Ergoferon
DrugOral administration
NCT Number: NCT04413929
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.
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Notify Me6 month–75 year
All sexes
Observational
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Not applicable.
Oral administration
Time frame: 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.
Time frame: through study completion up to 1 month
A body temperature ≥37.0 °С. Based on Case Report Form data.
Time frame: through study completion up to 1 month
Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).
Based on Case Report Form data.
Time frame: 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.
Time frame: through study completion up to 1 month
Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.
Time frame: 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.
Materia Medica Holding
Industry
International Observational Non-Interventional Retrospective Program for Studying the Efficiency and Safety of Ergoferon in Patients With Influenza and Acute Respiratory Viral Infection (ARVI).
Acronym: HERMITAGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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