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

Viral Respiratory Infection Clinical Trial

Official title: International Observational Non-Interventional Retrospective Program for Studying the Efficiency and Safety of Ergoferon in Patients With Influenza and Acute Respiratory Viral Infection (ARVI).

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections
• Viral Respiratory Infection

• NCT number: NCT04413929
• Study type: Observational
• Source: Materia Medica Holding
• Status: Completed
• Start date: October 2016
• Completion date: April 2017