Clinical trial NCT04413929: Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.
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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Respiratory Infection
Lead sponsor: Materia Medica Holding
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 8411
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: Duration of Influenza/ARVI Symptoms.
timeFrame: through study completion up to 1 month
Secondary outcomes:
measure: Duration of Increased Body Temperature.
timeFrame: through study completion up to 1 month
measure: Duration of Systemic Symptoms.
timeFrame: through study completion up to 1 month
measure: Duration of Nose Symptoms.
timeFrame: through study completion up to 1 month
measure: Duration of Throat Symptoms.
timeFrame: through study completion up to 1 month
measure: Percentage of Patients With Complications of Influenza/Acute Viral URI.
timeFrame: through study completion up to 1 month
Other outcomes:
Locations:
Study officials:
References: