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

NCT ID: NCT04413929

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8411 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-04-30

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).

Conditions

Viral Respiratory Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ergoferon

Oral administration in the therapeutic dosage specified in the instructions for medical use.

Ergoferon

Intervention Type: DRUG

Oral administration

Interventions

Ergoferon

Oral administration

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materia Medica Holding

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HERMITAGE

Identifier Type: -

Identifier Source: org_study_id