N/A
Completed N=8,411
Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.
Source: ClinicalTrials.gov NCT04413929 ↗Enrolled (actual)
8,411
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Duration of Influenza/ARVI Symptoms. — 4.84 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Influenza/ARVI Symptoms. |
4.84 | — |
| SECONDARY Duration of Increased Body Temperature. |
1.99 | — |
| SECONDARY Duration of Systemic Symptoms. |
2.33 | — |
| SECONDARY Duration of Nose Symptoms. |
2.9 | — |
| SECONDARY Duration of Throat Symptoms. |
2.9 | — |
| SECONDARY Percentage of Patients With Complications of Influenza/Acute Viral URI. |
1241 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04413929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.