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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04413929

Acronym

HERMITAGE

Enrollment

8411

Registered

2020-06-04

Start date

2016-10-31

Completion date

2017-04-30

Last updated

2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral Respiratory Infection

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).

Interventions

DRUGErgoferon

Oral administration

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 Throat Symptoms.	through study completion up to 1 month	Symptoms of the throat (sore throat, etc.). 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.

Participant flow

Participants by arm

Arm	Count
Ergoferon Oral administration in the therapeutic dosage specified in the instructions for medical use.	8,411
Total	8,411

Baseline characteristics

Characteristic	Ergoferon	—
Age, Continuous Adults	36.75 years STANDARD_DEVIATION 14.1	—
Age, Continuous All included patients	14.43 years STANDARD_DEVIATION 15.44	—
Age, Continuous Children	6.75 years STANDARD_DEVIATION 4.59	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Armenia	390 Participants	—
Region of Enrollment Azerbaijan	1015 Participants	—
Region of Enrollment Georgia	329 Participants	—
Region of Enrollment Kazakhstan	2718 Participants	—
Region of Enrollment Kyrgyzstan	807 Participants	—
Region of Enrollment Mongolia	451 Participants	—
Region of Enrollment Tajikistan	559 Participants	—
Region of Enrollment Uzbekistan	2142 Participants	—
Sex: Female, Male Female	4220 Participants	—
Sex: Female, Male Male	3971 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 8,411
other Total, other adverse events	0 / 8,411
serious Total, serious adverse events	0 / 8,411

Outcome results

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.