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The observational study to get the additional data of the safety and effectiveness of Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.
This observational study is aimed to provide additional safety and effectiveness data for Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients, including cases with delayed treatment initiation of illness, and in allergy patients. Routine clinical practice in the management of outpatients with ARVI is to be studied in Azerbaijan, Armenia, Georgia, Kazakhstan, Kyrgyzstan, Mongolia, Tajikistan and Uzbekistan: the demographic characteristics of patients, duration and time points of treatment with the use of Ergoferon, its safety, and the frequency of additional medication.
Scope of the study: 519 general practitioners; 8411 patients. Physical examinations and tests are performed according to local outpatient clinical practice, and to local and international medical care standards.
Data to be collected and analyzed after the completion of treatment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ergoferon | Oral administration in the therapeutic dosage specified in the instructions for medical use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergoferon | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Influenza/ARVI Symptoms. | The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data. | through study completion up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Increased Body Temperature. | A body temperature ≥37.0 °С. Based on Case Report Form data. | through study completion up to 1 month |
| Duration of Systemic Symptoms. | Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite). Based on Case Report Form data. |
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Inclusion Criteria:
Exclusion Criteria:
Not applicable.
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Children from 6 months to 18 years of age and adults over 18 years of age in any gender and demographic proportion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ergoferon | Oral administration in the therapeutic dosage specified in the instructions for medical use: 8 tablets on the first day of treatment (1 tablet every 30 minutes during the first 2 hours, then 3 more tablet intakes with regular intervals in between);from the second day until recovery take 1 tablet 3 times a day. The duration of the reception was regulated by the physician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ergoferon | Oral administration in the therapeutic dosage specified in the instructions for medical use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Children (age under 18) and adults presented separately. A number of patients did not reported their age (N=337) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Influenza/ARVI Symptoms. | The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data. | Posted | Mean | Standard Deviation | days | through study completion up to 1 month |
|
|
Approximately 6 months
The collection of information was carried out in accordance with the legislation of the participating countries for spontaneous reports of AEs within the framework of the existing practice of ARVI management, monitoring of medical researchers was not carried out due to the non-interventional nature of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ergoferon | Oral administration in the therapeutic dosage specified in the instructions for medical use. Ergoferon: Oral administration in the therapeutic dosage specified in the instructions for medical use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director | MATERIA MEDICA HOLDING | +74952761571 | 302 | PutilovskiyMA@materiamedica.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2016 | Jan 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000621422 | ergoferon |
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| through study completion up to 1 month |
| Duration of Nose Symptoms. | Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data. | through study completion up to 1 month |
| Duration of Throat Symptoms. | Symptoms of the throat (sore throat, etc.). Based on Case Report Form data. | through study completion up to 1 month |
| Percentage of Patients With Complications of Influenza/Acute Viral URI. | Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period. | through study completion up to 1 month |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | A number of patients (N=220) did not reported their sex | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Duration of Increased Body Temperature. | A body temperature ≥37.0 °С. Based on Case Report Form data. | Posted | Mean | Standard Deviation | days | through study completion up to 1 month |
|
|
|
| Secondary | Duration of Systemic Symptoms. | Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite). Based on Case Report Form data. | Posted | Mean | Standard Deviation | days | through study completion up to 1 month |
|
|
|
| Secondary | Duration of Nose Symptoms. | Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data. | Posted | Mean | Standard Deviation | days | through study completion up to 1 month |
|
|
|
| Secondary | Duration of Throat Symptoms. | Symptoms of the throat (sore throat, etc.). Based on Case Report Form data. | Posted | Mean | Standard Deviation | days | through study completion up to 1 month |
|
|
|
| Secondary | Percentage of Patients With Complications of Influenza/Acute Viral URI. | Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period. | Posted | Count of Participants | Participants | through study completion up to 1 month |
|
|
|
| 0 |
| 8,411 |
| 0 |
| 8,411 |
| 0 |
| 8,411 |
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