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

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

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.

Study Overview

• Status: Completed
• Conditions: Viral Respiratory Infection
• Intervention / Treatment: Drug: Ergoferon

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 Type: Observational
• Enrollment (Actual): 8411

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children from 6 months to 18 years of age and adults over 18 years of age in any gender and demographic proportion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ergoferon; Oral administration in the therapeutic dosage specified in the instructions for medical use.	Drug: Ergoferon; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Materia Medica Holding

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: HERMITAGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No