Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza

Phase

Condition

Influenza

Respiratory Syncytial Virus (Rsv) Infection

Common Cold

Treatment

Cycloferon

Placebo

Clinical Study ID

NCT06183229

CCF-III-TAB-2023

Ages 18-65
All Genders

Study 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.

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 ofcontraception during the entire period of participation in the study and for 3 weeksafter the end of 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/orduodenal 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 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 thetime 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 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

Cycloferon

September 15, 2023

June 10, 2024

Connect with a study center

Research Center for Eco-safety, Ltd.
Saint Petersburg, 196143
Russian Federation
Site Not Available
City Outpatient Clinic #117
Saint-Petersburg,
Russian Federation
Site Not Available

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