Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.

Completed

• Conditions: Viral Respiratory Infection
• Interventions: Drug: Ergoferon

• Registration Number: NCT04413929
• Lead Sponsor: Materia Medica Holding

Brief Summary

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.

Detailed Description

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:

* demographics (age, gender, and city/town of residence)

* severity of illness (mild, moderate, or severe)

* comorbidities (chronic ENT conditions, chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease, allergic rhinitis/sinusitis, atopic dermatitis/eczema, asthma, or other)

* the time of resolution of infection symptoms (absence of fever - a body temperature below 37.0°С), systemic symptoms (chills, headaches, myalgias, weakness, and loss of appetite), nasal symptoms (nasal congestion/ discharge), laryngeal symptoms (a sore throat, or other), and other symptoms

* illness time points: onset of illness, first visit to the doctor's office, and start of treatment.

* symptomatic therapy (drug name, date prescribed, and date discontinued)

* therapy for bacterial complications (date the antimicrobial drug is prescribed, drug name, diagnosis, hospitalization or no hospitalization required, date of hospitalization)

* serious adverse events (description of the event, causality (related/ not related to Ergoferon), severity, date of the onset, and actions taken)

* efficacy assessment of the Ergoferon treatment (high efficacy: recovery / satisfactory: improvement/ insufficient: no effect) - observational study model: cohort Cohort study is an observation of outcomes in a group of individuals linked by shared characteristics (an acute respiratory viral infections and use of Ergoferon).

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Results First Submitted: 2021-01-19
• Results First Submitted QC: 2021-03-09
• Last Update Submitted: 2021-03-09
• Results First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8411

Inclusion Criteria

• Data of children from 6 months to 18 years old and adults over 18 years old.
• Diagnosis: Flu / ARVI.
• Axillary temperature above 37.4 °С.
• At least one systemic and/or catarrhal symptom lasting 12 hours to 3 days by the time the doctor is consulted, for which treatment with Ergoferon is prescribed.
• A specific decision of the doctor to prescribe Ergoferon in strict accordance with the indications, regardless of the factor of including patient data in the program.
• CRF, filled by a doctor on the basis of medical documentation, at the end of patient observation.

Exclusion Criteria

Not applicable.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ergoferon	Ergoferon	Oral administration in the therapeutic dosage specified in the instructions for medical use.

Primary Outcome Measures

Name	Time	Method
Duration of Influenza/ARVI Symptoms.	through study completion up to 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Throat Symptoms.	through study completion up to 1 month	Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.
Duration of Nose Symptoms.	through study completion up to 1 month	Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.
Duration of Increased Body Temperature.	through study completion up to 1 month	A body temperature ≥37.0 °С. Based on Case Report Form data.
Duration of Systemic Symptoms.	through study completion up to 1 month	Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).; Based on Case Report Form data.
Percentage of Patients With Complications of Influenza/Acute Viral URI.	through study completion up to 1 month	Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period.