Status:
COMPLETED
Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Influenza
Acute Respiratory Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of p...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18 to 65 years inclusive.
- Written informed consent.
- Co-living with persons who has developed influenza or other acute respiratory viral infection, diagnosed no more than 3 days ago.
- No signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion in the study.
- For women with preserved reproductive potential - a negative pregnancy test and consent to use approved methods of contraception during the entire period of participation in the study; for men - consent to use approved methods of contraception during the entire period of participation in the study and for 3 weeks after the end of the study.
Exclusion
- Known or suspected hypersensitivity to meglumine acridone acetate and/or any other component of the drug/placebo.
- Lactose intolerance
- Diseases of the digestive system in the acute stage (erosions, gastric and/or duodenal ulcers, gastritis and duodenitis).
- History of allergic reactions.
- Decompensated liver cirrhosis.
- Diseases of the thyroid gland.
- Congenital or acquired immunodeficiency.
- Signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion.
- Positive result of a rapid test for the presence of SARS-CoV-2 at the time of screening.
- Vaccination to prevent COVID-19 and/or influenza within 6 months before screening, planned vaccination during a clinical trial.
- History of positive test result for HIV types 1 or 2.
- Pregnancy or breastfeeding period (for women).
- Alcoholism, drug addiction, substance and/or drug abuse in history and/or at the time of screening.
- Participation in another clinical trial within 3 months before inclusion.
- Subject is already receiving cycloferon.
- Subject is receiving prohibited therapy or was receiving it within 30 days prior to screening.
- Failure to observe the subject during the study period.
- Other reasons that, in the opinion of the researcher, prevent the subject from participating in the study or create an unreasonable risk (for example, a history of autoimmune diseases, etc.).
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06183229
Start Date
September 15 2023
End Date
June 10 2024
Last Update
April 29 2025
Active Locations (2)
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1
Research Center for Eco-safety, Ltd.
Saint Petersburg, Russia, 196143
2
City Outpatient Clinic #117
Saint Petersburg, Russia