Last updated: February 2, 2024
Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Overall Status: Active - Recruiting
Phase
3
Condition
Common Cold
Influenza
Respiratory Syncytial Virus (Rsv) Infection
Treatment
Cycloferon
Placebo
Clinical Study ID
NCT06183229
CCF-III-TAB-2023
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 viralinfection, diagnosed no more than 3 days ago.
- No signs of acute respiratory viral infection, influenza or COVID-19 at the time ofinclusion in the study.
- For women with preserved reproductive potential - a negative pregnancy test andconsent to use approved methods of contraception during the entire period ofparticipation in the study; for men - consent to use approved methods of contraceptionduring the entire period of participation in the study and for 3 weeks after the endof the study.
Exclusion
Exclusion Criteria:
- Known or suspected hypersensitivity to meglumine acridone acetate and/or any othercomponent of the drug/placebo.
- Lactose intolerance
- Diseases of the digestive system in the acute stage (erosions, gastric and/or duodenalulcers, 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 ofinclusion.
- Positive result of a rapid test for the presence of SARS-CoV-2 at the time ofscreening.
- 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 timeof 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 toscreening.
- Failure to observe the subject during the study period.
- Other reasons that, in the opinion of the researcher, prevent the subject fromparticipating in the study or create an unreasonable risk (for example, a history ofautoimmune diseases, etc.).
Study Design
Total Participants: 578
Treatment Group(s): 2
Primary Treatment: Cycloferon
Phase: 3
Study Start date:
September 15, 2023
Estimated Completion Date:
October 01, 2025
Connect with a study center
Research Center for Eco-safety, Ltd.
Saint Petersburg, 196143
Russian FederationActive - Recruiting
City Outpatient Clinic #117
Saint-Petersburg,
Russian FederationActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.