Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06183229
Other study ID # CCF-III-TAB-2023
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 15, 2023
Est. completion date October 1, 2025

Study information

Verified date February 2024
Source POLYSAN Scientific & Technological Pharmaceutical Company
Contact Aleksey L Kovalenko, Doc Biol Sci
Phone +7 (812) 448-22-22
Email science@polysan.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs - immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, which is an interferon inducer. Interferons are the most important system of innate immunity, which has antiviral and immunomodulatory effects, and can protect the body from infection with a virus, and in case of infection, fight the causative agent of the disease. The planned clinical trial of the efficacy and safety of the drug CYCLOFERON in the dosage form of a tablet will study its ability to prevent influenza and other respiratory viral infections in adults who have already had close contact with patients with manifest disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 578
Est. completion date October 1, 2025
Est. primary completion date September 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Male and female subjects aged 18 to 65 years inclusive. 2. Written informed consent. 3. Co-living with persons who has developed influenza or other acute respiratory viral infection, diagnosed no more than 3 days ago. 4. No signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion in the study. 5. 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 Criteria: 1. Known or suspected hypersensitivity to meglumine acridone acetate and/or any other component of the drug/placebo. 2. Lactose intolerance 3. Diseases of the digestive system in the acute stage (erosions, gastric and/or duodenal ulcers, gastritis and duodenitis). 4. History of allergic reactions. 5. Decompensated liver cirrhosis. 6. Diseases of the thyroid gland. 7. Congenital or acquired immunodeficiency. 8. Signs of acute respiratory viral infection, influenza or COVID-19 at the time of inclusion. 9. Positive result of a rapid test for the presence of SARS-CoV-2 at the time of screening. 10. Vaccination to prevent COVID-19 and/or influenza within 6 months before screening, planned vaccination during a clinical trial. 11. History of positive test result for HIV types 1 or 2. 12. Pregnancy or breastfeeding period (for women). 13. Alcoholism, drug addiction, substance and/or drug abuse in history and/or at the time of screening. 14. Participation in another clinical trial within 3 months before inclusion. 15. Subject is already receiving cycloferon. 16. Subject is receiving prohibited therapy or was receiving it within 30 days prior to screening. 17. Failure to observe the subject during the study period. 18. 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.).

Study Design


Intervention

Drug:
Cycloferon
Cycloferon, enteric-coated tablets, 150 mg, 4 tablets (600 mg) per day on days 1, 2, 4, 6 and 8.
Placebo
Placebo tablets, 4 tablets per day on days 1, 2, 4, 6 and 8

Locations

Country Name City State
Russian Federation Research Center for Eco-safety, Ltd. Saint Petersburg
Russian Federation Research Center for Eco-safety, Ltd. Saint Petersburg
Russian Federation City Outpatient Clinic #117 Saint-Petersburg

Sponsors (1)

Lead Sponsor Collaborator
POLYSAN Scientific & Technological Pharmaceutical Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of influenza/other acute respiratory viral infection in the study groups the proportion of subjects with clinically manifest and laboratory confirmed influenza or other acute respiratory viral infection, developed within days 1-14 of the study. 14 days
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A