3
|
80.62 Percentage of total white blood cells
Standard Deviation 7.26
|
79.75 Percentage of total white blood cells
Standard Deviation 7.82
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+/Day7
|
80.07 Percentage of total white blood cells
Standard Deviation 10.04
|
78.44 Percentage of total white blood cells
Standard Deviation 9.15
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD4+/Day1
|
46.63 Percentage of total white blood cells
Standard Deviation 13.95
|
48.32 Percentage of total white blood cells
Standard Deviation 9.83
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD4+/Day3
|
51.87 Percentage of total white blood cells
Standard Deviation 7.87
|
51.33 Percentage of total white blood cells
Standard Deviation 9.29
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD4+/Day7
|
52.06 Percentage of total white blood cells
Standard Deviation 10.16
|
51.55 Percentage of total white blood cells
Standard Deviation 11.63
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD8+/Day1
|
25.80 Percentage of total white blood cells
Standard Deviation 11.74
|
23.92 Percentage of total white blood cells
Standard Deviation 8.51
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD8+/Day3
|
26.36 Percentage of total white blood cells
Standard Deviation 8.07
|
25.21 Percentage of total white blood cells
Standard Deviation 5.64
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD8+/Day7
|
26.49 Percentage of total white blood cells
Standard Deviation 7.23
|
24.70 Percentage of total white blood cells
Standard Deviation 5.36
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD16+CD56+/Day1
|
4.99 Percentage of total white blood cells
Standard Deviation 3.36
|
4.66 Percentage of total white blood cells
Standard Deviation 3.48
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD16+CD56+/Day3
|
5.44 Percentage of total white blood cells
Standard Deviation 3.18
|
3.78 Percentage of total white blood cells
Standard Deviation 2.10
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3+CD16+CD56+/Day7
|
4.24 Percentage of total white blood cells
Standard Deviation 3.26
|
3.24 Percentage of total white blood cells
Standard Deviation 2.29
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3-CD16+56+/Day1
|
12.33 Percentage of total white blood cells
Standard Deviation 10.82
|
9.20 Percentage of total white blood cells
Standard Deviation 6.04
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3-CD16+56+/Day3
|
9.68 Percentage of total white blood cells
Standard Deviation 6.29
|
8.88 Percentage of total white blood cells
Standard Deviation 6.58
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3-CD16+56+/Day7
|
7.15 Percentage of total white blood cells
Standard Deviation 5.35
|
7.35 Percentage of total white blood cells
Standard Deviation 5.27
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3-CD8+/Day1
|
4.38 Percentage of total white blood cells
Standard Deviation 4.01
|
3.48 Percentage of total white blood cells
Standard Deviation 3.01
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3-CD8+/Day3
|
4.06 Percentage of total white blood cells
Standard Deviation 2.86
|
3.73 Percentage of total white blood cells
Standard Deviation 2.50
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD3-CD8+/Day7
|
3.55 Percentage of total white blood cells
Standard Deviation 2.32
|
3.18 Percentage of total white blood cells
Standard Deviation 2.02
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD19+CD3-/Day1
|
13.70 Percentage of total white blood cells
Standard Deviation 8.70
|
14.96 Percentage of total white blood cells
Standard Deviation 7.93
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD19+CD3-/Day3
|
9.71 Percentage of total white blood cells
Standard Deviation 4.05
|
10.79 Percentage of total white blood cells
Standard Deviation 4.85
|
|
Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).
RC of CD19+CD3-/Day7
|
12.82 Percentage of total white blood cells
Standard Deviation 5.45
|
14.56 Percentage of total white blood cells
Standard Deviation 7.35
|
Adverse Events
Ergoferon (1 Tablet 3 Times a Day)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 participants at risk
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 participants at risk
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
General disorders
Hyperthermia
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
Other adverse events
| Measure |
Ergoferon (1 Tablet 3 Times a Day)
n=92 participants at risk
Ergoferon: The treatment period is 5 days. Oral Dose per administration: 1 tablet. The tablet should be kept in the mouth until completely dissolution, the drug is taken without regard to food intake.
Dosing scheme. One tablet every 30 minutes for the first 2 hours, then during the first day, three more doses are taken at equal intervals. From the second to the fifth day, the drug is taken 1 tablet 3 times a day.
|
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
n=92 participants at risk
Oseltamivir: The treatment period is 5 days.
1 capsule (75 mg) twice a day during the meal or regardless of meal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Eye disorders
Eye pain
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
2.2%
2/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Eye disorders
Photophobia
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
3.3%
3/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
General disorders
Chest pain
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
General disorders
Hyperthermia
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Infections and infestations
Bronchitis
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Nervous system disorders
Dizziness
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Nervous system disorders
Dysgeusia
|
2.2%
2/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
0.00%
0/92 • Adverse/Serious adverse events were collected for 7 days (5 days of the therapy plus follow-up period).
Adverse/Serious adverse events were collected in patients of the Safety population (n=184)
|
Additional Information
Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director
Materia Medica Holding
Phone: +74952761571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place